Release Date:  

RFA: HL-98-009


National Heart, Lung, and Blood Institute

Letter of Intent Receipt Date:  July 1, 1998
Application Receipt Date:  August 26, 1998



The goal of this RFA is to develop new animal and cellular models to study the
interrelationships of atherosclerosis and hypertension, to encourage basic
research on cellular and molecular mechanisms leading to the concurrent
development of high blood pressure and atherosclerosis, and to identify the
pathways by which either one of these conditions might influence the severity
of the other.


The Public Health Service (PHS) is committed to achieving the health promotion
and disease prevention objectives of "Healthy People 2000," a PHS-led national
activity for setting priority areas.  This initiative is related to the
priority area of heart disease and stroke.  Potential applicants may obtain a
copy of "Healthy People 2000" (Full Report: Stock No.017-001-00474-0 or
Summary Report: Stock No.017-001-00473-1) through the Superintendent of
Documents, Government Printing Office, Washington, DC 20402-9325 (telephone


Applications may be submitted by domestic and foreign, for-profit and
non-profit organizations, public and private, such as universities, colleges,
hospitals, laboratories, units of state or local governments, and eligible
agencies of the federal government.  Racial and ethnic minority individuals,
women, and persons with disabilities are encouraged to apply as principal

All current policies and requirements that govern the research grant programs
of the National Institutes of Health (NIH) will apply to grants awarded under
this RFA.  Awards under this RFA to foreign institutions will be made only for
research of very unusual merit, need, and promise, and in accordance with PHS
policy governing such awards.  Cell biology, molecular biology, biochemistry,
physiology, pathology, pharmacology, and genetics are among the disciplines
and expertise that are appropriate for this research program.


The mechanism available for support of applications in response to this RFA is
the regular research project grant (R01).  Specific application instructions
have been modified to reflect "Modular Grant" and "Just-in-Time" streamlining
efforts being examined by the NIH.

The modular grant concept establishes specific budgetary modules, all of which
have a budget ceiling for direct costs.  Only limited budgetary information is
required under this approach (see below).  The just-in-time concept allows
applicants to submit certain administrative information only after scientific
peer review indicates there is a possibility for an award.  It is anticipated
that these changes will reduce the administrative burden for the applicants,
reviewers, and Institute staff.

For this RFA, funds must be requested in $25,000 direct cost modules.  A
feature of the modular grant concept is that no escalation is provided for
future years, and all anticipated expenses for all years of the project must
be included within the number of modules being requested.  Only limited budget
information will be required and any budget adjustments made by the initial
review group will be in modules of $25,000.  A maximum of 8 modules ($200,000
direct costs) per R01 per year may be requested.

This RFA is a one-time solicitation.  Future unsolicited competing
continuation applications will compete with all investigator-initiated
applications and be reviewed according to the customary peer review
procedures.  It is anticipated that support for this program will begin in
April 1999.  Administrative adjustments in project period and amount may be
required at the time of the award.


It is anticipated that for fiscal year 1999, approximately $1,500,000 total
costs will be available to fund a maximum of 5 grants for the first year of
support under this RFA program.  Award of grants pursuant to this RFA is
contingent upon receipt of such funds for this purpose.  Applicants may
request up to 4 years of support.  The specific number to be funded will,
however, depend on the merit and scope of the applications received and on the
availability of funds.  Direct costs will be awarded in modules of $25,000,
less any overlap or other necessary administrative adjustments.  Facilities
and administrative costs will be awarded based on the negotiated rates.



As the cellular and molecular mechanisms of atherosclerosis and hypertension
are being more clearly defined, it is becoming apparent that the two processes
are interrelated.  However, few research proposals are currently supported by
the NHLBI that are directly studying the interaction of high blood pressure
and atherosclerosis.  A better understanding of the interrelationships between
high blood pressure and atherosclerosis may yield more rational clinical
strategies for the prevention and treatment of serious cardiovascular

Hypertension and atherosclerosis are among the major risk factors for coronary
artery disease, stroke, and kidney disease.  Results from the Lipid Research
Clinics Program Prevalence Study indicate that non-lipid coronary artery
disease risk factors, such as high blood pressure, tend to aggregate (for
hypertension up to 2.5 times more frequently) in individuals with high-risk
lipoprotein phenotypes.  Some estimates indicate that as many as 46 percent of
individuals with total blood cholesterol levels greater than 240 mg/dl have
blood pressures in excess of 140/90 mm Hg.  In addition, according to
unpublished data from the National Health and Nutrition Examination Survey II,
40 percent of individuals who have blood pressure in excess of 140/90 mm Hg or
who are taking antihypertensive medications have total cholesterol levels
greater than 240 mg/dl.  In comparison, only 25 percent of normotensive
individuals have total cholesterol levels greater than 240 mg/dl.

The Framingham Study and the Multiple Risk Factor Intervention Trial (MRFIT)
have demonstrated that moderate to severe hypertension significantly increases
the chances of atherogenesis.  In addition, MRFIT has shown a positive
correlation between the extent of hypertension and the incidence of coronary
heart disease.  The Pathobiological Determinants of Atherosclerosis in Youth
(PDAY) study has also accumulated a vast amount of data on atherogenesis, in
which the effects of blood pressure levels on plaque development have been
clearly demonstrated.  Specifically, hypertension was shown to be associated
with accelerated atherosclerosis, particularly with the development of fibrous
plaques.  Investigators in the Tromso Study in Norway found a statistically
significant association between high blood pressure and total cholesterol in
over 21,000 males and females.  These results suggest common features in the
development of both conditions. Thus, as a group, patients with both high
blood pressure and elevated cholesterol levels are at a higher risk for
experiencing untoward cardiovascular events.

In addition to clinical studies, a large body of descriptive data has been
gathered over the past two decades on interrelationships of atherosclerosis
and high blood pressure in experimental animal models.  Scientists have
demonstrated that induction of elevated blood pressures in the Watanabe
heritable hyperlipidemic rabbit model of atherosclerosis results in a
synergistic effect that leads to a dramatic enhancement of atherosclerotic
lesion formation.  A substantial body of evidence indicates that angiotensin
converting enzyme inhibitors are capable of reducing the extent of
atherosclerosis in hypertensive animal models.  Recently, a study in Dahl
salt-sensitive rats provided compelling data indicating that the cholesterol-
lowering drug, pravastatin, prevents the development of hypertension even when
rats are maintained on a high salt diet.  Investigators have also begun
exploring how the coagulation cascade and the renin-angiotensin system can
work together to increase the risk of atherosclerosis.  Although both clinical
and laboratory-based research implicate elevations in blood pressure as an
important force in accelerating atherosclerotic plaque development, little is
known about the cellular and molecular mechanisms by which high blood pressure
may increase the likelihood that atherosclerosis will develop.

Consistent with the idea of a common underlying pathology are the observations
that hypertension and atherosclerosis share a number of physiological and
biochemical features in the vessel wall.  Both are characterized by growth
(hypertrophy) and proliferation (hyperplasia) of smooth muscle cells in the
medial layer of the vessel, leading to an increased thickness in the vessel
wall.  In atherosclerosis and possibly in hypertension, smooth muscle cells
migrate from the media to the intima.  There is also deposition of connective
tissue in the extravascular matrix of the adventitial and medial layers that
contributes to the remodeling of the vessel, often permanently altering
vascular function.  An additional common feature is the recruitment of
monocytes, macrophages, and T cells into the arterial wall, a process that may
activate proinflammatory mechanisms in the vessel.  Lastly, endothelial
dysfunction, broadly defined as a loss of endothelial capacity to regulate
vascular smooth muscle cell tone and growth, occurs in both diseases.

Many non-hemodynamic factors within the vessel wall are known to change in
level or activity in concert with elevations in blood pressure and can mediate
vascular growth, inflammation, and oxidative stress.  Such factors can be
secreted by leukocytes, endothelial cells, vascular smooth muscle cells, and
fibroblasts, and include components of the renin-angiotensin system,
cytokines, growth factors, nitric oxide (NO), and oxygen-derived free

The oxidative stress that may be introduced in vascular smooth muscle cells by
a number of non-hemodynamic factors might accelerate lipid peroxidation and
foam cell formation from macrophages attracted to the vessel wall.  For
instance, decreased NO activity can result in enhanced vasomotor tone and
thereby promote inflammatory responses, such as vessel wall platelet adhesion
and smooth muscle cell proliferation.  Loss of the protective effects of NO
may predispose vessels to the development of secondary complications, such as
enhanced low density lipoprotein (LDL) oxidation and atherosclerosis.  Free
radical formation may also play an important role in the induction of early
functional changes of the vasculature.

Hence, interactions between a large number of vascular processes can be seen
to affect both the hypertensive and atherogenic processes.  Through the study
of these types of interactions, it may be possible to explain how hypertension
can accelerate and intensify the atherosclerotic process and how both
conditions develop and affect each other synergistically.  The development of
new models to study interrelationships between atherosclerosis and
hypertension may encourage more investigators to apply their basic scientific
knowledge to this important area of research.

Research Objectives

The goal of this initiative is to develop new animal and cellular models to
study the interrelationships of atherosclerosis and hypertension, to encourage
basic research on cellular and molecular mechanisms leading to the concurrent
development of high blood pressure and atherosclerosis, and to identify the
pathways by which either one of these conditions might influence the severity
of the other.

Both in vitro and in vivo research approaches will be necessary to clarify the
complex interactions between these two conditions.  Applications submitted in
response to this initiative must include studies on both atherosclerosis and
hypertension that will clearly investigate interrelationships between these
conditions at the biochemical, cellular, and genetic levels.  In addition,
studies using higher levels of physiological integration will be responsive to
the initiative and are encouraged, as long as cellular and molecular aspects
of the research are included.

Human studies will be considered if they address the mechanistic research
goals summarized elsewhere within this section.  However, due to the
limitations of the budget for this RFA, it is anticipated that human studies
would only be of a pilot nature or would only involve the use of human tissue
samples.  Clinical trials or population-based observational studies will not
be supported through this RFA program.

Applications that are not comprised of studies that are clearly investigating
the interrelationships of atherosclerosis and hypertension will be considered
unresponsive to this RFA and will be returned to the applicant without further
review.  Applications deemed unresponsive can be submitted to the NIH as an
investigator-initiated research project that will be reviewed in the usual

A few examples of research that would be considered responsive to the RFA are
listed below.  However, these areas are not inclusive and scientists are
strongly encouraged to discuss proposed submissions with the appropriate staff
at the NHLBI.  These individuals are listed in the section entitled INQUIRIES.

o  Development of genetically altered animals to study mechanistic questions
regarding high blood pressure and atherosclerosis, including animal models of
diseases and conditions, such as Type II Non-Insulin Dependent Diabetes
Mellitus or the Insulin Resistance Syndrome X, known to be associated with
elevated risks of cardiovascular diseases.

o  Clarification of the mechanisms underlying altered cellular function in the
vessel wall, such as generation of reactive oxidants involved in cell damage
and gene regulation, that lead to the development of hypertension and

o  Study of the role of the arterial extracellular matrix and cell integrins
in blood pressure-related arterial injury.

o  Studies on the mechanisms, such as changes in ion channel properties or
intracellular signaling, whereby blood pressure elevations and physical
forces, (e.g., vascular wall stress), modulate the response of the arterial
wall to atherosclerotic risk factors.

o  Pharmacological studies on how specific antihypertensive and hypoglycemic
agents affect the atherosclerotic and hypertensive processes.


Upon initiation of the program, the NHLBI will sponsor periodic meetings to
encourage exchange of information among investigators who participate in this
program.  Travel funds for a one-day meeting each year, most likely to be held
in Bethesda, Maryland, should be included in the modules.  Applicants should
also include a statement in their applications indicating their willingness to
participate in these meetings.


It is the policy of the NIH that women and members of minority groups and
their subpopulations must be included in all NIH supported biomedical and
behavioral research projects involving human subjects, unless a clear and
compelling rationale and justification is provided that inclusion is
inappropriate with respect to the health of the subjects or the purpose of the
research.  This policy results from the NIH Revitalization Act of 1993
(Section 492B of Public Law 103-43).

All investigators proposing research involving human subjects should read the
"NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical
Research," which has been published in the Federal Register of March 28, 1994
(FR 59 14508-14513) and in the NIH Guide to Grants and Contracts, Volume 23,
Number 11, March 18, 1994.  Investigators also may obtain copies of the policy
from the program staff listed under INQUIRIES.  Program staff may also provide
additional relevant information concerning the policy.


Prospective applicants are asked to submit, by July 1, 1998, a letter of
intent that includes a descriptive title of the proposed research, the name,
address, and telephone number of the principal investigator, the identities of
other key personnel and participating institutions, and the number and title
of the RFA in response to which the application may be submitted.  Although a
letter of intent is not required, is not binding, and does not enter into the
review of a subsequent application, the information that it contains allows
NHLBI staff to estimate the potential review workload and to avoid conflict of
interest in the review.

The letter of intent is to be mailed, or faxed, to:

C. James Scheirer, Ph.D.
Division of Extramural Affairs
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, Room 7220, MSC 7924
Bethesda, MD  20892-7924
Telephone:  (301) 435-0266
FAX:  (301) 480-3541
Email:  James_Scheirer@NIH.GOV


The research grant application form PHS 398 (rev. 5/95) is to be used in
applying for these grants, with the modifications noted below.  These forms
are available at most institutional offices of sponsored research; from the
Division of Extramural Outreach and Information Resources, National Institutes
of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone
301/710-0267, email: ASKNIH@od.nih.gov; and on the Internet at

The RFA label found in the PHS 398 application form must be affixed to the
bottom of the face page of the application.  Failure to use this label could
result in delayed processing of the application such that it may not reach the
review committee in time for review.  In addition, the RFA title (Cellular and
Molecular Interrelationships of Atherosclerosis and Hypertension) and number
(HL-98-009) must be typed on line 2 of the face page of the application form
and the YES box must be marked.  Sample budget and justification pages will be
provided upon request or following the submission of a letter of intent.  This
material can be obtained from Mr. William Darby at the address listed under

Instructions for completing the biographical sketch have been modified.  In
addition, other support information and the application checklist page are not
required as part of the initial application.  If there is a possibility for an
award, necessary budget, other support and checklist information will be
requested by National Heart, Lung, and Blood Institute (NHLBI) staff following
the initial review.  The APPLICATION PROCEDURES section of this RFA provides
specific details of modifications to standard PHS 398 application kit

BUDGET INSTRUCTIONS - The total direct costs must be requested in accordance
with the program guidelines and the modifications made to the standard PHS 398
application instructions described below:

FACE PAGE - As a reminder, Item 7 should be completed to indicate modular
direct costs requested and Item 8 should reflect total costs (modular direct
costs plus facilities and administrative costs).

the PHS 398 (rev 5/95).  It is not required nor will it be accepted at the
time of application.

categorical budget tables on page 5 of the PHS 398 (rev. 5/95) Form.  Only the
requested total direct costs line for each year must be completed based on the
number of modules being requested at $25,000 per module.

Applicants may not request a change in the amount of each module.  A maximum
of 8 modules ($200,000 direct costs) per R01 application per year may be
requested in response to this RFA.  Applicants may request up to 4 years of
support.  Direct cost budgets will remain constant throughout the life of the
project (i.e., the same number of modules requested for all budget periods). 
Any necessary escalation should be considered when determining the number of
modules to be requested.

However, in the event that the number of modules requested must change in any
future year due to the nature of the research proposed, appropriate
justification must be provided.  Total direct costs for the entire proposed
project period should be shown in the box provided on Form Page 5.


o Budget justifications should be provided under "Justifications" on Form Page
5 of the PHS 398.

o List the names and role on the project and proposed percent effort for all
project personnel (salaried or unsalaried) and provide a narrative
justification for each person based on his/her role on the project.

o Identify all consultants by name and organizational affiliation and describe
the services to be performed.

o Provide a general narrative justification for individual categories-----such
as equipment, supplies, and other expenses-----required to complete the work
proposed.  More detailed justifications should be provided for high cost
items.  Any large one-time purchases, such as large equipment requests, must
be accommodated within these limits.


If collaborations or subcontracts are involved that require transfer of funds
from the grantee to other institutions, it is necessary to establish formal
subcontractual agreements with each collaborating institution.  A letter of
intent from each collaborating institution should be submitted with the
application.  Only the percentage of the consortium/contractual total costs
(direct plus facilities and administrative costs) relative to the total direct
costs of the overall project needs to be stated at this time.

The following example should be used to indicate the percentage cost of the
consortium:  "The consortium agreement represents 27% of overall direct costs
requested in the first year."  A budget justification for the consortium
should be provided as described in the "Budget Justification" section above
(no Form Page 5 required for the consortium).  Please indicate whether the
consortium will be in place for the entire project period and identify any
future year changes in the percentage relative to the parent grant.

If there is a possibility for an award, the applicant will be requested to
identify actual direct and indirect costs for all years of the consortium. 
Please note that total subcontractual costs need not be calculated in $25,000
modules.  However, when subcontract funds are added to the parent grant
budget, the total direct cost amount must be included in the number of $25,000
modules requested.


A biographical sketch is required for all key personnel, following the
modified instructions below.  Do not exceed the two-page limit for each

o Complete the educational block at the top of the Form page;

o List current position(s) and those previous positions directly relevant to
the application;

o List selected peer-reviewed publications directly relevant to the proposed
project, with full citation; and

o The applicant has the option to provide information on research projects
completed and  research grants participated in during the last five years that
are relevant to the proposed project.


Do not complete the "Other Support" pages (Form Page 7).  Selected other
support information relevant to the proposed research may be included in the
Biographical Sketch as indicated above.  Complete "Other Support" information
will be requested by NHLBI staff if there is a possibility for an award.


No Checklist page is required as part of the initial application.  A completed
Checklist will be requested by NHLBI staff if there is a possibility for an
award.  The applicant should provide the name and phone number of the
individual to contact concerning fiscal and administrative issues if
additional information is necessary following the initial review. 
Applications not conforming to these guidelines will be considered
unresponsive to this RFA and will be returned without further review.

Submit a signed, typewritten original of the application and three signed,
photocopies, in one package to:

6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710
BETHESDA, MD  20892-7710
BETHESDA, MD  20817 (for express/courier service)

At the time of submission, two additional copies of the application should be
sent to C. James Scheirer, Ph.D. at the same address under LETTER OF INTENT.

Applications must be received by August 26, 1998.  If an application is
received after that date, it will be returned to the applicant without review. 
The Center for Scientific Review (CSR) will not accept any application in
response to this RFA that is essentially the same as one currently pending
initial review, unless the applicant withdraws the pending application.  The
CSR will not accept any application that is essentially the same as one
already reviewed.  This does not preclude the submission of substantial
revisions of applications already reviewed, but such applications must include
an introduction addressing the previous critique.


Upon receipt, applications will reviewed for completeness by the CSR and
responsiveness by the NHLBI.  Incomplete and/or unresponsive applications will
be returned to the applicant without further consideration.  Remaining
applications will be subjected to a streamlined review process by a Special
Emphasis Panel convened by NHLBI Scientific Review Office to determine their
scientific merit relative to other applications received in response to the
RFA.  The roster of reviewers for the RFA will be available on the NHLBI home
page approximately four weeks prior to the scheduled review date. 
Applications determined to be meritorious will be evaluated for scientific and
technical merit by the review committee, then discussed, and a priority score
will be assigned.  All other applications will not be discussed or scored. 
The initial review group will evaluate all applications as individual
investigator-initiated grant applications.  Secondary review of the
applications will be conducted by the National Heart, Lung, and Blood Advisory
Council (NHLBAC).

Review Criteria

The five criteria to be used in the evaluation of competing supplement
applications are listed below.  To put those criteria in context, the
following information is contained in instructions to the peer reviewers.

The goals of NIH-supported research are to advance our understanding of
biological systems, improve the control of disease, and enhance health.  The
reviewers will comment on the following aspects of the application in their
written critiques in order to judge the likelihood that the proposed research
will have a substantial impact on the pursuit of these goals.  Each of these
criteria will be addressed and considered by the reviewers in assigning the
overall score weighting them as appropriate for each application.  Note that
the application does not need to be strong in all categories to be judged
likely to have a major scientific impact and thus deserve a high priority
score.  For example, an investigator may propose to carry out important work
that by its nature is not innovative but is essential to move a field forward.

o Significance:  Does this study address an important problem?  If the aims of
the application are achieved, how will scientific knowledge be advanced?  What
will be the effect of these studies on the concepts or methods that drive this

o Approach:  Are the conceptual framework, design, methods, and analyses
adequately developed, well integrated, and appropriate to the aims of the
project?  Does the applicant acknowledge potential problem areas and consider
alternative tactics?

o Innovation:  Does the project employ novel concepts, approaches or method? 
Are the aims original and innovative?  Does the project challenge existing
paradigms or develop new methodologies or technologies?

o Investigator:  Is the investigator appropriately trained and well suited to
carry out this work?  Is the work proposed appropriate to the experience level
of the principal investigator and other researchers?

o Environment:  Does the scientific environment in which the work will be done
contribute to the probability of success?  Do the proposed experiments take
advantage of unique features of the scientific environment or employ useful
collaborative arrangements?  Is there evidence of institutional support?

The personnel category will be reviewed for appropriate staffing based on the
requested percent effort.  The direct costs budget request will be reviewed
for consistency with the proposed methods and specific aims.  Any budgetary
adjustments recommended by the reviewers will be in $25,000 modules.  The
duration of support will be reviewed to determine if it is appropriate to
ensure successful completion of the project.


Applications will receive a secondary level of review by NHLBAC at its
February 1999 meeting.  The earliest anticipated date of award is April 1999. 
Applicants should be aware that, in addition to scientific merit, program
priorities and program balance, the total cost of the proposed project, and
the availability of funds will be considered by NHLBI staff as well as the 
NHLBAC in making funding recommendations.  In addition, the NHLBI appreciates
the value of complementary funding from other public and private sources,
including foundations and industrial concerns.  In circumstances in which
applications have similar scientific merit, but vary in cost competitiveness,
the NHLBI is likely to select the more cost competitive application for


Letter of Intent Receipt Date:  July 1, 1998
Application Receipt Date:       August 26, 1998
Date of Initial Review:         November 1998
Review by NHLBAC:               February 1999
Anticipated Award Date:         April 1999


Inquiries concerning this RFA are encouraged.  The opportunity to clarify any
issues or questions from potential applicants is welcome.

Direct inquiries regarding scientific and programmatic issues to:

Paul A. Velletri, Ph.D.
Division of Heart and Vascular Diseases
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, Suite 10202
Bethesda, MD  20892-7956
Telephone:  (301) 435-0560
FAX:  (301) 480-2849
Email:  p4v@cu.nih.gov

Sonia I. Skarlatos, Ph.D.
Division of Heart and Vascular Diseases
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, Suite 10186
Bethesda, MD  20892-7956
Telephone:  (301) 435-0550
FAX:  (301) 480-2858
Email:  skarlats@gwgate.nhlbi.nih.gov

Direct inquiries regarding fiscal matters and requests for sample budget pages

Ms. Marie Willett
Grants Operations Branch
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, Suite 7156
Bethesda, MD  20892-7128
Telephone:  (301) 435-0144
FAX:  (301) 480-3310
Email:  Willettm@nhlbi.NIH.GOV


This program is described in the Catalog of Federal Domestic Assistance No.
93.837.  Awards are made under authorization of the Public Health Service Act,
Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC
241 and 285) and administered under PHS grants' policies and Federal
Regulations 42 CFR 52 and 45 CFR Part 74.  This program is not subject to the
intergovernmental review requirements of Executive Order 12372 or Health
Systems Agency review.

The PHS strongly encourages all grant and contract recipients to provide a
smoke-free workplace and promote the non-use of all tobacco products.  In
addition, Public Law 103-227, the Pro- Children Act of 1994, prohibits smoking
in certain facilities (or in some cases, any portion of a facility) in which
regular or routine education, library, day care, health care or early
childhood development services are provided to children.  This is consistent
with the PHS mission to protect and advance the physical and mental health of
the American people.

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