Notice Number: NOT-HL-11-106

Key Dates
Release Date:  March 24, 2010

Issued by
National Heart, Lung, and Blood Institute (NHLBI) (http://www.nhlbi.nih.gov/)

Purpose

The National Heart, Lung, and Blood Institute (NHLBI) intends to issue a renewal Funding Opportunity Announcement (FOA) to solicit applications for  Regional Clinical Centers (RCCs) which will participate in the Heart Failure Clinical Research Network. A separate FOA will seek applications for the combined Data Coordinating Center/Clinical Coordinating Center (CC).

The original Network (see WG, RFA-HL-05-003 and FAQ) was established to provide a mechanism to expedite clinical research that evaluates strategies to diagnose, manage and treat all forms of heart failure (HF). The renewal program, planned for seven years in duration, will continue to provide support to develop, coordinate, and conduct multiple collaborative randomized clinical trials (RCTs) to improve HF outcomes. The focus will be on small to intermediate-sized concurrent RCTs that can be completed within 2-5 years; the program will not be designed to fund large, Phase III definitive studies. Proposed interventions to be tested would be implemented by most, if not all, Network RCCs.

The Network would be expected to be able to concurrently successfully perform three or four trials, and NHLBI anticipates it would be able to complete two or three waves of trials in the planned seven-year period.

It is anticipated that the CC would provide leadership on all research operational issues for  the HF Network. The responsibilities of the CC would be to coordinate, administer, and support statistical study design, protocol development, data collection, quality control, and management of data integrity and analyses. Integral to the duties of the CC would be the clinical, regulatory, contractual, and logistical management required in the conduct of multiple concurrent studies performed across a Network of participating RCCs.

This Notice is being provided to allow potential applicants sufficient time to develop meaningful collaborations and responsive projects.  The FOA is expected to be published in the Fall 2010 with an expected receipt date in December 2010.

These FOAs will utilize the U10 cooperative agreement mechanism.

This Notice encourages investigators with expertise and insights into cardiovascular research to begin to consider planning for these FOAs.

APPLICATIONS ARE NOT BEING SOLICITED AT THIS TIME.

Inquiries

Interested parties may contact:

Alice Mascette, MD
Division of Cardiovascular Sciences
NHLBI
Rockledge 2, Room 8170
MSC 7956
6701 Rockledge Dr
Bethesda, MD 20892-7956
Telephone: (301) 435-0504
FAX: (301) 480-7404
E-mail: [email protected]

or

Monica R. Shah, MD, MHS, MSJ
Division of Cardiovascular Sciences
National Heart, Lung, and Blood Institute
National Institutes of Health
6701 Rockledge Drive, Room
Bethesda, MD 20892-7956
Telephone: (301) 594 4629
FAX: (301) 480 7404
E-mail: mailto:[email protected]