FYI from the NHLBI Index

December 2000: Vol. 1, Issue 3
Research and Resources

NHLBI Staff Visit Gene Therapy Research Centers

As part of ongoing efforts to ensure patient protection in gene therapy trials, the Food and Drug Administration and the National Institutes of Health (NIH) are taking extra steps to protect individuals enrolled in gene therapy studies. One such action is the implementation of "not for cause" site visits to clinical centers conducting NIH-supported gene therapy trials. This year, the NHLBI visited all five of its centers and will continue to visit each site on an annual basis as long as the gene therapy protocols are in effect. Future trips also will include visits to the newly implemented Programs of Excellence in Gene Therapy and to the Specialized Centers of Research in Hematopoietic Stem Cell Biology.

The objectives of the visits are to ensure the safety of participants and to be certain that the highest clinical standards are being applied in NHLBI-supported gene therapy trials. NHLBI staff review documents associated with the trials, visit facilities where the trials take place, and, perhaps most important establish a dialogue with the trials' investigators, management, and administrative staff.

The site visits are not the only way that NHLBI is enhancing its oversight of gene therapy trials. The Institute has increased its emphasis on training researchers about protection of research participants, identifying conflicts of interest, and establishing Data and Safety Monitoring Boards that are independent of other aspects of the trials.

Gene therapy is a recent, and still experimental, approach to treating, and possibly curing, diseases. The Institute is committed to holding gene transfer research to the highest ethical and scientific standards. Volunteers in clinical gene transfer trials should receive the greatest possible protection by investigators, institutions, and oversight agencies.

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Two New Programs from the NHLBI

On September 30, the NHLBI issued grants to investigators at 35 research settings that will establish 11 programs for genomic applications (PGAs). After identifying human genes particularly relevant to heart, lung, blood, and sleep functions, PGA researchers will decipher the genes' functions. "The PGA initiative is one of the NHLBI's most ambitious, wide-ranging efforts to date," says NHLBI Director Dr. Claude Lenfant. "Our challenge is to clearly identify the subsets of genes linked to heart, lung, blood, and sleep function, then to build upon this knowledge to develop better methods for prevention, diagnosis and therapy."

In another effort, the NHLBI launched the Multi-Ethnic Study of Atherosclerosis (MESA). The objective is to find heart disease before symptoms develop. "The earlier the risk of heart disease can be detected, the sooner steps can be taken to prevent its development," said Dr. Lenfant. "Most of this prevention effort has focused on the standard risk factors for heart disease. This study may give us better indicators of heart disease risk." The study also could yield more specific disease predictors; it will try to determine which factors best predict heart disease in men, women, and ethnic groups.

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Update on High Blood Pressure in Pregnancy Now Available

2000 Working Group Report on High Blood Pressure in Pregnancy

The NHLBI's National High Blood Pressure Education Program Coordinating Committee has issued new guidance for clinicians on high blood pressure in pregnancy. The 2000 Working Group Report on High Blood Pressure in Pregnancy clarifies how to monitor and treat pregnant women who have hypertension before pregnancy and those who develop hypertension during gestation. In addition to being available online, copies can be ordered through the NHLBI Information Center.

Hypertensive disorders occur in 6 to 8 percent of pregnancies and contribute significantly to serious complications for both mother and fetus. They account for nearly 15 percent of maternal deaths in the United States and can impair the mother's kidneys, liver, and central nervous system. Fetal complications are equally severe and include growth retardation and death (stillbirth).

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7 East Kids Page

Spotlight on Our Web Site

Clinical Cardiology Unit Develops Web Page for Children

The youngest patients of the NHLBI's 7 East Clinical Cardiology Unit now can get an online tour of what they can expect during their stay in Bethesda, Maryland. The colorful site introduces patients and their families to the admissions process, shows pictures of hospital rooms and the playroom, and accurately describes the medical procedures in a comforting, friendly way. Parents also will benefit from the Unit's general site, where they can get information on a variety of subjects including diagnostic tests, common cardiac medications, and services to make the patient's stay a little easier.

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New NHLBI Research Initiatives

From time to time, the NHLBI invites investigators to submit grant applications or contract proposals for specific research programs. We are currently soliciting applications for the programs described below. For a full details of these and other research initiatives, visit or the Web page that are linked each initiative number.

Ancillary Studies in Heart, Lung, and Blood Disease Trials

  • Initiative Number: RFA-HL-00-012
  • Applications are accepted for the following deadlines: December 11, 2000; March 9, June 11, September 10, December 10, 2001; and March 11, June 10, 2002.
  • Objective: To conduct mechanistic studies by utilizing patients and patient materials from clinical trials related to heart, lung, and blood diseases.

Biobehavioral Research for Effective Sleep

  • Initiative Number: PA-00-046
  • Applications are accepted for February 1, June 1, and October 1 deadlines each year.
  • Objective: To support research on sleep-related problems found in healthy and chronically ill individuals with acute and chronic sleep deprivation.

Cellular and Molecular Mechanisms of Primary Pulmonary Hypertension

  • Initiative Number: PA-00-043
  • Applications are accepted for February 1, June 1, and October 1 deadlines each year.
  • Objective: To promote research in primary pulmonary hypertension with an emphasis on understanding the disease mechanisms.

Functional Tissue Engineering for Heart, Vascular, Lung, Blood, and Sleep Disorders and Diseases

  • Initiative Number: PAR-01-006
  • Phase I and II applications applications are accepted for the following deadlines: March 13, 2001 and March 13, 2002 for Phase I and II applications. March 13, 2003 and March 12, 2004 deadlines are for Phase II applications only.
  • Objectives: To stimulate engineering of biological substitutes for damaged tissues and organs and to promote the development of novel tissue regeneration and remodeling approaches.

Genetic Aspects of Tuberculosis in the Lung

  • Initiative Number: RFA-HL-00-014
  • Applications are due on January 17, 2001.
  • Objective: To identify genes, or families of genes, that determine resistance and susceptibility to mycobacterial infection, virulence, latency, reactivation of disease and resistance to antituberculous drugs.

Genetic Modifiers of Single Gene Defect Diseases

  • Initiative Number: RFA-HL-01-001
  • Applications are due on February 20, 2001.
  • Objective: To identify and characterize genes responsible for differences in clinical progression and outcome of various diseases.

Mouse Models of Diabetic Complications Consortium

  • Initiative Number: RFA-DK-01-009
  • Applications are due on March 28, 2001.
  • Objective: To assemble a cross-disciplinary consortium to develop mouse models that closely mimic the human complications of diabetes.

Non-mouse Models of Diabetes Complications in Cardiovascular and Microvascular Diseases

  • Initiative Number: RFA-HL-01-010
  • Applications are due on March 21, 2001.
  • Objective: To accelerate the pace at which accurate and reproducible non-mouse animal models of diabetic vascular complications are developed.

Physical Activity and Obesity Across Chronic Diseases

  • Initiative Number: PA-01-017
  • Applications are due on
  • Objectives: To examine relationships between physical activity and obesity, to improve methodology of assessment of physical activity and energy balance, and to test intervention approaches that incorporate physical activity for obesity prevention or treatment related to chronic diseases.

SCOR: Molecular Medicine and Atherosclerosis

  • Initiative Number: RFA-HL-00-015
  • Applications are due on June 15, 2001.
  • Objective: To support molecular research of the etiology and pathophysiology of atherosclerosis.

Self-Management Strategies Across Chronic Diseases

  • Initiative Number: PA-00-109
  • Applications are accepted for February 1, June 1, and October 1 deadlines each year.
  • Objective: To expand research on established self-management interventions, such as those used in treating blood disorders, and understand their implications in treating other chronic diseases.

Stem Cell Plasticity in Hematopoietic and Non-hematopoietic Tissue

  • Initiative Number: RFA-HL-01-007
  • Applications are due on March 21, 2001.
  • Objective: To encourage research to document the extent to which stem cells that have the potential to form blood cells also may be able to form other cells (e.g., neural cells).

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