Search / Trial NCT00001534

Long Term Effects of Enalapril and Losartan on Genetic Heart Disease

Launched by NATIONAL HEART, LUNG, AND BLOOD INSTITUTE (NHLBI) · Nov 3, 1999

Trial Information

Current as of November 03, 2024

Completed

Keywords

Genetics Myocardial Ischemia Diastolic Dysfunction Renin Angiotensin System Hypertrophic Cardiomyopathy Left Ventricular (Lv) Hypertrophy

Description

Hypertrophic cardiomyopathy (HCM) is a genetic cardiac disease characterized by left ventricular (LV) hypertrophy. There is often associated LV diastolic dysfunction and myocardial ischemia. The severity of the LV hypertrophy, diastolic dysfunction, and myocardial ischemia are important determinants of clinical outcomes. Angiotensin II modulates cell growth and cardiac function. There is also increasing evidence that the renin-angiotensin system (RAS) may be present in cardiac cells, and the hypertrophic action of angiotensin II could therefore be mediated by circulating or locally produced...

Gender

ALL

Eligibility criteria

  • INCLUSION CRITERIA
  • HCM of either gender, aged 20-55 years.
  • Non-dilated LV (LVIDd less than 60 mm) with LV wall thickness of greater than or equal to 16 mm measured in any LV segment by NMR.
  • Non-obstructive HCM: A LV outflow gradient of less than or equal to 30 mm Hg gradient at rest and less than or equal to 55 mm Hg following isoproterenol infusion to a heart rate of greater than or equal to 120 beats per minute at cardiac catheterization.
  • New York Heart Association functional class I-III.
  • Patients who have participated in the previous toxicity study may be recruited for this study, if they wish.
  • Patients who have previously taken an ACE inhibitor or losartan could only be included in this study, if they have been off these drugs for a period of 6 months or longer.
  • EXCLUSION CRITERIA
  • Severe cardiac symptoms at rest (NYHA IV).
  • LV outflow tract gradient of greater than 30 mm Hg at rest or greater than 55 mm Hg following isoproterenol infusion to a heart rate of greater than or equal to 120 beats per minute at cardiac catheterization.
  • Systemic diseases (respiratory, neurologic, or locomotor) that prevent exercise testing, echocardiography or NMR, MUGA, thallium studies, and cardiac catheterization.
  • Coronary artery disease (greater than 50% arterial luminal narrowing of a major epicardial vessel) or congenital cardiovascular abnormalities (e.g. ASD, VSD, coronary anomalies).
  • Chronic atrial fibrillation.
  • Bleeding disorder (PTT greater than 35 sec, pro time greater than 14.7 sec, platelet count less than 154 k/mm3).
  • Anemia (Hb less than 12.7 g/dl in males and less than 11.0 g/dl in females); renal impairment (BUN greater than 22 mg/dl and serum creatinine greater than 1.4 mg/dl); K+ less than 3.3 mmol/l or greater than 5.1 mmol/l.
  • Hypertension: basal systolic and diastolic pressures of greater than 160 mm Hg or greater than 95 mm Hg, respectively on two occasions separated by one hour of rest.
  • Hypotension: basal sitting systolic arterial pressure less than 100 mm Hg confirmed 30 minutes later.
  • Must have ability to estimate LV wall thickness.
  • Radiographic evidence of overt cardiac failure (pulmonary edema on chest X-ray).
  • Negative urine pregnancy test.
  • Pregnant or lactating female patients.
  • Diminished LV systolic function (resting or exercise LV ejection fractions estimated by radionuclide angiography less than 50%).
  • Dependence on other cardioactive drugs such as diuretics, verapamil, B-blockers, or antiarrhythmic drugs to control symptoms and arrhythmias.
  • Negative HIV test.
  • Sensitivity to ACE inhibitor e.g. angioedema.
  • Must have ability to set up an outpatient monitoring system.

About National Heart, Lung, And Blood Institute (Nhlbi)

The National Heart, Lung, and Blood Institute (NHLBI) is a leading component of the National Institutes of Health (NIH), dedicated to advancing research and clinical trials focused on cardiovascular, pulmonary, and hematologic diseases. With a mission to improve public health through innovative research, the NHLBI supports a wide range of studies aimed at understanding, preventing, and treating heart and lung conditions. By collaborating with academic institutions, healthcare providers, and patient communities, the NHLBI strives to translate scientific discoveries into effective clinical practices, ultimately enhancing the quality of life for individuals affected by these critical health issues.

Locations

Bethesda, Maryland, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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