Status:
COMPLETED
The Role of Heart Stiff and Weak Atrium on Exercise Capacity in Patients With Hypertrophic Cardiomyopathy
Lead Sponsor:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Cardiomyopathy, Hypertrophic
Eligibility:
All Genders
Brief Summary
This study will examine how heart stiffness and a weak atrium affect exercise capacity and symptoms in patients with hypertrophic cardiomyopathy (HCM). The atrium is the booster pumping chamber of the...
Detailed Description
Primary hypertrophic cardiomyopathy (HCM) is a genetic cardiac disease characterized by thickening (hypertrophy) of the left ventricular (LV) wall, dyspnea and/or fatigue in the setting of a normal or...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA - HCM Patients:
- HCM defined as maximal LV wall thickness by echocardiography greater than 13mm in the absence of other causes of LVH or greater than 15mm asymmetrical LV wall thickness if there is a history of mild hypertension (defined as systolic less than 160mmHg and diastolic less than 100mHg) controlled for greater than 6 months
- Non-obstructive HCM
- Age greater than or equal to 21 years.
- Patients with LV obstruction treated by LV myotomy and myectomy or percutaneous septal alcohol ablation that meet inclusion criteria are eligible for this study.
- EXCLUSION CRITERIA - HCM Patients:
- LV outflow obstruction noted during Doppler echocardiography at rest or with Valsalva maneuver defined as instantaneous peak gradient greater than 30 mmHg
- Hemodynamically significant valvular disorders, history of significant coronary obstruction (greater than 50% in any single artery), angina symptoms, myocardial ischemia on an imaging stress test or evidence of prior myocardial infarction. Patients older than 40 years of age with effort induced anginal symptoms typical of coronary insufficiency and a coronary distribution of myocardial ischemia on an imaging stress test will be considered for the study if coronary angiography rules out significant obstructive coronary disease.
- Chronic atrial fibrillation
- Cardiac pacemaker or other metallic implant unsafe for MRI
- Uncontrolled hypertension
- Dependence on a beta blocker that cannot be withdrawn
- Dependence on a calcium blocker that cannot be withdrawn
- Current use of digoxin
- History of digitalis intolerance
- Renal failure
- Diabetes mellitus
- Pregnancy or lactation
- Failure to indicate effective method of birth control measures if female patient is of childbearing age.
- Inability to exercise or disease states likely to result in impaired exercise capacity (such as pulmonary, hematological and musculoskeletal disorders)
- Echocardiographic images of insufficient quality, even after administration of contrast agent, for volumetric analysis.
- Inability to provide informed consent
Exclusion
Key Trial Info
Start Date :
December 1 2003
Trial Type :
OBSERVATIONAL
End Date :
March 1 2005
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00074880
Start Date
December 1 2003
End Date
March 1 2005
Last Update
March 4 2008
Active Locations (1)
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1
National Heart, Lung and Blood Institute (NHLBI)
Bethesda, Maryland, United States, 20892