Status:
COMPLETED
Ventricular-Vascular Coupling in Heart Failure
Lead Sponsor:
Brigham and Women's Hospital
Conditions:
Heart Failure With Preserved Ejection Fraction
Eligibility:
All Genders
18-80 years
Brief Summary
This study will test the hypothesis that increases in ventricular-vascular stiffness can be demonstrated by arterial tonometry and echocardiography in subjects with heart failure with preserved ejecti...
Detailed Description
The pathophysiologic mechanisms responsible for the development of heart failure in people with preserved ejection fraction (i.e. normal left ventricular function) remain poorly understood. One possib...
Eligibility Criteria
Inclusion
- Subjects with heart failure and preserved ejection fraction
- clinical signs of heart failure
- serum brain natriuretic peptide (BNP) \>100pg/mL
- NYHA functional class II-IV
- left ventricular ejection fraction(LVEF) \>=50% measured by echocardiography
- Non-diabetic subjects with hypertension
- treated or untreated essential hypertension
- LVEF \>=50% measured by echocardiography
- Diabetic subjects with hypertension
- Type 2 diabetes
- treated or untreated essential hypertension
- LVEF \>=50% measured by echocardiography
- Normotensive control subjects
- normal blood pressure (i.e. \< 140/90 mmHg)
- LVEF \>=50% measured by echocardiography
Exclusion
- Subjects with heart failure and preserved ejection fraction
- atrial fibrillation
- symptoms of angina or a myocardial infarction (MI) within 6 months
- known significant coronary artery disease (CAD) (stenosis \> 70%)
- significant valvular heart disease
- restrictive/constrictive heart disease
- inability to lie flat for procedure (estimated duration 1 hour)
- Non-diabetic subjects with hypertension
- atrial fibrillation
- symptoms of angina or a myocardial infarction (MI) within 6 months
- known significant coronary artery disease (CAD) (stenosis \> 70%)
- significant valvular heart disease
- restrictive/constrictive heart disease
- inability to lie flat for procedure (estimated duration 1 hour)
- prior history of heart failure or unexplained dyspnea
- Diabetic subjects with hypertension
- atrial fibrillation
- symptoms of angina or a myocardial infarction (MI) within 6 months
- known significant coronary artery disease (CAD) (stenosis \> 70%)
- significant valvular heart disease
- restrictive/constrictive heart disease
- inability to lie flat for procedure (estimated duration 1 hour)
- prior history of heart failure or unexplained dyspnea
- Normotensive control subjects
- prior history of structural heart disease or ventricular hypertrophy
- treatment with HMG-Co(A)reductase inhibitors (statins)
- anti-hypertensive medications
- cigarette smoking
- cocaine use
- excessive alcohol intake
Key Trial Info
Start Date :
January 1 2004
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 1 2007
Estimated Enrollment :
53 Patients enrolled
Trial Details
Trial ID
NCT00207220
Start Date
January 1 2004
End Date
January 1 2007
Last Update
November 9 2007
Active Locations (1)
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1
Brigham & Women's Hospital
Boston, Massachusetts, United States, 02115