Status:
COMPLETED
Physiological Effects of Grape Seed Extract in Diastolic Heart Failure
Lead Sponsor:
University of Michigan
Conditions:
Diastolic Heart Failure
Hypertensive Heart Disease
Eligibility:
All Genders
50+ years
Phase:
PHASE1
Brief Summary
Diastolic heart failure (also known as "heart failure with normal ejection fraction" or "heart failure with preserved ejection fraction") occurs even though the heart muscle's pumping function is norm...
Eligibility Criteria
Inclusion
- Inclusion:
- Signs and symptoms of heart failure
- Left ventricular ejection fraction ≥ 50% (contrast ventriculography, echocardiography, nuclear scintigraphy, MRI or CT imaging)
- Diastolic dysfunction on previous echocardiogram/catheterization, or indeterminate diastolic function with supporting evidence of heart failure (HF) (as per European Society of Cardiology guidelines)
- History of systemic hypertension
- Age ≥ 50 years
- Willing to adhere to prescribed course of supplementation
- Informed consent
Exclusion
- Daily intake of antioxidant supplements or vitamins beyond that provided in a standard daily multivitamin (e.g. high-dose vitamin E or vitamin C)
- NYHA Class IV heart failure symptoms (except during previous hospitalization)
- Hospitalization for decompensated heart failure within past one month
- Severely uncontrolled hypertension (SBP ≥ 180 and.or DBP ≥ 100 at rest, on current antihypertensive regimen
- Uncontrolled diabetes mellitus (hemoglobin A1C \> 9%)
- Severe renal (estimated GFR \< 30 ml/min) or hepatic disease/failure
- Severe anemia (Hgb \< 9)
- Primary exercise limitation due to severe pulmonary disease
- Unacceptably poor echocardiographic images for analysis
- Worse than moderate mitral or aortic stenosis or insufficiency.
- Non-hypertensive cause of HFpEF (e.g. valvular disease, congenital heart disease, amyloidosis, sarcoidosis, constrictive pericardial syndromes)
- Myocardial infarction or unstable angina, including new or worsening anginal syndrome, within the past three months
- Uncontrolled arrhythmia (including non rate-controlled atrial fibrillation)
- Terminal illness expected to result in death within six months or active solid-organ cancer
- Psychiatric disorder (or dementia) with potential to compromise adherence
- Changes in medical regimen for heart disease or hypertension within past 1 month (except diuretic dose adjustment)
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 24 2014
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT01185067
Start Date
October 1 2010
End Date
February 24 2014
Last Update
June 6 2017
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Michigan
Ann Arbor, Michigan, United States, 48109