Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:44 AM
Ignite Modification Date:
2025-12-25 @ 12:44 AM
NCT ID:
NCT01185067
Eligibility Criteria:
Inclusion Criteria:
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 Criteria:
* 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)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
50 Years
Study:
NCT01185067
Study Brief:
Protocol Section:
NCT01185067