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:
2025-12-24 @ 1:13 PM
Ignite Modification Date:
2025-12-24 @ 1:13 PM
NCT ID:
NCT01942395
Eligibility Criteria:
Inclusion Criteria:
* Symptoms and/or signs of HFPEF in the past 12 months
* Most recent LVEF ≥ 50% (contrast ventriculography, echocardiography, nuclear scintigraphy)
* Diastolic dysfunction on previous echocardiogram/catheterization or evidence of abnormal neurohormonal activation (B-type natriuretic peptide (BNP) ≥ 100 pg/ml)
* History of systemic hypertension
* Willing to adhere to provided diet
Exclusion Criteria:
* NYHA Class IV heart failure symptoms
* Hospitalization for decompensated HF within past one month
* Uncontrolled hypertension (seated SBP ≥ 180 or DBP ≥ 110) at rest, on current antihypertensive regimen
* Changes in medical regimen for heart disease or hypertension within past 1 month, except diuretic dose adjustment (within past 1 week)
* Previous LVEF \< 40%
* Primary exercise limitation due to severe pulmonary disease
* Uninterpretable echocardiographic windows
* Worse than moderate mitral or aortic stenosis or insufficiency.
* Baseline serum potassium level \> 5.0 mmol/L or prior history of potassium \> 6.0
* Serum calcium/phosphorus product \> 50 at baseline
* Severe renal insufficiency (current estimated GFR \< 30 ml/min)
* Severe anemia (Hgb \< 9 g/dL)
* Severely uncontrolled diabetes mellitus (Hgb A1C \> 10%)
* Non-hypertension related cause of HFPEF (e.g. amyloidosis, sarcoidosis, constrictive pericardial syndromes, primary hypertrophic or restrictive cardiomyopathy)
* Primary right ventricular failure
* 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
* Psychiatric disorder or dementia with potential to compromise dietary adherence
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
50 Years
Study:
NCT01942395
Study Brief:
Protocol Section:
NCT01942395