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 @ 2:38 AM
Ignite Modification Date:
2025-12-25 @ 2:38 AM
NCT ID:
NCT02779634
Eligibility Criteria:
Inclusion Criteria:
* Typical signs and symptoms of congestive heart failure (CHF) (New York Association Class 2-4).
* Normal ejection fraction on echocardiography (EF ≥50%).
* Evidence of diastolic dysfunction on non-invasive imaging (E:e' \> 15 or e:e' \> 8 with other measures of diastolic dysfunction such as e/a \< 0.5 with elevated deceleration time or left atrial volume index \> 40 cc/m2 or presence of elevated left ventricular mass index or elevated pulmonary pressures).
* Stable medical therapy for 4 weeks prior to randomization
Exclusion Criteria:
* Chronic atrial fibrillation.
* Acute coronary syndrome or coronary revascularization within 60 days.
* Clinically significant valvular disease.
* Known infiltrative cardiomyopathy (e.g. amyloidosis), hypertrophic cardiomyopathy or chronic pericardial disease.
* Inability/refusal to provide informed consent
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
50 Years
Study:
NCT02779634
Study Brief:
Protocol Section:
NCT02779634