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 @ 12:33 AM
Ignite Modification Date:
2025-12-25 @ 12:33 AM
NCT ID:
NCT05562167
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of heart failure with reduced ejection fraction; New York Heart Association (NYHA) Class II-III; Ejection fraction less than 45% as determined on an imaging study within 3 months of enrollment.
* Stable medical therapy, defined by no addition or removal (or change of more than 100 percent) of the following: beta-adrenergic blockade and angiotensin converting enzyme (ACE) inhibitors or angiotensin receptor blocker (ARB or aldosterone antagonists) or ARNI (ARB + sacubitril) for 60 days.
Exclusion Criteria:
* Vulnerable populations as defined by the U.S. Department of Health and Human Services; prisoners and children will be excluded from this study
* Pharmacologic, organic nitrate therapy within the last 3 months
* Major orthopedic, psychiatric, neurological, or other conditions that would hinder the ability to complete the exercise tests
* Estimated glomerular filtration rate less than 45 mL/min on screening clinical laboratories
* Systolic blood pressure less than 90mmHg or greater than 180mmHg at screening; Diastolic blood pressure less than 40mmHg or greater than 100mmHg at screening
* Previous adverse reaction to nitrate necessitating withdrawal of therapy; Treatment with phosphodiesterase inhibitors within the last 3 months (patient must also be willing to not take them for the duration of the trial)
* Ejection fraction greater than or equal to 45%
* Primary hypertrophic cardiomyopathy; Infiltrative cardiomyopathy (e.g., amyloid); Active myocarditis; Complex congenital heart disease;
* Active collagen vascular disease;
* Percutaneous coronary intervention, new bi-ventricular pacing, or coronary artery bypass grafting within the past 3 months
* Valvular heart disease with severe regurgitation or stenosis of any valve
* Acute or chronic severe liver disease as evidenced by encephalopathy or variceal bleeding
* Terminal disease (other than heart failure) with expected survival less than 1 y
* Enrollment in another therapeutic trial during the period of the study
* Pregnant women; Postmenopausal women taking exogenous estrogen replacement therapy
* Patients requiring exogenous oxygen at rest or during exercise
* Patients with active angina or ischemia due to epicardial coronary disease
* Patients taking xanthine oxidase inhibitors will be excluded
* Individuals taking proton pump inhibitors, antacids will be asked to hold these medications for the duration of the study if approved by his/her physician.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
19 Years
Maximum Age:
79 Years
Study:
NCT05562167
Study Brief:
Protocol Section:
NCT05562167