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 @ 7:03 PM
Ignite Modification Date:
2025-12-24 @ 7:03 PM
NCT ID:
NCT04847557
Eligibility Criteria:
Inclusion Criteria:
* Have a diagnosis of stable heart failure (NYHA class II-IV) and left ventricular ejection fraction (LVEF) ≥50%
* Elevated NT-proBNP (N-terminal pro B-type natriuretic peptide) \> 200 picogram/milliliter (pg/ml) for participants without atrial fibrillation (AF), or \>600 pg/ml for participants with AF, Structural heart disease (Left atrial enlargement) or Elevated left ventricular filling pressure
* Estimated glomerular filtration rate (eGFR) \<70 milliliter (ml)/minute (min)/1.73m² at screening, or HF decompensation within 12 months of screening,
* Stable dose of heart failure medications within 4 weeks of screening
* Body mass index (BMI) ≥30 kilograms per meter squared (kg/m²)
* 6MWD 100-425 meters
* KCCQ CSS ≤80
Exclusion Criteria:
* Have had a major cardiovascular event within the last 90 days of screening
* Have had acute decompensated heart failure within 4 weeks of screening
* Have non cardiac causes of functional impairment such as pulmonary arterial hypertension (PAH), severe chronic obstructive pulmonary disease (COPD), anemia, thyroid disease, musculoskeletal disease or orthopedic conditions
* Presence of cardiac amyloidosis, cardiac accumulation disease, cardiomyopathy and severe valvular heart disease
* HbA1c ≥9.5% or uncontrolled diabetes
* History of proliferative diabetic retinopathy or diabetic maculopathy
* Have a history of pancreatitis
* eGFR \<15 mL/min/1.73 m² or requiring dialysis at screening
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Study:
NCT04847557
Study Brief:
Protocol Section:
NCT04847557