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 @ 2:09 PM
Ignite Modification Date:
2025-12-24 @ 2:09 PM
NCT ID:
NCT06930495
Eligibility Criteria:
Inclusion Criteria:
Group 1: Patients with HFpEF
* Diagnosis of heart failure or clear heart failure hospitalization
* Stable ejection fraction \> 0.50
* Objective evidence of elevated left ventricular filling pressure by one of the following i) pulmonary capillary wedge pressure ≥25 mmHg during supine cardiopulmonary exercise testing or ii) a change in pulmonary capillary wedge pressure of \>15 mmHg during upright exercise
* Must be candidates for pharmacological incretin-based directed intensive weight loss therapies as part of their SOC
* BMI\>32kg/m2
* ≥45 years old
* Incretin naïve for 6 months
Group 2: Non-HFpEF controls
* Adults who do not have heart failure with preserved ejection fraction
* Age ≥ 18 years
Exclusion Criteria:
Group 1
* Prior history of reduced ejection fraction (\<50%)
* Infiltrative cardiomyopathy
* NYHA Class IV chronic heart failure
* Left bundle branch block
* Unstable coronary artery disease
* Uncontrolled arrhythmia
* CKD 4 or higher
* Currently taking incretin-based drugs (SGL2, GLP1)
* Severe valvular heart disease
* BMI \> 50kg/m2
* Other debilitating illness that would preclude participation
* Any contra-indication to MRI
* Any contra-indication to muscle biopsies.
Group 2
* Age \< 18 years
* BMI \> 50 kg/m2
* Atrial fibrillation with poorly controlled heart rate
* PDE5 inhibitor use
* Severe valvular disease
* Severe COPD
* CKD 4 or higher
* Currently taking incretin-based drugs (SGL2, GLP1)
* Any contra-indication to MRI
* Any contra-indication to muscle biopsies.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06930495
Study Brief:
Protocol Section:
NCT06930495