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 @ 12:37 PM
Ignite Modification Date:
2025-12-24 @ 12:37 PM
NCT ID:
NCT07251361
Eligibility Criteria:
Inclusion Criteria:
* Patients diagnosed with heart failure with preserved ejection fraction according to 2021 ESC guidelines for Heart Failure.
* Left ventricular ejection fraction (LVEF) \>40%, and/or evidence of structural and/or functional cardiac abnormality (diastolic dysfunction, elevated filling pressures, BMI\>30 kg/m2)
* Elevated natriuretic peptides (BNP ≥35 pg/mL or NT-proBNP ≥125 pg/mL)
* Stable symptomatic heart failure patients (New York Heart Association functional class II-III/IV) during the last month
Exclusion Criteria:
* Participation in cardiac rehabilitation within the past 12 months.
* Contraindications to physical exercise training.
* Alternative diagnoses that could explain symptoms of HF (dyspnea, fatigue), in the judgment of the cardiologist.
* Significant pulmonary disease, including primary pulmonary hypertension.
* Severe chronic lung disease, including COPD requiring home oxygen, chronic nebulizer therapy, long-term oral steroids, or hospitalization for decompensated pulmonary disease within the past 12 months.
* Hemoglobin \<10 g/dL.
* Body mass index (BMI) \>40 kg/m².
* Inability to perform a valid baseline cardiopulmonary exercise test
* Inability to comprehend study information or complete questionnaires (e.g., psychiatric disorder, dementia).
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07251361
Study Brief:
Protocol Section:
NCT07251361