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 @ 4:23 AM
Ignite Modification Date:
2025-12-25 @ 4:23 AM
NCT ID:
NCT06514820
Eligibility Criteria:
Inclusion Criteria:
1. Signs and symptoms of HF according to the Europeans Society of Cardiology guideline.
2. LV ejection fraction ≥40%.
3. HFA-PEFF score ≥5 or HFA-PEFF score 2-4 in combination with positive stress test (Figure 1).
4. \>18 years of age
5. In sinus rhythm
6. Able to perform a bicycle exercise test
7. Willing to sign informed consent
Exclusion Criteria:
1. Body weight \>140 kg
2. Atrial fibrillation or other significant arrhythmia during the assessment
3. Contraindications for CMR (e.g. claustrophobia, implanted cardiac devices)
4. Myocardial infarction, percutaneous coronary intervention or coronary artery bypass graft \<3 months or untreated severe obstructive coronary artery stenosis
5. More than moderate left-sided valve disease.
6. Complex congenital heart disease.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06514820
Study Brief:
Protocol Section:
NCT06514820