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 @ 5:58 PM
Ignite Modification Date:
2025-12-24 @ 5:58 PM
NCT ID:
NCT06978868
Eligibility Criteria:
Inclusion criteria:
* NYHA class II or III, clinically stable in the previous three months
* Females and males, age \>50 years
* Left ventricular EF \>50%, and at least 2 of the following: left atrial volume index (LAVI ≥34ml/m2) or E/e' \>9 or interventricular septal thickness \>12mm or pulmonary arterial pressure \>35mmHg (noninvasive measurement) for HFpEF as recommended according to the ESC-HF-guidelines.
* Stable on standard HF medication according to the ESC-HF guidelines in the last 4 weeks
Exclusion criteria:
* Major cardiovascular event or procedure such as myocardial infarction, percutaneous coronary intervention (PCI), aortocoronary bypass operation in the previous 3 months.
* Patients who have an indication for dual platelet inhibition
* Stroke
* Patients with mechanical heart valves or implanted cardiac devices
* Pulmonary embolism or deep vein thrombosis
* Patients with altered or reduced sweat function, such as in autoimmune diseases, spinal cord injuries or Fabry disease
* Symptomatic hypotension regardless of the measured value and those with BP systolic \<110 mm Hg
* Patients on oral anticoagulation for other reasons than atrial fibrillation
* Uncontrolled diabetes mellitus (HbA1c\>8%), severe renal dysfunction, GFR\<30ml/min) or pulmonary disease (COPD GOLD ≥3)
* Primary muscle disorder (e.g., muscular dystrophies)
* Neurological disease (e.g., Dementia or Parkinson syndrome)
* Right ventricular dysfunction or uncontrolled arrhythmias
* Any condition that in the opinion of the investigator could prohibit performance of 6MWT
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
50 Years
Study:
NCT06978868
Study Brief:
Protocol Section:
NCT06978868