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:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-26 @ 3:14 PM
NCT ID:
NCT07422961
Eligibility Criteria:
Inclusion Criteria:
* Postmenopausal women under 70 years of age (absence of menstruation for 12 consecutive months and estradiol \< 20 pg/mL and/or FSH \> 40 mIU/mL), presenting with unexplained exertional dyspnea.
* COVID-19 vaccination.
* Echocardiographic ejection fraction \> 50% and NT-proBNP \< 220 pg/mL.
* Women in sinus rhythm or with paroxysmal or permanent atrial fibrillation.
* Women considered physically inactive according to WHO recommendations (150 minutes of moderate-intensity endurance activity per week, or at least 75 minutes of vigorous-intensity endurance activity, or an equivalent combination of moderate- and vigorous-intensity activity.
Exclusion Criteria:
* Women with significant coronary heart disease, severe valvular disease (grade III or IV/IV), significant hypertrophic or hypertensive heart disease (LVH with wall thickness ≥ 13 mm), infiltrative disease (amyloidosis, Fabry disease, etc.), constrictive disease, or significant and/or progressive arrhythmic disease (ventricular arrhythmia).
* Women with significant obesity (BMI \> 30 kg/m²).
* Unstable women (systolic blood pressure \< 100 mmHg, resting heart rate \> 100 bpm) or women with clinical congestion (cardiac-related lower limb edema, pulmonary crackles).
* Women with pulmonary function tests indicating significant respiratory disease (FEV₁/FVC \< 0.7, TLC \< LLN).
* Women with chronic renal failure with creatinine clearance \< 30 mL/min (MDRD) or on dialysis.
* Women with anemia (Hb \< 12 g/dL).
* Women with uncontrolled hypo- or hyperthyroidism (abnormal TSH).
* Women who have undergone left breast augmentation (implant).
* Women under legal guardianship or conservatorship.
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
40 Years
Maximum Age:
70 Years
Study:
NCT07422961
Study Brief:
Protocol Section:
NCT07422961