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 @ 10:12 PM
Ignite Modification Date:
2025-12-24 @ 10:12 PM
NCT ID:
NCT03550235
Eligibility Criteria:
Inclusion Criteria:
* Patient over 40 years of age, and under 80 years of age with unexplained effort dyspnea, able to pedal.
* Echocardiographic ejection fraction \> 50%
* NTproBNP \< 220 pg/ml in \< 75 years, and \< 450 pg/ml in ≥ 75 years
Exclusion Criteria:
* Patient with coronary, valve, hypertrophic, hypertensive, infiltrative, constrictive, or rhythmic, significant and/or progressive heart disease.
BMI \> 35 kg/m².
* Unstable patient (systolic blood pressure \< 90 mmHg, resting pulse \> 100 BPM) or clinically congested (edema of the lower limbs, crackling in the lungs).
* Patient with Pulmonary function testing (EFR) showing significant respiratory disease (FEV1/ vital capacity (CV) max \< 0.7, total lung capacities (CPT)\< LIN)
* Chronic renal failure with creatinine clearance \< 30 ml/min (MDRD) or dialysis
* Patient with anemia (Hb \< 12 g/dl)
* Patient with hypo or hyperthyroidism on thyreostimulating hormone (TSH) value
* Patient under justice safeguard measure or guardianship
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
85 Years
Study:
NCT03550235
Study Brief:
Protocol Section:
NCT03550235