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 @ 9:29 PM
Ignite Modification Date:
2025-12-24 @ 9:29 PM
NCT ID:
NCT00171132
Eligibility Criteria:
Inclusion Criteria:
* Body mass index (BMI) must be ≥ 27 and \< 35
* Symptoms of impaired exercise capacity (e.g. who report shortness of breath on exertion when questioned) reported at Visit 1 or patients who have a history of shortness of breath which improved under diuretic therapy
* LV ejection fraction must be \> 45% measured by echocardiography at Visit 2.
* Impaired exercise capacity measured by VO2max at Visit 4:
VO2max \>14 and \< 22 ml ⋅kg-1 ⋅min-1
Exclusion Criteria:
* Mean sitting diastolic blood pressure (MSDBP) ≥ 110 mmHg and/or Mean sitting systolic blood pressure (MSSBP) ≥ 180 mmHg
* LVEF ≤ 45 %
* Inability to completely discontinue all previous antihypertensive medications safely for the duration of the study
* Heavy smokers (\>20 cigarettes/day)
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT00171132
Study Brief:
Protocol Section:
NCT00171132