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 @ 4:49 AM
Ignite Modification Date:
2025-12-25 @ 4:49 AM
NCT ID:
NCT01691118
Eligibility Criteria:
Inclusion Criteria:
* Untreated hypertension: systolic BP ≥ 140 or diastolic BP ≥ 90 mmHg or Treated hypertension
* Current heart failure symptoms with NYHA class II
* Evidence of diastolic dysfunction showing any 2 of the following:
E/E' \> 10, LV posterior wall thickness \> 11 mm, BNP level \> 40 pg/mL
Exclusion Criteria:
* Planned cardiac surgery or planned major non-cardiac surgery within the study period
* Stroke or coronary revascularization in the past 6 months
* LV ejection fraction \< 50%
* Hypertrophic or restrictive cardiomyopathy, moderate or severe valve disease, constrictive pericarditis
* Atrial fibrillation with a heart rate \> 120/min
* Sitting systolic BP \< 100 mmHg
* Sitting systolic BP \> 160 mmHg or diastolic BP \> 95 mmHg despite antihypertensive therapy
* Significant renal disease manifested by serum creatinine \> 2.5 mg/dL
* Clinically significant pulmonary disease, coronary artery disease
* A diagnosis of cancer (other than superficial squamous or basal cell skin cancer) in the past 3 years or current treatment for the active cancer
* Female of child-bearing potential who do not use adequate contraception and women who are pregnant or breast-feeding
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
80 Years
Study:
NCT01691118
Study Brief:
Protocol Section:
NCT01691118