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 @ 6:52 PM
Ignite Modification Date:
2025-12-24 @ 6:52 PM
NCT ID:
NCT00400257
Eligibility Criteria:
Inclusion Criteria:
1. Age ≥60 years
2. Have been insured with HBA for 12 months or longer (Protocol amended to remove this criteria and allow enrollment of the general public)
3. Subjects at high-risk of subsequent development of heart failure; comprising at least one of:
* Prior myocardial infarction (MI) without known left ventricular (LV) dysfunction
* Current active ischemic heart disease
* Prior Cerebrovascular Accident (CVA)
* Known valvular heart disease without known LV dysfunction
* Atrial fibrillation
* Ventricular arrhythmia resulting in syncope or pre-syncope (protocol amended to remove this entry criteria)
* Treated hypertension, of at least 2 years duration
* Treated Diabetes mellitus, of at least 2 years duration
* Estimated Glomerular Filtration Rate (eGFR) \<50ml/min
Exclusion Criteria:
1. Known systolic or diastolic heart failure
2. Symptoms suggestive of current heart failure. (protocol amended to remove this criteria)
3. LV systolic or diastolic dysfunction on echocardiography or other objective imaging modality.
4. Medications for treatment of heart failure such as ACE inhibitors, angiotensin receptor blockers (ARBs), beta-blockers or aldosterone antagonists. Use of such medications for approved indications such as hypertension, post-MI management (without known LV dysfunction) or for diabetic nephropathy is permitted. (protocol amended to remove this criteria)
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
60 Years
Study:
NCT00400257
Study Brief:
Protocol Section:
NCT00400257