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 @ 4:51 PM
Ignite Modification Date:
2025-12-24 @ 4:51 PM
NCT ID:
NCT00378950
Eligibility Criteria:
Inclusion Criteria:
* Clinical diagnosis of HF
* Currently prescribed a Loop diuretic medication
* At least one of the following findings:
1. Chest x-ray consistent with HF (current or past x-ray with probable or definite pulmonary edema)
2. Reduced ejection fraction on echocardiogram (ECHO), multiple gate acquisition scan (MUGA), or cardiac catheterization (less than 50%)
3. Left ventricular hypertrophy (LVH) or diastolic filling pattern on ECHO
4. Elevated B-type natriuretic peptide
* Currently experiencing New York Heart Association Class II-IV symptoms or has experienced these symptoms in the 6 months prior to study entry
* Has a working telephone
* Speaks English or Spanish
Exclusion Criteria:
* Patients will be ineligible if they meet ONE the following criteria:
1. Sight - Inability to see printed educational material well enough to utilize it
2. Cognition - Moderate to severe dementia (If medical notes state "Severe Dementia" or as determined by administering the study's cognitive screener)
3. Surgery -Valuvular disease rated as severe (mitral stenosis, aortic stenosis or aortic regurgitation) or valuvular surgery planned within a year (i.e., bypass, angioplasty, valve replacement, heart transplant)
4. Terminal Illness - Possessing a terminal illness with prognosis of 1 year or less
5. Dialysis - Currently on dialysis or anticipated to start dialysis within 1 year
6. Oxygen Dependant - Using concentrate oxygen intermittent or continuously for COPD
7. Management of Care - Not able to control medications
8. Other Studies -Patient enrolled (past or present) in another study where intervention status would interfere with pure outcome of this or other study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Study:
NCT00378950
Study Brief:
Protocol Section:
NCT00378950