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 @ 10:17 PM
Ignite Modification Date:
2025-12-24 @ 10:17 PM
NCT ID:
NCT00799435
Eligibility Criteria:
Inclusion Criteria:
* Stable New York Heart Association (NYHA) Class II-IV heart failure symptoms for at least 4 weeks before study entry
* Diagnosis of diastolic heart failure with a normal ejection fraction
* Admitted to the hospital with a diagnosis of heart failure in the 12 months before study entry
* Type 2 diabetes
Exclusion Criteria:
* Unstable angina, heart attack, coronary artery bypass surgery, or angioplasty in the 3 months before study entry
* Angina with exertion
* Technically inadequate echocardiogram
* Atrial fibrillation or atrial flutter
* Severe valvular heart disease
* Significant kidney insufficiency (serum creatinine greater than 2.0 mg/dL or require hemodialysis)
* Conditions that may be associated with changes in markers of fibrosis or collagen turnover (e.g., ongoing or active rheumatological disease, requiring significant anti-inflammatory agents, immunosuppression, pulmonary fibrosis, active cancer)
* Significant history of active substance abuse
* Type 1 diabetes
* Type 2 diabetes requiring chronic insulin use before study entry
* Active thiazolidinedione (TZD) use, because TZDs have been shown to worsen volume retention and may exacerbate signs and/or symptoms of heart failure
* Pregnant or breastfeeding
* Hypertrophic cardiomyopathy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
30 Years
Study:
NCT00799435
Study Brief:
Protocol Section:
NCT00799435