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 @ 4:12 AM
Ignite Modification Date:
2025-12-25 @ 4:12 AM
NCT ID:
NCT01589120
Eligibility Criteria:
Inclusion Criteria:
1. A diagnosis of advanced heart failure as defined by ALL THREE of the following:
• New York Heart Association Class III or IV (NYHA III or IV) (III: marked limitation in activity due to symptoms, even during less-than-ordinary activity; IV: severe limitations, experiences symptoms while at rest).
AND
* Hospitalization for heart failure within the last six months. AND
* Age greater than or equal to 65.
2. Additionally ONE of the following must be met:
* According to the attending physician's best judgment the patient's survival is limited to 2 years but may very well be less than 1 year (i.e. the physician would not be surprised if the patient died within one year from any cause) OR
* Three heart failure hospitalizations in the last year OR
* One of the following:
* Two Systolic Blood Pressures \< 90 within the last 6 months in the ambulatory setting
* Na \< 130 within the last 6 months
* NTproBNP \> 3,000
* EGFR \< 35
* High diuretic use (160 mg po Lasix or 100 mg po torsemide or equivalent total daily dose)
Exclusion Criteria:
* New patient
* A transplant or mechanical circulatory support candidate
* Major psychiatric illness as determined by the attending that would make this study inappropriate.
* Any patient that has been excluded for transplant or mechanical circulatory support due to psychological or psychiatric co-morbidities.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
65 Years
Study:
NCT01589120
Study Brief:
Protocol Section:
NCT01589120