Heart Failure and Risk of Re-Admissions Determined by Abnormal REVEAL Parameters (NCT01357408) | Clinical Trial Compass
TerminatedNot Applicable
Heart Failure and Risk of Re-Admissions Determined by Abnormal REVEAL Parameters
Stopped: enrollment futility
United States40 participantsStarted 2011-05
Plain-language summary
The purpose of the Heart Failure and Risk of re-Admissions Determined by Abnormal REVEAL Parameters (HF RADAR) study is to evaluate the ability of cardiac rhythm (Cardiac Compass) data to predict future cardiac events in heart failure (HF) patients recently discharged after a hospitalization for heart failure who have or plan to have a implanted loop recorder (ILR), specifically, the Reveal XT device. The study will enroll 40 HF patients (with LV function ≥ 40%) admitted to an acute care facility (observation status or hospital stay) for heart failure who either have a Reveal XT device in place or plan to have the ILR device inserted for clinical indication within 14 days of discharge from the hospitalization. HF patients will be followed for 6 months. Device date will be captured during normal clinic visits and at 6 months.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Men and non-pregnant/non lactating women ≥ 18 years.
✓. Admission to hospital or observation unit for worsening heart failure.
✓. Has a Reveal XT device or has plans for a device implant for a clinical indication within 14 days of discharge.
✓. Ejection fraction ≥40% by echocardiogram within 6 months of enrollment
✓. Able to participate in the study for at least 6 months.
✓. Not currently enrolled in another study.
✓. Able to provide informed consent and complete scheduled study visits.
Exclusion criteria
✕. Has a clinical indication for a therapeutic cardiac device (pacemaker or defibrillator)
✕. History of permanent atrial fibrillation or atrial flutter.
✕. History of uncontrolled hypertension (high blood pressure)
What they're measuring
1
Worsening HF symptoms or HF-related clinical events