Clinical trial NCT01357408: Heart Failure and Risk of Re-Admissions Determined by Abnormal REVEAL Parameters
Official title: Phase 4 Registry Study Will 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.
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Heart Failure
Keywords: without an indication for ICD or CRT
left ventricular function greater than or equal to 40%
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
Collaborators: name: Central Bucks Specialists, Ltd.
name: Drexel University
name: The Valley Hospital
name: Saint Thomas Research Institute, LLC
First posted: 2011-05-20
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief 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.


Eligibility criteria: Inclusion Criteria:

1. Men and non-pregnant/non lactating women ≥ 18 years.
2. Admission to hospital or observation unit for worsening heart failure.
3. Has a Reveal XT device or has plans for a device implant for a clinical indication within 14 days of discharge.
4. Ejection fraction ≥40% by echocardiogram within 6 months of enrollment
5. Able to participate in the study for at least 6 months.
6. Not currently enrolled in another study.
7. Able to provide informed consent and complete scheduled study visits.

Exclusion Criteria:

1. Has a clinical indication for a therapeutic cardiac device (pacemaker or defibrillator)
2. History of permanent atrial fibrillation or atrial flutter.
3. History of uncontrolled hypertension (high blood pressure)
4. Has a previously implanted cardiac device (pacemaker or defibrillator) in place.
5. Stage IV or V chronic renal dysfunction (estimated GFR \<25 ml/min per 1.73 m2)
6. End-stage (Stage D) HF, including chronic ionotropic drugs infusions or left ventricular assist device
7. Waiting on the transplant list as an UNOS status 1A or 1B patient

Primary outcomes:
measure: Worsening HF symptoms or HF-related clinical events
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
Study officials:
References: