Heart Failure and Risk of Re-Admissions Determined by Abnormal REVEAL Parameters

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.

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01357408

Acronym

HF-RADAR

Enrollment

Registered

2011-05-20

Start date

2011-05-31

Completion date

Unknown

Last updated

2013-01-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure

Keywords

without an indication for ICD or CRT, left ventricular function greater than or equal to 40%

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Worsening HF symptoms or HF-related clinical events	6 months

Countries

United States

Outcome results