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

Heart Failure Clinical Trial

— HF-RADAR  

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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01357408
• Other study ID #: 080-18014-J66601
• Status: Terminated
• Phase: N/A
• First received: May 18, 2011
• Last updated: January 4, 2013
• Start date: May 2011

Study information

• Verified date: January 2013
• Source: Thomas Jefferson University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 40
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Heart Failure

Locations

Country	Name	City	State
United States	Thomas Jefferson University	Philadelphia	Pennsylvania

Sponsors (5)

Lead Sponsor	Collaborator
Thomas Jefferson University	Central Bucks Specialists, Ltd., Drexel University, Saint Thomas Research Institute, LLC, The Valley Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Worsening HF symptoms or HF-related clinical events		6 months	No