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

NCT01357408 | Terminated

• 1 other identifier: 080-18014-J66601
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Worsening HF symptoms or HF-related clinical events

  6 months

Study Arms (1)

REVEAL XT device

Subjects implanted at time of admission for HF or to be implanted within 14 days of discharge from HF hospitalization for clinical indications\>

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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)
• Has a previously implanted cardiac device (pacemaker or defibrillator) in place.
• Stage IV or V chronic renal dysfunction (estimated GFR \<25 ml/min per 1.73 m2)
• End-stage (Stage D) HF, including chronic ionotropic drugs infusions or left ventricular assist device
• Waiting on the transplant list as an UNOS status 1A or 1B patient

Sponsors & Collaborators

• Thomas Jefferson University: lead
• Central Bucks Specialists, Ltd.: collaborator
• Drexel University: collaborator
• The Valley Hospital: collaborator
• Saint Thomas Research Institute, LLC: collaborator

Study Sites (1)

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Conditions

Heart Failure; Creatine deficiency, X-linked

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2011
• First Posted: May 20, 2011
• Study Start: May 1, 2011
• Primary Completion: December 1, 2012
• Last Updated: January 7, 2013

Record last verified: 2013-01

Locations

US (1)