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Heart Failure and Risk of Re-Admissions Determined by Abnormal REVEAL Parameters (HF-RADAR)

This study has been terminated.
(enrollment futility)
Sponsor:
Collaborators:
Central Bucks Specialists, LTD
Drexel University
The Valley Hospital
Saint Thomas Research Institute, LLC
Information provided by (Responsible Party):
Thomas Jefferson University
ClinicalTrials.gov Identifier:
NCT01357408
First received: May 18, 2011
Last updated: January 4, 2013
Last verified: January 2013
History of Changes
  Purpose

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.


Condition
Heart Failure

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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.

Resource links provided by NLM:

MedlinePlus related topics: Heart Failure
U.S. FDA Resources

Further study details as provided by Thomas Jefferson University:

Primary Outcome Measures:
  • Worsening HF symptoms or HF-related clinical events [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: May 2011
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01357408

Locations
United States, Pennsylvania
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Thomas Jefferson University
Central Bucks Specialists, LTD
Drexel University
The Valley Hospital
Saint Thomas Research Institute, LLC
  More Information

Additional Information:
Jefferson Coordinating Center for Clinical Research  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT01357408     History of Changes
Other Study ID Numbers: 080-18014-J66601
Study First Received: May 18, 2011
Last Updated: January 4, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Thomas Jefferson University:
without an indication for ICD or CRT
left ventricular function greater than or equal to 40%

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 23, 2013