PARTNERS HF: Program to Access and Review Trending Information and Evaluate Correlation to Symptoms in Patients With Heart Failure

NCT00279955 | Completed Results

• 1 other identifier: 235
• Study Type: observational
• Target: 1,024
• Locations: 1 country
• Sites: 93

Brief Summary

The purpose of this study is to determine the value of diagnostic data obtained from Medtronic implantable cardioverter defibrillators (ICDs) with cardiac resynchronization therapy (CRT) to evaluate cardiovascular and heart failure related adverse events and health care utilization.

Conditions

Heart Failure, Congestive

Keywords

Heart Failure, Congestive; Implantable Cardioverter-Defibrillators

Outcome Measures

Primary Outcomes (1)

• Occurrence of Heart Failure (HF) Related Adverse Event (AE)

  Number of participates with HF realted adverse event will be reported. Time to the first HF related Adverse event in the "Follow-up Period" from the 6-month visit to the 12-month visit is compared between two risk groups. The goal was to test if there is a significant difference in time to first HF-related adverse event between two groups. A heart failure related (HF-related) adverse event is defined as an adverse event that results in a subject's worsening HF or related to the heart's inability to meet the metabolic demands of the body.

  From 6 month to the 12 month visit

Secondary Outcomes (2)

• Occurrence of Heart Failure (HF) Related Healthcare Utilization (HU)

  6 month to the 12 month visit

• Occurrence of Heart Failure (HF) Related Pulmonary Congestion Event (PCE)

  6 month to the 12 month visit

Interventions

Cardiac Resynchronization Therapy Device DEVICE

Patients with an ICD indication, a CRT indication and symptomatic heart failure who are implanted with a Cardiac Resynchronization Therapy Device.

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

Patients receiving a specified Medtronic Implantable Cardiac Resynchronization Therapy Defibrillator device where informed consent and/or authorization to use and disclose health information permission has been granted.

You may qualify if:

• Patients who meet the ICD indications
• Patients with Class III or IV heart failure.
• Patients receiving or who received a Medtronic CRT ICD within the previous 3 months.
• Patient must sign and date informed consent, and be 18 years of age or greater.
• Patient must be available for follow up visits, and be willing and able to comply with study protocol.

You may not qualify if:

• Patient with acute myocardial infarction (MI), coronary artery bypass graft surgery (CABG) or percutaneous coronary angioplasty (PTCA)/stent within the last month.
• Patient with a mechanical right heart valve.
• Patient with chronic (permanent) atrial arrhythmias.
• Patient with life expectancy of less than 12 months.
• Patient with status post heart transplant
• Patient undergoing kidney dialysis
• Patients enrolled in a concurrent study that may confound the results of the study.

Sponsors & Collaborators

• Medtronic Cardiac Rhythm and Heart Failure: lead
• Medtronic: collaborator

Study Sites (93)

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Huntsville, Alabama, United States

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Phoenix, Arizona, United States

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Scottsdale, Arizona, United States

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Little Rock, Arkansas, United States

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Loma Linda, California, United States

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San Diego, California, United States

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Denver, Colorado, United States

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Guilford, Connecticut, United States

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Bradenton, Florida, United States

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Fort Lauderdale, Florida, United States

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Key Largo, Florida, United States

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Melbourne, Florida, United States

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Miami, Florida, United States

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Orlando, Florida, United States

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Palm Beach Gardens, Florida, United States

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Pensacola, Florida, United States

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Safety Harbor, Florida, United States

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Tallahassee, Florida, United States

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Tampa, Florida, United States

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Winter Park, Florida, United States

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Atlanta, Georgia, United States

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Augusta, Georgia, United States

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Honolulu, Hawaii, United States

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Evanston, Illinois, United States

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Maywood, Illinois, United States

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Merrionette Park, Illinois, United States

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Rockford, Illinois, United States

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Springfield, Illinois, United States

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Winfield, Illinois, United States

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Topeka, Kansas, United States

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Wichita, Kansas, United States

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Edgewood, Kentucky, United States

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Florence, Kentucky, United States

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Louisville, Kentucky, United States

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Covington, Louisiana, United States

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Monroe, Louisiana, United States

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Portland, Maine, United States

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Salisbury, Maryland, United States

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Takoma Park, Maryland, United States

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Grand Rapids, Michigan, United States

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Marquette, Michigan, United States

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Petoskey, Michigan, United States

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Traverse City, Michigan, United States

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Minneapolis, Minnesota, United States

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Saint Cloud, Minnesota, United States

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St Louis, Missouri, United States

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Missoula, Montana, United States

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Las Vegas, Nevada, United States

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Manchester, New Hampshire, United States

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Cherryhill, New Jersey, United States

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Ridgewood, New Jersey, United States

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Sewell, New Jersey, United States

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New York, New York, United States

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The Bronx, New York, United States

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West Islip, New York, United States

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Williamsville, New York, United States

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Charlotte, North Carolina, United States

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Durham, North Carolina, United States

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Greensboro, North Carolina, United States

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Raleigh, North Carolina, United States

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Bismarck, North Dakota, United States

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Fargo, North Dakota, United States

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Cincinnati, Ohio, United States

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Columbus, Ohio, United States

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Dayton, Ohio, United States

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Elyria, Ohio, United States

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Lakewood, Ohio, United States

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Mayfield Heights, Ohio, United States

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Westlake, Ohio, United States

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Medford, Oregon, United States

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Camp Hill, Pennsylvania, United States

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Erie, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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Wormleysburg, Pennsylvania, United States

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York, Pennsylvania, United States

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Pawtucket, Rhode Island, United States

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Providence, Rhode Island, United States

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Columbia, South Carolina, United States

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Spartanburg, South Carolina, United States

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Sioux Falls, South Dakota, United States

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Knoxville, Tennessee, United States

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Nashville, Tennessee, United States

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Fairfax, Texas, United States

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Fort Worth, Texas, United States

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Lubbock, Texas, United States

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Burlington, Vermont, United States

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Lynchburg, Virginia, United States

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Norfolk, Virginia, United States

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Richmond, Virginia, United States

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Kirkland, Washington, United States

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Green Bay, Wisconsin, United States

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Madison, Wisconsin, United States

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Related Publications (2)

• Whellan DJ, Ousdigian KT, Al-Khatib SM, Pu W, Sarkar S, Porter CB, Pavri BB, O'Connor CM; PARTNERS Study Investigators. Combined heart failure device diagnostics identify patients at higher risk of subsequent heart failure hospitalizations: results from PARTNERS HF (Program to Access and Review Trending Information and Evaluate Correlation to Symptoms in Patients With Heart Failure) study. J Am Coll Cardiol. 2010 Apr 27;55(17):1803-10. doi: 10.1016/j.jacc.2009.11.089.

  PMID: 20413029 DERIVED

• Whellan DJ, O'Connor CM, Ousdigian KT, Lung TH; PARTNERS HF Study Investigators. Rationale, design, and baseline characteristics of a Program to Assess and Review Trending INformation and Evaluate CorRelation to Symptoms in Patients with Heart Failure (PARTNERS HF). Am Heart J. 2008 Nov;156(5):833-9, 839.e2. doi: 10.1016/j.ahj.2008.06.036. Epub 2008 Sep 23.

  PMID: 19061695 DERIVED

MeSH Terms

Conditions

Heart Failure

Interventions

Cardiac Resynchronization Therapy Devices

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Pacemaker, Artificial; Electrodes; Electrical Equipment and Supplies; Equipment and Supplies

Results Point of Contact

• Title: CRDM Core Clinical
• Organization: Medtronic CRDM Clinical Research

medtroniccrmtrials@medtronic.com

800-328-2518

Study Officials

• David Whellan, MD

  Jefferson Heart Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: January 18, 2006
• First Posted: January 20, 2006
• Study Start: June 1, 2004
• Primary Completion: March 1, 2008
• Study Completion: June 1, 2008
• Last Updated: June 15, 2012
• Results First Posted: December 8, 2011

Record last verified: 2012-06

Locations

US (93)