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Heart Failure, CongestiveNCT00279955

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

An observational study of Heart Failure, Congestive, run by Medtronic Cardiac Rhythm and Heart Failure at 93 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Heart Failure, Congestive
What is being tested?
Cardiac Resynchronization Therapy Device
Type of treatment
Medical device
How many people
1,024 participants
Where
93 sitesUnited States
Study dates
Jun 2004to Jun 2008
Phase
Observational
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

93 sites in 1 country.

93 sites in 1 country

United States93 sites

  • Study site

    Atlanta, Georgia

  • Study site

    Augusta, Georgia

  • Study site

    Bismarck, North Dakota

  • Study site

    Bradenton, Florida

  • Study site

    Burlington, Vermont

  • Study site

    Camp Hill, Pennsylvania

  • Study site

    Charlotte, North Carolina

  • Study site

    Cherryhill, New Jersey

  • Study site

    Cincinnati, Ohio

  • Study site

    Columbia, South Carolina

  • Study site

    Columbus, Ohio

  • Study site

    Covington, Louisiana

  • Study site

    Dayton, Ohio

  • Study site

    Denver, Colorado

  • Study site

    Durham, North Carolina

  • Study site

    Edgewood, Kentucky

  • Study site

    Elyria, Ohio

  • Study site

    Erie, Pennsylvania

  • Study site

    Evanston, Illinois

  • Study site

    Fairfax, Texas

  • Study site

    Fargo, North Dakota

  • Study site

    Florence, Kentucky

  • Study site

    Fort Lauderdale, Florida

  • Study site

    Fort Worth, Texas

  • Study site

    Grand Rapids, Michigan

  • Study site

    Green Bay, Wisconsin

  • Study site

    Greensboro, North Carolina

  • Study site

    Guilford, Connecticut

  • Study site

    Honolulu, Hawaii

  • Study site

    Huntsville, Alabama

  • Study site

    Key Largo, Florida

  • Study site

    Kirkland, Washington

  • Study site

    Knoxville, Tennessee

  • Study site

    Lakewood, Ohio

  • Study site

    Las Vegas, Nevada

  • Study site

    Little Rock, Arkansas

  • Study site

    Loma Linda, California

  • Study site

    Louisville, Kentucky

  • Study site

    Lubbock, Texas

  • Study site

    Lynchburg, Virginia

  • Study site

    Madison, Wisconsin

  • Study site

    Manchester, New Hampshire

  • Study site

    Marquette, Michigan

  • Study site

    Mayfield Heights, Ohio

  • Study site

    Maywood, Illinois

  • Study site

    Medford, Oregon

  • Study site

    Melbourne, Florida

  • Study site

    Merrionette Park, Illinois

  • Study site

    Miami, Florida

  • Study site

    Minneapolis, Minnesota

  • Study site

    Missoula, Montana

  • Study site

    Monroe, Louisiana

  • Study site

    Nashville, Tennessee

  • Study site

    New York, New York

  • Study site

    Norfolk, Virginia

  • Study site

    Orlando, Florida

  • Study site

    Palm Beach Gardens, Florida

  • Study site

    Pawtucket, Rhode Island

  • Study site

    Pensacola, Florida

  • Study site

    Petoskey, Michigan

  • Study site

    Philadelphia, Pennsylvania

  • Study site

    Phoenix, Arizona

  • Study site

    Pittsburgh, Pennsylvania

  • Study site

    Portland, Maine

  • Study site

    Providence, Rhode Island

  • Study site

    Raleigh, North Carolina

  • Study site

    Richmond, Virginia

  • Study site

    Ridgewood, New Jersey

  • Study site

    Rockford, Illinois

  • Study site

    Safety Harbor, Florida

  • Study site

    Saint Cloud, Minnesota

  • Study site

    Salisbury, Maryland

  • Study site

    San Diego, California

  • Study site

    Scottsdale, Arizona

  • Study site

    Sewell, New Jersey

  • Study site

    Sioux Falls, South Dakota

  • Study site

    Spartanburg, South Carolina

  • Study site

    Springfield, Illinois

  • Study site

    St Louis, Missouri

  • Study site

    Takoma Park, Maryland

  • Study site

    Tallahassee, Florida

  • Study site

    Tampa, Florida

  • Study site

    The Bronx, New York

  • Study site

    Topeka, Kansas

  • Study site

    Traverse City, Michigan

  • Study site

    West Islip, New York

  • Study site

    Westlake, Ohio

  • Study site

    Wichita, Kansas

  • Study site

    Williamsville, New York

  • Study site

    Winfield, Illinois

  • Study site

    Winter Park, Florida

  • Study site

    Wormleysburg, Pennsylvania

  • Study site

    York, Pennsylvania

Other trials in United States

About this study

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

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.

Being tested
Cardiac Resynchronization Therapy Device
Keywords
Heart Failure, Congestive, Implantable Cardioverter-Defibrillators
Medical subject headings
Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cardiac Resynchronization Therapy DeviceDevice

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

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: From 6 month to the 12 month visit

Secondary outcomes (2)

  1. Occurrence of Heart Failure (HF) Related Healthcare Utilization (HU)

    Number of participates with HF realted healthcare utilization will be reported. Time to the first HF-related healthcare utilization 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 healthcare utilization between two groups. A heart failure related (HF-related) healthcare utilization is defined as unscheduled office visits, hospitalizations, urgent care visits, and emergency room visits which is resulted by heart failure related adverse event.

    Measured: 6 month to the 12 month visit

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

    Number of participates with HF related pulmonary congestion event will be reported. Time to the first HF related pulmonary cogestion event in the "Follow-up Period" from the 6-month visit to the 12-month visit is compared between two risk groups to see if there is significant difference. A HF related pulmonary congestion event is defined as hospitalization with signs and/or symptoms of pulmonary congestion, or outpatient treatment with IV diuretics due to exacerbation of HF with signs and/or symptoms of pulmonary congestion.

    Measured: 6 month to the 12 month visit

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jan 2006 (estimated)
  2. Study startJun 2004
  3. Primary completionMar 2008
  4. Study completionJun 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,024 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00279955
Sponsor's protocol ID
235
Status last verified
Jun 2012
First submitted
18 Jan 2006
Last updated
15 Jun 2012

Publications

  • 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.

    PubMed 20413029

  • 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.

    PubMed 19061695

Questions about this trial

What is this clinical trial studying?

An observational study of Heart Failure, Congestive, run by Medtronic Cardiac Rhythm and Heart Failure at 93 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 93 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Dec 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Occurrence of Heart Failure (HF) Related Adverse Event (AE) (time frame: From 6 month to the 12 month visit). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00279955, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2012.

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