Clinical trial NCT00279955: PARTNERS HF: Program to Access and Review Trending Information and Evaluate Correlation to Symptoms in Patients With Heart Failure
Official title: Program to Access and Review Trending Information and Evaluate Correlation to Symptoms in Patients With Heart Failure
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure, Congestive
Keywords: Heart Failure, Congestive
Implantable Cardioverter-Defibrillators
Lead sponsor: Medtronic Cardiac Rhythm and Heart Failure
Sponsor class: INDUSTRY
Collaborators: name: Medtronic
First posted: 2006-01-20
Enrollment: 1024
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Occurrence of Heart Failure (HF) Related Adverse Event (AE)
timeFrame: From 6 month to the 12 month visit
Secondary outcomes:
measure: Occurrence of Heart Failure (HF) Related Healthcare Utilization (HU)
timeFrame: 6 month to the 12 month visit
measure: Occurrence of Heart Failure (HF) Related Pulmonary Congestion Event (PCE)
timeFrame: 6 month to the 12 month visit
Other outcomes:
Locations:
city: Huntsville
country: United States
state: Alabama
city: Phoenix
country: United States
state: Arizona
city: Scottsdale
country: United States
state: Arizona
city: Little Rock
country: United States
state: Arkansas
city: Loma Linda
country: United States
state: California
city: San Diego
country: United States
state: California
city: Denver
country: United States
state: Colorado
city: Guilford
country: United States
state: Connecticut
city: Bradenton
country: United States
state: Florida
city: Ft. Lauderdale
country: United States
state: Florida
city: Key Largo
country: United States
state: Florida
city: Melbourne
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Orlando
country: United States
state: Florida
city: Palm Beach Gardens
country: United States
state: Florida
city: Pensacola
country: United States
state: Florida
city: Safety Harbor
country: United States
state: Florida
city: Tallahassee
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: Winter Park
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Augusta
country: United States
state: Georgia
city: Honolulu
country: United States
state: Hawaii
city: Evanston
country: United States
state: Illinois
city: Maywood
country: United States
state: Illinois
city: Merrionette Park
country: United States
state: Illinois
city: Rockford
country: United States
state: Illinois
city: Springfield
country: United States
state: Illinois
city: Winfield
country: United States
state: Illinois
city: Topeka
country: United States
state: Kansas
city: Wichita
country: United States
state: Kansas
city: Edgewood
country: United States
state: Kentucky
city: Florence
country: United States
state: Kentucky
city: Louisville
country: United States
state: Kentucky
city: Covington
country: United States
state: Louisiana
city: Monroe
country: United States
state: Louisiana
city: Portland
country: United States
state: Maine
city: Salisbury
country: United States
state: Maryland
city: Takoma Park
country: United States
state: Maryland
city: Grand Rapids
country: United States
state: Michigan
city: Marquette
country: United States
state: Michigan
city: Petoskey
country: United States
state: Michigan
city: Traverse City
country: United States
state: Michigan
city: Minneapolis
country: United States
state: Minnesota
city: St. Cloud
country: United States
state: Minnesota
city: St. Louis
country: United States
state: Missouri
city: Missoula
country: United States
state: Montana
city: Las Vegas
country: United States
state: Nevada
city: Manchester
country: United States
state: New Hampshire
city: Cherryhill
country: United States
state: New Jersey
city: Ridgewood
country: United States
state: New Jersey
city: Sewell
country: United States
state: New Jersey
city: Bronx
country: United States
state: New York
city: New York
country: United States
state: New York
city: West Islip
country: United States
state: New York
city: Williamsville
country: United States
state: New York
city: Charlotte
country: United States
state: North Carolina
city: Durham
country: United States
state: North Carolina
city: Greensboro
country: United States
state: North Carolina
city: Raleigh
country: United States
state: North Carolina
city: Bismarck
country: United States
state: North Dakota
city: Fargo
country: United States
state: North Dakota
city: Cincinnati
country: United States
state: Ohio
city: Columbus
country: United States
state: Ohio
city: Dayton
country: United States
state: Ohio
city: Elyria
country: United States
state: Ohio
city: Lakewood
country: United States
state: Ohio
city: Mayfield Heights
country: United States
state: Ohio
city: West Lake
country: United States
state: Ohio
city: Medford
country: United States
state: Oregon
city: Camp Hill
country: United States
state: Pennsylvania
city: Erie
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Pittsburgh
country: United States
state: Pennsylvania
city: Wormleysburg
country: United States
state: Pennsylvania
city: York
country: United States
state: Pennsylvania
city: Pawtucket
country: United States
state: Rhode Island
city: Providence
country: United States
state: Rhode Island
city: Columbia
country: United States
state: South Carolina
city: Spartanburg
country: United States
state: South Carolina
city: Sioux Falls
country: United States
state: South Dakota
city: Knoxville
country: United States
state: Tennessee
city: Nashville
country: United States
state: Tennessee
city: Fairfax
country: United States
state: Texas
city: Fort Worth
country: United States
state: Texas
city: Lubbock
country: United States
state: Texas
city: Burlington
country: United States
state: Vermont
city: Lynchburg
country: United States
state: Virginia
city: Norfolk
country: United States
state: Virginia
city: Richmond
country: United States
state: Virginia
city: Kirkland
country: United States
state: Washington
city: Green Bay
country: United States
state: Wisconsin
city: Madison
country: United States
state: Wisconsin
Study officials:
affiliation: Jefferson Heart Institute
name: David Whellan, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.