RethinQ Study - Evaluating Pacing in Heart Failure Patients

NCT00132977 | Completed Phase 3 DMC

• 1 other identifier: G050084
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 34

Brief Summary

Patients with heart failure have a pumping action of the ventricles in which one ventricle contracts before the other ventricle. This uncoordinated (unsynchronized) pumping is due to a delay in the stimulation of the left ventricle because of its increased size. Pacing both the right and the left side of the heart (or cardiac resynchronization therapy \[CRT\]) has been proven to be effective in the treatment of heart failure (HF). Current market-approved devices combine both pacing (CRT) and shocking (implantable cardioverter defibrillator \[ICD\]) therapy for patients who have severe heart failure and are at risk for developing life-threatening heart rhythms. These devices provide an electrical pacing stimulus to both ventricles and may help the heart contract in a more coordinated way and improve heart failure symptoms. The investigational portion of this trial involves the implantation of a market-approved CRT implantable cardioverter defibrillator (CRT-D) system in patients who do not meet the current criteria for a CRT implant. In order to receive a CRT-D implant today, patients must have heart failure symptoms, have a weakened heart muscle, and have uncoordinated pumping of the heart. To demonstrate this uncoordinated pumping of the heart, a test (electrocardiogram \[ECG\]) is done. It is believed that by using a different test (echocardiogram) to measure whether this uncoordinated pumping is present, more patients will be identified that will benefit from CRT-D therapy. This study will look at whether patients identified by using this echocardiogram test show a benefit from having this CRT-D therapy.

Conditions

Heart Failure

Keywords

Cardiac Resynchronization Therapy; Heart Failure; Mechanical Dyssynchrony

Outcome Measures

Primary Outcomes (2)

• Cardiac resynchronization therapy (CRT) effectiveness will be evaluated in terms of exercise capacity (peak VO2), as measured by cardiopulmonary exercise testing

  6 months

• Safety will be evaluated in terms of survival from CRT-D system-related complications.

  6 months

Secondary Outcomes (2)

• Quality of Life Questionnaire

  6 months

• New York Heart Association (NYHA) Classification

  6 months

Interventions

Cardiac Resynchronization Therapy DEVICE

Eligibility Criteria

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

You may qualify if:

• Have an approved indication for implantation of an ICD.
• Have advanced HF with a New York Heart Association (NYHA) Classification of III, despite receiving optimal pharmacological therapy.
• Have a stable heart failure medical regimen.
• Have a left ventricular ejection fraction (LVEF) \<= 35%.
• Have evidence of mechanical dyssynchrony as measured by echocardiography using tissue Doppler imaging or M-mode.
• Have a QRS duration \< 130 ms (present in all ECG leads).
• Have the ability to complete exercise stress testing and 6-minute hall walk test, with the only limiting factors being related to cardiac fitness.
• Have the ability to independently comprehend and complete a quality of life questionnaire.
• Have the ability to provide informed consent for study participation and be willing and able to comply with the prescribed follow-up tests and schedule of evaluations.

You may not qualify if:

• Have a standard bradycardic indication for pacing.
• Have been previously treated with CRT.
• Have continuous atrial fibrillation \[AF\] (continuous is defined as AF lasting \> 1 month) within 1 year prior to enrollment or have undergone cardioversion for AF in the past month.
• Have the ability to walk \> 450 meters during the 6-minute walk test.
• Have a NYHA Classification of I, II or IV.
• Have symptomatic chronic obstructive pulmonary disease (COPD) as it relates to exercise ability.
• Have a classification of Status 1 for cardiac transplantation or consideration for transplantation over the next 6 months.
• Have had a recent myocardial infarction, unstable angina or cardiac revascularization (percutaneous transluminal coronary angioplasty \[PTCA\] or coronary artery bypass graft \[CABG\]) within 40 days of enrollment.
• Have had a recent cerebrovascular accident (CVA) or transient ischemic attack (TIA) within 3 months of enrollment.
• Have severe musculoskeletal disorder(s).
• Pregnant or planning for pregnancy in the next 6 months.
• Currently participating in, or have participated in any clinical investigation within the last 30 days (the only exception being that of a registry trial).
• Have a life expectancy of less than 6 months.
• Less than 18 years of age.

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (34)

University Hospital University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

Arizona Arrhythmia Consultants

Scottsdale, Arizona, 85251, United States

Location

Arkansas Cardiology, PA

Little Rock, Arkansas, 72205, United States

Location

Arkansas Heart Hospital

Little Rock, Arkansas, 72211, United States

Location

Glendale Memorial Hospital and Medical Center

Glendale, California, 91204, United States

Location

Scripps Green Hospital

La Jolla, California, 92037, United States

Location

Mercy General Hospital

Sacramento, California, 95819, United States

Location

St. Francis Hospital and Medical Center

Hartford, Connecticut, 06105, United States

Location

Shands Jacksonville

Jacksonville, Florida, 32209, United States

Location

Orlando Regional Medical Center

Orlando, Florida, 32806, United States

Location

Emory University

Atlanta, Georgia, 30306, United States

Location

Unversity of Chicago

Chicago, Illinois, 30322, United States

Location

Loyola University Medical Center

Maywood, Illinois, 60153, United States

Location

Iowa Heart Center

Des Moines, Iowa, 50314, United States

Location

Central Baptist Hospital

Lexington, Kentucky, 40503, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Baystate Medical Center

Springfield, Massachusetts, 01199, United States

Location

St. John Hospital and Medical Center

Detroit, Michigan, 48236, United States

Location

Ingham Regional Medical Center

Lansing, Michigan, 48910, United States

Location

United Hospital

Saint Paul, Minnesota, 55102, United States

Location

Nebraska Heart Institute

Lincoln, Nebraska, 68526, United States

Location

Deborah Heart and Lung Center

Browns Mills, New Jersey, 08015, United States

Location

New York Presbyterian Hospital/Cornell University

New York, New York, 10021, United States

Location

Mount Sinai Hospital

New York, New York, 10029, United States

Location

St. Francis Hospital

Roslyn, New York, 11576, United States

Location

University Hospitals of Cleveland

Cleveland, Ohio, 44106, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

The Ohio State University

Columbus, Ohio, 43210, United States

Location

Elyria Regional Medical Center

Elyria, Ohio, 44035, United States

Location

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Main Line Health Center/Lankenau Hospital

Wynnewood, Pennsylvania, 10969, United States

Location

Medical University of Southern California

Charleston, South Carolina, 29401, United States

Location

Stern Cardiovascular Center

Germantown, Tennessee, 38138, United States

Location

St. Thomas Hospital

Nashville, Tennessee, 37205, United States

Location

Related Publications (2)

• Beshai JF, Grimm R. The resynchronization therapy in narrow QRS study (RethinQ study): methods and protocol design. J Interv Card Electrophysiol. 2007 Sep;19(3):149-55. doi: 10.1007/s10840-007-9156-3.

  PMID: 17899346 BACKGROUND

• Beshai JF, Grimm RA, Nagueh SF, Baker JH 2nd, Beau SL, Greenberg SM, Pires LA, Tchou PJ; RethinQ Study Investigators. Cardiac-resynchronization therapy in heart failure with narrow QRS complexes. N Engl J Med. 2007 Dec 13;357(24):2461-71. doi: 10.1056/NEJMoa0706695. Epub 2007 Nov 6.

  PMID: 17986493 RESULT

MeSH Terms

Conditions

Heart Failure

Interventions

Cardiac Resynchronization Therapy

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Cardiac Pacing, Artificial; Electric Stimulation Therapy; Therapeutics

Study Officials

• John Beshai, MD

  University of Chicago

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2005
• First Posted: August 22, 2005
• Study Start: July 1, 2005
• Primary Completion: July 1, 2007
• Study Completion: July 1, 2007
• Last Updated: February 4, 2019

Record last verified: 2019-02

Locations

US (34)