RethinQ Study - Evaluating Pacing in Heart Failure Patients - Full Text View

Sponsor:	St. Jude Medical
Information provided by:	St. Jude Medical
ClinicalTrials.gov Identifier:	NCT00132977

Purpose

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.

Condition	Intervention	Phase
Heart Failure	Device: Cardiac Resynchronization Therapy	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	Resynchronization Therapy in Normal QRS (RethinQ) Clinical Investigation

Resource links provided by NLM:

MedlinePlus related topics: Heart Failure

U.S. FDA Resources

Further study details as provided by St. Jude Medical:

Primary Outcome Measures:

Cardiac resynchronization therapy (CRT) effectiveness will be evaluated in terms of exercise capacity (peak VO2), as measured by cardiopulmonary exercise testing [ Time Frame: 6 months ]
Safety will be evaluated in terms of survival from CRT-D system-related complications. [ Time Frame: 6 months ]

Secondary Outcome Measures:

Quality of Life Questionnaire [ Time Frame: 6 months ]
New York Heart Association (NYHA) Classification [ Time Frame: 6 months ]

Enrollment:	250
Study Start Date:	July 2005
Study Completion Date:	July 2007
Primary Completion Date:	July 2007 (Final data collection date for primary outcome measure)

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Eligibility

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

Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00132977

Show 34 Study Locations

Sponsors and Collaborators

St. Jude Medical

Investigators

Study Chair:

John Beshai, MD

University of Chicago

More Information

Publications:

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. Epub 2007 Nov 6.

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.

Responsible Party:	Director, Clinical Affairs, St. Jude Medical, CRMD
ClinicalTrials.gov Identifier:	NCT00132977 History of Changes
Other Study ID Numbers:	G050084
Study First Received:	August 18, 2005
Last Updated:	May 5, 2008
Health Authority:	United States: Food and Drug Administration

Keywords provided by St. Jude Medical:

Cardiac Resynchronization Therapy
Heart Failure
Mechanical Dyssynchrony

Additional relevant MeSH terms:

Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on February 02, 2012