Heart FailurePhase 3RethinQNCT00132977
RethinQ Study - Evaluating Pacing in Heart Failure Patients
A Phase 3 study testing Cardiac Resynchronization Therapy in people with Heart Failure, run by Abbott Medical Devices at 34 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Cardiac Resynchronization Therapy
- Type of treatment
- Medical device
- How many people
- 250 participants
- Where
- 34 sitesUnited States
- Study dates
- Jul 2005to Jul 2007
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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
Who may be able to join
- 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).
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
34 sites in 1 country.
34 sites in 1 country
United States34 sites
Emory University
Atlanta, Georgia, 30306
University Hospital University of Alabama at Birmingham
Birmingham, Alabama, 35294
Massachusetts General Hospital
Boston, Massachusetts, 02114
Deborah Heart and Lung Center
Browns Mills, New Jersey, 08015
Medical University of Southern California
Charleston, South Carolina, 29401
Unversity of Chicago
Chicago, Illinois, 30322
University Hospitals of Cleveland
Cleveland, Ohio, 44106
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
The Ohio State University
Columbus, Ohio, 43210
Iowa Heart Center
Des Moines, Iowa, 50314
St. John Hospital and Medical Center
Detroit, Michigan, 48236
Elyria Regional Medical Center
Elyria, Ohio, 44035
Stern Cardiovascular Center
Germantown, Tennessee, 38138
Glendale Memorial Hospital and Medical Center
Glendale, California, 91204
St. Francis Hospital and Medical Center
Hartford, Connecticut, 06105
Shands Jacksonville
Jacksonville, Florida, 32209
Scripps Green Hospital
La Jolla, California, 92037
Ingham Regional Medical Center
Lansing, Michigan, 48910
Central Baptist Hospital
Lexington, Kentucky, 40503
Nebraska Heart Institute
Lincoln, Nebraska, 68526
Arkansas Cardiology, PA
Little Rock, Arkansas, 72205
Arkansas Heart Hospital
Little Rock, Arkansas, 72211
Loyola University Medical Center
Maywood, Illinois, 60153
St. Thomas Hospital
Nashville, Tennessee, 37205
New York Presbyterian Hospital/Cornell University
New York, New York, 10021
Mount Sinai Hospital
New York, New York, 10029
Orlando Regional Medical Center
Orlando, Florida, 32806
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
St. Francis Hospital
Roslyn, New York, 11576
Mercy General Hospital
Sacramento, California, 95819
United Hospital
Saint Paul, Minnesota, 55102
Arizona Arrhythmia Consultants
Scottsdale, Arizona, 85251
Baystate Medical Center
Springfield, Massachusetts, 01199
Main Line Health Center/Lankenau Hospital
Wynnewood, Pennsylvania, 10969
About this study
Official title: Resynchronization Therapy in Normal QRS (RethinQ) Clinical Investigation
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.
Read the detailed description
1.0 Problem of Interest
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. Current market-approved devices combine both pacing (CRT) and shocking (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 at the same time 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 (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.
2.0 Study Summary
Testing will be performed to determine if patients are eligible for this study. An EKG (electrical tracing of the heart) will be performed. They will be asked to complete a 6- minute hall walk test that will provide information regarding their ability to exercise and conduct daily activities. An echocardiogram with tissue Doppler imaging (ultrasound of the heart) will be performed to determine how the heart muscle contracts. Results of this echocardiogram will determine if patients are eligible to participate in this study.
The device system that will be implanted consists of a St. Jude Medical CRT-D and three pacing leads (insulted wires that carry electrical energy from the device to the heart). One lead is placed in the upper right chamber of the heart (atrium), a second lead is placed in the lower right chamber of the heart (right ventricle) and the third lead is placed within a vein that runs along the outside of the heart and is positioned at a location near the left lower chamber of the heart (left ventricle).
A randomization visit will occur approximately 14 days after implant. Patients will be randomized (like a flip of a coin) to one of two groups. Each patient will have an equal chance of being randomized to either of the two groups. One group will receive cardiac resynchronization treatment (CRT ON) and the other group will not receive cardiac resynchronization treatment (CRT OFF). Patients in the CRT OFF group can receive cardiac resynchronization treatment at 6 months after randomization if the doctor determines that it is appropriate.
Prior to randomization and programming of the device, the following tests will be completed:
- Quality of Life Questionnaire - contains 21 questions that provide information as to how heart failure affects the patient's daily life.
- EKG
- 6-Minute Hall.
- Cardiopulmonary Exercise Stress Testing (CPX) - measures the amount of oxygen used by your body while exercising on a treadmill and breathing through a special breathing tube
- Echocardiogram
Follow-up visits will occur at 3 and 6 months following randomization and every 6 months thereafter until the end of the study. The tests performed at the randomization visit (Quality of Life Questionnaire, EKG, 6 minute hall walk, CPX and echocardiogram) will be repeated at the 6-month follow-up visit. Additionally, each visit will include a review of the patient's condition and current medications and an evaluation of the CRT-D device.
3.0 How Will the Research Advance Scientific Knowledge and/or Human Health?
It is hoped that by pacing both lower chambers of the heart in these patients that they will feel better. They may be able to do more activities with fewer symptoms. In addition, the information gathered in this study will add to the understanding of treatment options for patients with heart failure.
4.0 What is the Current Standard of Care?
Alternative treatments to the St. Jude Medical CRT-D system (includes the left heart lead) currently available include implantation of a standard ICD system and/or treatment with medications.
- Conditions
- Heart Failure
- Being tested
- Cardiac Resynchronization Therapy
- Keywords
- Cardiac Resynchronization Therapy, Heart Failure, Mechanical Dyssynchrony
- 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 TherapyDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac resynchronization therapy (CRT) effectiveness will be evaluated in terms of exercise capacity (peak VO2), as measured by cardiopulmonary exercise testing
Measured: 6 months
Safety will be evaluated in terms of survival from CRT-D system-related complications.
Measured: 6 months
Secondary outcomes (2)
Quality of Life Questionnaire
Measured: 6 months
New York Heart Association (NYHA) Classification
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2005 (estimated)
- Study startJul 2005
- Primary completionJul 2007
- Study completionJul 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- John Beshai, MD, Study chair, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00132977
- Sponsor's protocol ID
- G050084
- Acronym
- RethinQ
- Status last verified
- Feb 2019
- First submitted
- 18 Aug 2005
- Last updated
- 4 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 17899346Beshai 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.
PubMed 17986493
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Resynchronization Therapy in Normal QRS (RethinQ) Clinical Investigation
- ClinicalTrials.gov ID
- NCT00132977
- Acronym / sponsor ID
- RethinQ / G050084
- Conditions
- Heart Failure
- Keywords
- Cardiac Resynchronization Therapy, Heart Failure, Mechanical Dyssynchrony
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- Jul 2005
- Primary completion
- Jul 2007 (actual)
- Study completion
- Jul 2007 (actual)
- First posted
- 22 Aug 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
1.0 Problem of Interest
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. Current market-approved devices combine both pacing (CRT) and shocking (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 at the same time 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 (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.
2.0 Study Summary
Testing will be performed to determine if patients are eligible for this study. An EKG (electrical tracing of the heart) will be performed. They will be asked to complete a 6- minute hall walk test that will provide information regarding their ability to exercise and conduct daily activities. An echocardiogram with tissue Doppler imaging (ultrasound of the heart) will be performed to determine how the heart muscle contracts. Results of this echocardiogram will determine if patients are eligible to participate in this study.
The device system that will be implanted consists of a St. Jude Medical CRT-D and three pacing leads (insulted wires that carry electrical energy from the device to the heart). One lead is placed in the upper right chamber of the heart (atrium), a second lead is placed in the lower right chamber of the heart (right ventricle) and the third lead is placed within a vein that runs along the outside of the heart and is positioned at a location near the left lower chamber of the heart (left ventricle).
A randomization visit will occur approximately 14 days after implant. Patients will be randomized (like a flip of a coin) to one of two groups. Each patient will have an equal chance of being randomized to either of the two groups. One group will receive cardiac resynchronization treatment (CRT ON) and the other group will not receive cardiac resynchronization treatment (CRT OFF). Patients in the CRT OFF group can receive cardiac resynchronization treatment at 6 months after randomization if the doctor determines that it is appropriate.
Prior to randomization and programming of the device, the following tests will be completed:
- Quality of Life Questionnaire - contains 21 questions that provide information as to how heart failure affects the patient's daily life.
- EKG
- 6-Minute Hall.
- Cardiopulmonary Exercise Stress Testing (CPX) - measures the amount of oxygen used by your body while exercising on a treadmill and breathing through a special breathing tube
- Echocardiogram
Follow-up visits will occur at 3 and 6 months following randomization and every 6 months thereafter until the end of the study. The tests performed at the randomization visit (Quality of Life Questionnaire, EKG, 6 minute hall walk, CPX and echocardiogram) will be repeated at the 6-month follow-up visit. Additionally, each visit will include a review of the patient's condition and current medications and an evaluation of the CRT-D device.
3.0 How Will the Research Advance Scientific Knowledge and/or Human Health?
It is hoped that by pacing both lower chambers of the heart in these patients that they will feel better. They may be able to do more activities with fewer symptoms. In addition, the information gathered in this study will add to the understanding of treatment options for patients with heart failure.
4.0 What is the Current Standard of Care?
Alternative treatments to the St. Jude Medical CRT-D system (includes the left heart lead) currently available include implantation of a standard ICD system and/or treatment with medications.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiac Resynchronization Therapy | Device | – |
Primary outcome
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
2 secondary outcomes
Quality of Life Questionnaire
Time frame: 6 months
New York Heart Association (NYHA) Classification
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2019.
- Background: PubMed 17899346Beshai 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.
- Results publication: PubMed 17986493Beshai 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Beshai, MD study chair
University of Chicago
34 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Cardiac Resynchronization Therapy in people with Heart Failure, run by Abbott Medical Devices at 34 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 9 inclusion and 14 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 4 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 34 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
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). The study lists 2 primary outcomes in all. 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 NCT00132977, 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 4 Feb 2019.