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Predicting Response to Cardiac Resynchronization Therapy in Heart Failure

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ClinicalTrials.gov Identifier: NCT00359372
Recruitment Status : Completed
First Posted : August 2, 2006
Last Update Posted : July 2, 2017
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)

Tracking Information
First Submitted Date August 1, 2006
First Posted Date August 2, 2006
Last Update Posted Date July 2, 2017
Study Start Date July 28, 2006
Primary Completion Date Not Provided
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Predicting Response to Cardiac Resynchronization Therapy in Heart Failure
Official Title Predicting Response to Cardiac Resynchronization Therapy in Heart Failure
Brief Summary

This study will explore which characteristics of patients with heart failure will likely predict improvement after cardiac resynchronization (CRT), implantation of a pacemaker to improve heart function. In spite of major medical advances, about 30% to 40% of patients with heart failure do not respond to CRT, and the reasons are not well understood. This study will involve magnetic resonance imaging (MRI), electrocardiogram (ECG), and echocardiography techniques to let researchers examine what may influence response to CRT.

Patients ages 18 and older with a left ventricular disorder and who are not pregnant or breastfeeding may be eligible for this study. Initial evaluation will take 5 to 6 hours. A blood sample of about 2 tablespoons will be collected, and several procedures will be performed. MRI uses a strong magnetic field and radio waves to obtain images of body organs and tissues. For that procedure, patients will lie on a table that slides into the enclosed tunnel of the scanner and be asked to lie still. They will be in the scanner for 30 to 90 minutes. As the scanner takes pictures, patients will hear knocking sounds, and they may be asked to hold their breath intermittently for 5 to 20 seconds. During part of the scan, a drug called gadolinium will be given intravenously (IV), to make the heart easier to see. Patients will be able to communicate with the MRI staff at all times during the scan. At any time, patients may ask to be moved out of the machine. Patients having metal in their body that interferes with the MRI scanner should not have this test. During the procedure, an ECG machine will monitor the heart, through wires connected to pads on the skin. Patients will have an echocardiogram, in which sound waves look at the heart. A small handheld probe will touch the chest and abdomen, and an IV tube may be inserted to inject a contrast drug to improve the quality of heart images. Patients will have a cardiopulmonary stress test (treadmill test) and a 6-minute walk test, both before pacemaker implantation and then 6 months afterward. Also before and after pacemaker implantation, patients will complete the Minnesota Living with Heart Failure Questionnaire, regarding the impact of heart failure on patients' lives. The follow-up visit will take 3 to 4 hours.

Detailed Description Many patients with heart failure benefit from cardiac resynchronization therapy (CRT) which involves implantation of a pacemaker to improve the coordination of heart function. However, approximately 30-40% of patients fail to respond to this therapy with current selection criteria. We hypothesize that patients with echocardiographic and MRI measures of a high degree of LV mechanical dyssynchrony are more likely to benefit from CRT than patients with less baseline dyssynchrony. Severe LV remodeling as measured by MRI may also predict patients less likely to benefit from therapy. In addition, myocardial fibrosis/scarring as measured by MRI delayed enhancement imaging may predict segments or subjects less likely to respond to CRT even in patients without ischemic heart disease. In this study, patients with New York Heart Association class III - IV heart failure will undergo imaging and stress testing prior to CRT pacemaker implantation and 6 months later to determine predictors of response. Considering the complexity of the protocol and novelty of some aspects of the MRI examination, we consider this an exploratory observational protocol.
Study Type Observational
Study Design Not Provided
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Not Provided
Study Population Not Provided
Condition
  • Heart Failure
  • Left Ventricular Dysfunction
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Abraham WT, Fisher WG, Smith AL, Delurgio DB, Leon AR, Loh E, Kocovic DZ, Packer M, Clavell AL, Hayes DL, Ellestad M, Trupp RJ, Underwood J, Pickering F, Truex C, McAtee P, Messenger J; MIRACLE Study Group. Multicenter InSync Randomized Clinical Evaluation. Cardiac resynchronization in chronic heart failure. N Engl J Med. 2002 Jun 13;346(24):1845-53.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Enrollment
 (submitted: August¬†1,¬†2006)
180
Original Enrollment Same as current
Study Completion Date May 29, 2007
Primary Completion Date Not Provided
Eligibility Criteria
  • INCLUSION and EXCLUSION CRITERIA

No one will be excluded from this study based on race, gender, and ethnicity.

INCLUSION CRITERIA

  1. LV dysfunction with an LV ejection fraction less than or equal to 35% (by clinical echocardiography, cardiac catheterization, radionuclide ventriculography, or MRI).
  2. New York Heart Association (NYHA) class III or IV functional status
  3. QRS interval greater than or equal to 120msec (measured on clinical ECG)
  4. Optimal pharmacological therapy for heart failure with at least 1 month on an ACE-inhibitor or angiotensin II receptor blocker (ARB) and if on a beta blocker, 3 months on a stable dose of a beta blocker. Patients need to be taking their medicines consistently to be enrolled in this study.

EXCLUSION CRITERIA

  1. Coronary artery bypass graft surgery or percutaneous coronary intervention within 60 days of enrollment.
  2. Chronic medically refractory atrial tachyarrhythmias
  3. History of medical non-compliance
  4. Women who are pregnant or not using medically acceptable birth control (since the x-rays used to guide pacemaker therapy may increase the risk to the fetus and the fetal risks of gadolinium are not well known).
  5. Contraindication to MRI scanning including patients with the following devices:

    i. Central nervous system aneurysm clips

    ii. Implanted neural stimulator

    iii. Implanted cardiac pacemaker or defibrillator prior to enrollment

    iv. Cochlear implant

    v. Ocular foreign body (e.g. metal shavings)

    vi. Insulin pump

    vii. Metal shrapnel or bullet

  6. Contraindications to MRI contrast agent administration:

    i. lactating women

    ii. patients with hemoglobinopathies

    iii. severe renal disease (CrCl less than 20 ml/min)

  7. Baseline 6-minute hall walk distance more than 450 meters (to exclude patients who are unlikely to truly have NYHA class III to IV heart failure)
  8. Enrollment in any concurrent study that may confound the results of this study
  9. Life expectancy less than 6 months because of other medical conditions.
  10. Age less than 18 years since this disease is not prevalent in children.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00359372
Other Study ID Numbers 060216
06-H-0216
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Not Provided
Study Sponsor National Heart, Lung, and Blood Institute (NHLBI)
Collaborators Not Provided
Investigators Not Provided
PRS Account National Institutes of Health Clinical Center (CC)
Verification Date May 29, 2007