- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00359372
Predicting Response to Cardiac Resynchronization Therapy in Heart Failure
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.
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment
Contacts and Locations
Study Locations
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Maryland
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Baltimore, Maryland, United States
- Mid-Atlantic Associates
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Bethesda, Maryland, United States, 20814
- Suburban Hospital
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Bethesda, Maryland, United States, 20892
- National Heart, Lung and Blood Institute (NHLBI), 9000 Rockville Pike
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
- INCLUSION and EXCLUSION CRITERIA
No one will be excluded from this study based on race, gender, and ethnicity.
INCLUSION CRITERIA
- LV dysfunction with an LV ejection fraction less than or equal to 35% (by clinical echocardiography, cardiac catheterization, radionuclide ventriculography, or MRI).
- New York Heart Association (NYHA) class III or IV functional status
- QRS interval greater than or equal to 120msec (measured on clinical ECG)
- 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
- Coronary artery bypass graft surgery or percutaneous coronary intervention within 60 days of enrollment.
- Chronic medically refractory atrial tachyarrhythmias
- History of medical non-compliance
- 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).
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
Contraindications to MRI contrast agent administration:
i. lactating women
ii. patients with hemoglobinopathies
iii. severe renal disease (CrCl less than 20 ml/min)
- 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)
- Enrollment in any concurrent study that may confound the results of this study
- Life expectancy less than 6 months because of other medical conditions.
- Age less than 18 years since this disease is not prevalent in children.
Study Plan
How is the study designed?
Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 060216
- 06-H-0216
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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