Status:
COMPLETED
Predicting Response to Cardiac Resynchronization Therapy in Heart Failure
Lead Sponsor:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Heart Failure
Left Ventricular Dysfunction
Eligibility:
All Genders
18+ years
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 functio...
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 3...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
July 28 2006
Trial Type :
OBSERVATIONAL
End Date :
May 29 2007
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT00359372
Start Date
July 28 2006
End Date
May 29 2007
Last Update
July 2 2017
Active Locations (3)
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1
Mid-Atlantic Associates
Baltimore, Maryland, United States
2
Suburban Hospital
Bethesda, Maryland, United States, 20814
3
National Heart, Lung and Blood Institute (NHLBI), 9000 Rockville Pike
Bethesda, Maryland, United States, 20892