Predicting Response to Cardiac Resynchronization Therapy in Heart Failure
Heart Failure, Left Ventricular Dysfunction
About this trial
This is an observational trial for Heart Failure focused on measuring Chronic Heart Failure, Cardiac Resynchronization, Magnetic Resonance Imaging, Biventricular Pacing, Heart Function, CRT
Eligibility Criteria
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.
Sites / Locations
- Mid-Atlantic Associates
- Suburban Hospital
- National Heart, Lung and Blood Institute (NHLBI), 9000 Rockville Pike