NCT00359372

Predicting Response to Cardiac Resynchronization Therapy in Heart Failure

Completed Last updated 2 July 2017

What this trial tests

trial in Heart Failure in 180 participants. Completed in 29 May 2007.

Timeline

28 July 2006

29 May 2007

Quick facts

Lead sponsor	National Heart, Lung, and Blood Institute (NHLBI)
Status	Completed
Study type	OBSERVATIONAL
Enrollment	180
Start date	28 July 2006
Estimated completion	29 May 2007
Sites	3 locations across United States

Conditions studied

• Heart Failure — all drugs for Heart Failure →
• Left Ventricular Dysfunction — all drugs for Left Ventricular Dysfunction →

Sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Who can join

18 and older, any sex, with Heart Failure or Left Ventricular Dysfunction. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.