Ignite Creation Date:
2024-05-05 @ 4:56 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00359372
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
2006-08-01
Brief Title:
Predicting Response to Cardiac Resynchronization Therapy in Heart Failure
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Predicting Response to Cardiac Resynchronization Therapy in Heart Failure
Status:
COMPLETED
Status Verified Date:
2007-05-29
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 fibrosisscarring 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 06-H-0216 | None | None | None |