Ignite Creation Date:
2024-05-05 @ 5:26 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00453622
Status:
COMPLETED
Last Update Posted:
2019-02-04
First Post:
2007-03-27
Brief Title:
RISK Stratification Using a Combination of Cardiac Troponin T and Brain Natriuretic Peptide in Patients Receiving CRT-D
Sponsor:
Abbott Medical Devices
Organization:
Abbott Medical Devices
Study Overview
Official Title:
RISK Stratification Using a Combination of Cardiac Troponin T and Brain Natriuretic Peptide in Patients Receiving CRT-D
Status:
COMPLETED
Status Verified Date:
2019-02
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:
RISK
Brief Summary:
The purpose of the study is to identify if the combined use of cardiac troponin enzyme cTnT and brain natriuretic peptide BNP can predict Heart Failure HFimprovement and all-cause mortality in patients implanted with cardiac pacemaker-defibrillation devices CRT-D Novel biochemical markers identifying patients with high risk cardiac mortality detected by plasma protein analysis will also be evaluated
Hypothesis 1 The combined use of cTnT and BNP at just before implant will predict and risk stratify all cause mortality or HF hospitalization up to 12 months
Hypothesis 2 The change in levels of said biomarkers at different points of follow-up can predict response to CRT through 12 months
Hypothesis 3 The levels of a panel of novel inflammatory mediators namely chemokines will be correlated with improvement in 6-minute walk testing quality of life and left ventricular ejection fraction in CRT patients
Hypothesis 1 The combined use of cTnT and BNP at just before implant will predict and risk stratify all cause mortality or HF hospitalization up to 12 months
Hypothesis 2 The change in levels of said biomarkers at different points of follow-up can predict response to CRT through 12 months
Hypothesis 3 The levels of a panel of novel inflammatory mediators namely chemokines will be correlated with improvement in 6-minute walk testing quality of life and left ventricular ejection fraction in CRT patients
Detailed Description:
Primary Endpoint
The primary endpoint is the occurrence of either death or first HF hospitalization HF hospitalizations must satisfy both of the following criteria
1 Admission to hospital for 24 hours with at least one of the following HF worsening symptoms
Increased CHF class
Orthopnea
Paroxysmal nocturnal dyspnea
Edema
Dyspnea on exertion or
Gastrointestinal GI symptoms attributable to HF
Placement on the Status I heart transplant list
AND
2 One or more of the following intensive treatments for HF within 24 hours of admission
Intravenous IV diuresis
IV inotropic medications prescribed during the hospitalization or
Increasing frequency of dialysis for patients with chronic renal failure
23 Secondary Endpoints
Secondary endpoints include
Cause of death
Change in NYHA functional class
Number of HF related hospitalizations
Performance on a standard 6-minute hall walk test
Quality of Life as measured by the Minnesota Living with Heart Failure MLWHFQ questionnaire
Patient global clinical assessment
Left ventricular ejection fraction LVEF measured by echocardiography
LV volume measured by echocardiography
LV lead placement position
QRS duration at baseline and with CRT
Number of ATAF VTVF episodes
Frequency of appropriateinappropriate ICD therapy
Atrial and Ventricular Pacing
Antiarrhythmic drug utilization
Study related complications
231 Response to CRT
1 A positive response to CRT is defined by the following Improvement in NYHA functional class by at least one grade
2 Improvement in echocardiographic LVEF left ventricular end diastolic index LVEDI
3 Improvement in patient global clinical assessment
4 Improvement in 6-minute hall walk by 10
The primary endpoint is the occurrence of either death or first HF hospitalization HF hospitalizations must satisfy both of the following criteria
1 Admission to hospital for 24 hours with at least one of the following HF worsening symptoms
Increased CHF class
Orthopnea
Paroxysmal nocturnal dyspnea
Edema
Dyspnea on exertion or
Gastrointestinal GI symptoms attributable to HF
Placement on the Status I heart transplant list
AND
2 One or more of the following intensive treatments for HF within 24 hours of admission
Intravenous IV diuresis
IV inotropic medications prescribed during the hospitalization or
Increasing frequency of dialysis for patients with chronic renal failure
23 Secondary Endpoints
Secondary endpoints include
Cause of death
Change in NYHA functional class
Number of HF related hospitalizations
Performance on a standard 6-minute hall walk test
Quality of Life as measured by the Minnesota Living with Heart Failure MLWHFQ questionnaire
Patient global clinical assessment
Left ventricular ejection fraction LVEF measured by echocardiography
LV volume measured by echocardiography
LV lead placement position
QRS duration at baseline and with CRT
Number of ATAF VTVF episodes
Frequency of appropriateinappropriate ICD therapy
Atrial and Ventricular Pacing
Antiarrhythmic drug utilization
Study related complications
231 Response to CRT
1 A positive response to CRT is defined by the following Improvement in NYHA functional class by at least one grade
2 Improvement in echocardiographic LVEF left ventricular end diastolic index LVEDI
3 Improvement in patient global clinical assessment
4 Improvement in 6-minute hall walk by 10
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