RISK Stratification Using a Combination of Cardiac Troponin T and Brain Natriuretic Peptide in Patients Receiving CRT-D
| Status: | Completed |
|---|---|
| Conditions: | Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - 90 |
| Updated: | 2/6/2019 |
| Start Date: | November 2005 |
| End Date: | August 2012 |
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 (HF)improvement 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.
and brain natriuretic peptide (BNP) can predict Heart Failure (HF)improvement 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.
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 treatment(s) 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
2.3 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 AT/AF, VT/VF episodes
- Frequency of appropriate/inappropriate ICD therapy
- % Atrial and Ventricular Pacing
- Antiarrhythmic drug utilization
- Study related complications
2.3.1 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 treatment(s) 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
2.3 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 AT/AF, VT/VF episodes
- Frequency of appropriate/inappropriate ICD therapy
- % Atrial and Ventricular Pacing
- Antiarrhythmic drug utilization
- Study related complications
2.3.1 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%
Inclusion Criteria:
- Referred for implantation of CRT-D according to currently accepted guidelines.
- 18 years or older
- Ability to independently comprehend and complete a QOL questionnaire
- Ability to provide informed consent for a study and be willing and able to comply with
the prescribed follow-up
- Has stable conventional medications at least one month prior to enrollment
Exclusion Criteria:
- Inability to successfully implant an intravascular lead CRT-D device. (i.e. exclude
epicardial leads)
- Myocardial infarction or unstable angina in the last 3 weeks
- Chronic atrial fibrillation (continuous AF lasting > 1 Month) within 1 year prior to
enrollment or having undergone cardioversion for AF in the past month
- Status 1 classification for cardiac transplantation
- Currently participating in a clinical trial that includes an active treatment arm
- Life expectancy of less than 6 months.
- Recent (within 24 hours) administration of Nesiritide™
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