RISK Stratification Using a Combination of Cardiac Troponin T and Brain Natriuretic Peptide in Patients Receiving CRT-D

NCT ID: NCT00453622

Last Updated: 2019-02-04

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 222 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2005-11-30
• Study Completion Date: 2012-08-31

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 (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.

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 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%

Conditions

Heart Failure

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Cardiac Resynchronization Therapy-Defibrillator

Implantation of a CRT-D device

Intervention Type: DEVICE

Other Intervention Names

CRT-D device

Eligibility Criteria

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™

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

VA Pittsburgh Healthcare System

FED

Sponsor Role: collaborator

Abbott Medical Devices

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Aala Shalaby, MD, FACC

Role: PRINCIPAL_INVESTIGATOR

Veteran's Administration, Pittsburgh Healthcare System

Locations

Veterans' Adminstration Pittsburgh Healthcare System

Pittsburgh, Pennsylvania, United States

Countries

United States

References

Shalaby AA, Abraham WT, Fonarow GC, Bersohn MM, Gorcsan J 3rd, Lee LY, Halilovic J, Saba S, Maisel A, Singh JP, Sonel A, Kadish A. Association of BNP and Troponin Levels with Outcome among Cardiac Resynchronization Therapy Recipients. Pacing Clin Electrophysiol. 2015 May;38(5):581-90. doi: 10.1111/pace.12610. Epub 2015 Mar 30.

Reference Type: DERIVED

PMID: 25677851 (View on PubMed)

Other Identifiers

CRD303

Identifier Type: -

Identifier Source: org_study_id