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

This study is currently recruiting participants.

Verified by St. Jude Medical, September 2007

First Received: March 27, 2007 Last Updated: September 10, 2007 History of Changes

Sponsors and Collaborators:	St. Jude Medical VA Pittsburgh Healthcare System
Information provided by:	St. Jude Medical
ClinicalTrials.gov Identifier:	NCT00453622

Purpose

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.

Condition	Intervention	Phase
Heart Failure	Device: Cardiac Resynchronization Therapy-Defibrillator	Phase IV

Study Type:	Interventional
Study Design:	Screening, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment
Official Title:	RISK Stratification Using a Combination of Cardiac Troponin T and Brain Natriuretic Peptide in Patients Receiving CRT-D

Resource links provided by NLM:

MedlinePlus related topics: Heart Failure

Drug Information available for: Nesiritide

U.S. FDA Resources

Further study details as provided by St. Jude Medical:

Primary Outcome Measures:

Death
First Heart Failure Hospitalization

Estimated Enrollment:

300

Eligibility

Ages Eligible for Study:	18 Years to 90 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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™

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00453622

Contacts

Contact: Bill Gross, BS, MBA	(800) 423-5611 ext 3883	wgross@sjm.com
Contact: Jeff Shafiroff, PhD	(800) 423-5611 ext 2534	jshafiroff@sjm.com

Locations

United States, Pennsylvania
Veterans' Adminstration Pittsburgh Healthcare System	Recruiting
Pittsburgh, Pennsylvania, United States, 15240
Contact: Aala Shalaby, MD FACC 412-688-6176 Alaa.Shalaby@va.gov

Sponsors and Collaborators

St. Jude Medical

VA Pittsburgh Healthcare System

Investigators

Principal Investigator:

Aala Shalaby, MD, FACC

Veteran's Administration, Pittsburgh Healthcare System

More Information

No publications provided

Study ID Numbers:	CRD303
Study First Received:	March 27, 2007
Last Updated:	September 10, 2007
ClinicalTrials.gov Identifier:	NCT00453622 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by St. Jude Medical:

Heart Failure
Cardiac Resynchronization Therapy
Risk stratification
Prediction

Proteomics
Chemokine
cardiac enzymes
Brain Natriuretic Peptide

Study placed in the following topic categories:

Natriuretic Peptide, Brain
Heart Failure
Heart Diseases
Cardiovascular Agents

Additional relevant MeSH terms:

Natriuretic Peptide, Brain
Heart Failure
Heart Diseases
Natriuretic Agents
Therapeutic Uses

Physiological Effects of Drugs
Cardiovascular Diseases
Cardiovascular Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 10, 2009