NCT00453622

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
222

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2005

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2005

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

March 27, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 29, 2007

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
Last Updated

February 4, 2019

Status Verified

February 1, 2019

Enrollment Period

6.8 years

First QC Date

March 27, 2007

Last Update Submit

February 1, 2019

Conditions

Heart Failure

Keywords

Heart FailureCardiac Resynchronization TherapyRisk stratificationPredictionProteomicsChemokinecardiac enzymesBrain Natriuretic Peptide

Outcome Measures

Primary Outcomes (2)

  • All Cause Death

    1 year follow up

  • First Heart Failure Hospitalization

    1 year follow up

Secondary Outcomes (1)

  • • Cause of death and ejection fraction

    1 year follow up

Interventions

Cardiac Resynchronization Therapy-DefibrillatorDEVICE

Implantation of a CRT-D device

Also known as: CRT-D device

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

heart failure patients indicated for the CRT-D therapy

You may qualify if:

  • Referred for implantation of CRT-D according to currently accepted guidelines.
  • 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

You may not qualify if:

  • 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™

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Veterans' Adminstration Pittsburgh Healthcare System

Pittsburgh, Pennsylvania, 15240, United States

Location

Related Publications (1)

  • 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.

    PMID: 25677851DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples will be collected

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Aala Shalaby, MD, FACC

    Veteran's Administration, Pittsburgh Healthcare System

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 27, 2007

First Posted

March 29, 2007

Study Start

November 1, 2005

Primary Completion

August 1, 2012

Study Completion

August 1, 2012

Last Updated

February 4, 2019

Record last verified: 2019-02

Locations

US(1)