NCT01519908

Brief Summary

The purpose of this study is to investigate: the relation of a set of (bio)markers and response to Cardiac Resynchronization Therapy (CRT); the interrelationship as well as the potential predictive power of these (bio)markers on improvement and/or deterioration of cardiac function, cardiac geometry (reverse re-modeling during CRT) will be evaluated. (Bio)markers include but are not limited to: collagen, genomic markers, molecular markers, electrocardiographic markers, echocardiographic markers, arrhythmogenic markers and markers for renal function: blood urea nitrogen (BUN), serum creatinine, glomerular filtration rate (GFR).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
240

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2012

Typical duration for all trials

Geographic Reach
1 country

6 active sites

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

First Submitted

Initial submission to the registry

January 24, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 27, 2012

Completed
5 days until next milestone

Study Start

First participant enrolled

February 1, 2012

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

April 18, 2024

Status Verified

April 1, 2024

Enrollment Period

2.8 years

First QC Date

January 24, 2012

Last Update Submit

April 16, 2024

Conditions

Heart Failure

Keywords

cardiac resynchronization therapybiomarkersresponse

Outcome Measures

Primary Outcomes (1)

  • Correlation of biomarkers with reverse remodeling in cardiac resynchronization therapy

    To investigate the relationship between a set of (bio)markers and response to cardiac resynchronization therapy (as measured by echocardiography) at 6 months. For each biomarker, the relation with LVESVi change between baseline and 6 months post implant will be analyzed.

    6 months

Secondary Outcomes (5)

  • Correlation of biomarker with reverse remodeling in cardiac resynchronization therapy

    12 months

  • Correlation of biomarkers and atrial fibrillation in cardiac resynchronization therapy

    12 months

  • Correlation of biomarkers and ventricular arrhythmias in cardiac resynchronization therapy

    12 months

  • Correlation of biomarkers with echocardiographic changes in cardiac resynchronization therapy

    12 months

  • Correlation of anatomy and function with response to cardiac resynchronization therapy

    12 months

Interventions

CRT-D (Medtronic)DEVICE

Biventricular implantable cardioverter defibrillator, post marketing release

Also known as: Medtronic CRT-D device

Eligibility Criteria

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

The study group to be recruited will consist of symptomatic heart failure patients (NYHA II-III), male and female, with a reduced left ventricular ejection fraction and ventricular dyssynchrony as measured prior to implantation of a cardiac resynchronization therapy device (CRT-D). Each study subject receives a CRT-Daccording to the current ESC/AHA guidelines.

You may qualify if:

  • Subject is indicated for CRT-D device according to current applicable ESC/AHA guidelines
  • Subject has NYHA class II or III
  • Intrinsic QRS-width ≥ 130 ms with LBBB or ≥ 150 ms without LBBB as measured within 30 days prior to device implant for subjects with NYHA class II
  • Intrinsic QRS-width ≥ 120 ms with LBBB or ≥ 150 ms without LBBB as measured within 30 days prior to device implant for subjects with NYHA class III
  • Subject receives optimal heart failure oral medical therapy (ACE inhibitor and/or ARB and Beta Blockers), and is on a stable medication scheme for at least 1 month prior to enrollment
  • Subject is willing to sign informed consent form
  • Subject is 18 years or older

You may not qualify if:

  • Subject is upgraded from a bradycardia pacemaker to CRT-D
  • Subject receives CRT-D replacement or is upgraded from CRT-P to CRT-D
  • Subject has permanent atrial fibrillation/ flutter or tachycardia.
  • Subject experienced recent myocardial infarction (MI), within 40 days prior to enrollment
  • Subject underwent coronary artery bypass graft (CABG) or valve surgery, within 90 days prior to enrollment
  • Subject is post heart transplantation, or is actively listed on the transplantation list, or has reasonable probability (per investigator's discretion) of undergoing transplantation in the next year
  • Subject is implanted with a left ventricular assist device (LVAD), or has reasonable probability (per investigator's discretion) of receiving a LVAD in the next year
  • Subject is on chronic renal dialysis
  • Subject has severe renal disease (defined as Glomerular Filtration Rate (GFR) \< 30 mL/min/1.73m2)
  • Subject is on continuous or uninterrupted infusion (inotropic) therapy for heart failure (≥ 2 stable infusions per week)
  • Subject has RBBB
  • Subject has permanent 2nd or 3rd degree AV-block
  • Subject has severe aortic stenosis (with a valve area of \< 1.0 cm2 or significant valve disease expected to be operated within study period)
  • Subject has complex and uncorrected congenital heart disease
  • Subject has a mechanical right heart valve
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Academic Medical Center

Amsterdam, Netherlands

Location

Free University

Amsterdam, Netherlands

Location

Medisch Spectrum Twente

Enschede, Netherlands

Location

University Medical Center Groningen

Groningen, Netherlands

Location

Maastricht University Medical Center

Maastricht, Netherlands

Location

University Medical Center Utrecht

Utrecht, Netherlands

Location

Related Publications (2)

  • Salden OAE, Zweerink A, Wouters P, Allaart CP, Geelhoed B, de Lange FJ, Maass AH, Rienstra M, Vernooy K, Vos MA, Meine M, Prinzen FW, Cramer MJ. The value of septal rebound stretch analysis for the prediction of volumetric response to cardiac resynchronization therapy. Eur Heart J Cardiovasc Imaging. 2021 Jan 1;22(1):37-45. doi: 10.1093/ehjci/jeaa190.

    PMID: 32699908DERIVED

  • Maass AH, Vernooy K, Wijers SC, van 't Sant J, Cramer MJ, Meine M, Allaart CP, De Lange FJ, Prinzen FW, Gerritse B, Erdtsieck E, Scheerder COS, Hill MRS, Scholten M, Kloosterman M, Ter Horst IAH, Voors AA, Vos MA, Rienstra M, Van Gelder IC. Refining success of cardiac resynchronization therapy using a simple score predicting the amount of reverse ventricular remodelling: results from the Markers and Response to CRT (MARC) study. Europace. 2018 Feb 1;20(2):e1-e10. doi: 10.1093/europace/euw445.

    PMID: 28339818DERIVED

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood, serum, plasma

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Marc Vos, MD, PhD

    UMC Utrecht

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 24, 2012

First Posted

January 27, 2012

Study Start

February 1, 2012

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

April 18, 2024

Record last verified: 2024-04

Locations

NL(6)