NCT01949246

Brief Summary

The prospective study aims:

  1. 1.To determine the role and mechanism of biomarkers for prediction of response to CRT
  2. 2.To determine the role of biomarkers and their effect on left ventricular remodeling in patients undergoing CRT.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
221

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2007

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

September 1, 2007

Completed
6 years until next milestone

First Submitted

Initial submission to the registry

September 4, 2013

Completed
20 days until next milestone

First Posted

Study publicly available on registry

September 24, 2013

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

October 3, 2022

Status Verified

September 1, 2022

Enrollment Period

8.3 years

First QC Date

September 4, 2013

Last Update Submit

September 30, 2022

Conditions

Heart Failure

Keywords

Biomarkers

Outcome Measures

Primary Outcomes (1)

  • MACE

    death, HF hospitalization, left ventricular assist device, heart transplant

    2 years

Secondary Outcomes (1)

  • CRT clinical response

    6 months

Study Arms (2)

CRT patients

Patients undergoing CRT device implantation

Healthy patients

Healthy controls

Eligibility Criteria

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

Outpatient or inpatient heart failure patients scheduled for CRT implantation

You may qualify if:

  • Study participant with an approved indication for a CRT or CRT-D system.
  • New York Heart Association (NYHA) Class II, III, or IV Heart Failure unresponsive to drug therapy.
  • EF \< 35%.
  • QRS width \> 120 ms.
  • Study participant receiving optimal medical therapy including ACE inhibitor or Angiotensin Receptor Blocker (ARB), Beta-Blocker, and Diuretic.
  • Study participants with a history of significant congestive decompensation events within the last 12 months.

You may not qualify if:

  • NYHA Class I Heart Failure.
  • Co morbidities (e.g., cancer), which may limit lifespan \< 6 months.
  • Severe aortic stenosis (valve area \< 1.0 cm2).
  • Study participants that received cardiac surgery or intervention (i.e. coronary artery bypass grafting (CABG), valve surgery, angioplasty, arthrectomy) within the preceding 90 days.
  • Study participants with moderate to severe chronic obstructive pulmonary disease (COPD), defined as needing chronic oxygen therapy or recent hospitalization (within 30 days) for COPD flare up.
  • Concurrent pregnancy.
  • Study participants with primary pulmonary hypertension.
  • Study participants on continuous or intermittent infusion therapy for heart failure.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (3)

  • Truong QA, Januzzi JL, Szymonifka J, Thai WE, Wai B, Lavender Z, Sharma U, Sandoval RM, Grunau ZS, Basnet S, Babatunde A, Ajijola OA, Min JK, Singh JP. Coronary sinus biomarker sampling compared to peripheral venous blood for predicting outcomes in patients with severe heart failure undergoing cardiac resynchronization therapy: the BIOCRT study. Heart Rhythm. 2014 Dec;11(12):2167-75. doi: 10.1016/j.hrthm.2014.07.007. Epub 2014 Jul 8.

    PMID: 25014756RESULT

  • Ajijola OA, Chatterjee NA, Gonzales MJ, Gornbein J, Liu K, Li D, Paterson DJ, Shivkumar K, Singh JP, Herring N. Coronary Sinus Neuropeptide Y Levels and Adverse Outcomes in Patients With Stable Chronic Heart Failure. JAMA Cardiol. 2020 Mar 1;5(3):318-325. doi: 10.1001/jamacardio.2019.4717.

    PMID: 31876927DERIVED

  • Bakos Z, Chatterjee NC, Reitan C, Singh JP, Borgquist R. Prediction of clinical outcome in patients treated with cardiac resynchronization therapy - the role of NT-ProBNP and a combined response score. BMC Cardiovasc Disord. 2018 Apr 24;18(1):70. doi: 10.1186/s12872-018-0802-8.

    PMID: 29699498DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Whole Blood

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Jagmeet P Singh

    Massachussetts General Hospital

    PRINCIPAL INVESTIGATOR

  • Quynh A Truong, MD MPH

    Weill Medical College of Cornell University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Jagmeet P Singh, M.D. Ph.D.

Study Record Dates

First Submitted

September 4, 2013

First Posted

September 24, 2013

Study Start

September 1, 2007

Primary Completion

January 1, 2016

Study Completion

January 1, 2016

Last Updated

October 3, 2022

Record last verified: 2022-09

Locations

US(1)