Biomarkers to Predict CRT Response in Patients With HF (BIOCRT) (BIOCRT)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01949246|
Recruitment Status : Unknown
Verified January 2015 by Jagmeet Singh, Massachusetts General Hospital.
Recruitment status was: Recruiting
First Posted : September 24, 2013
Last Update Posted : January 30, 2015
The prospective study aims:
- To determine the role and mechanism of biomarkers for prediction of response to CRT
- To determine the role of biomarkers and their effect on left ventricular remodeling in patients undergoing CRT.
|Condition or disease|
Cardiac resynchronization therapy (CRT) with biventricular pacing has emerged as a novel treatment for congestive heart failure (CHF) not responsive to optimal drug therapy. CRT is associated with significant improvements in hemodynamics and functional status of patients with CHF. The physiologic effect of CRT is achieved via placing electrical leads in the right and left ventricular walls, and synchronizing ventricular contraction. Over time, this leads to ventricular wall reverse remodeling, and sustained improvements in left ventricular ejection fraction (EF).
Currently, the indications for CRT include end-stage heart failure class II-IV with an EF < 35%, and a QRS duration > 120ms. The QRS duration is used as an indicator of the degree of ventricular electromechanical dyssynchrony, however, a growing number of studies have postulated its inability to predict response to therapy. As a result, other measures of mechanical dyssynchrony are being sought to guide therapy. The vast majority of these studies have examined clinical, cardiac, electrocardiographic, and device-specific indices, however, a widely accepted predictor of response to CRT is lacking.
CRT results in electromechanical synchrony, leading to an improved ejection fraction, exercise tolerance, and reduction of symptoms. Although electrical re-synchronization and intra-procedural hemodynamic improvement are achieved after the device is implanted, the sustained clinical improvement is likely due to ventricular reverse remodeling. A major issue with CRT is that approximately a third of patients receiving devices do not achieve improved clinical or functional status, and fail to undergo changes in ventricular geometry, and ventricular remodeling. It remains unknown whether this is due to abnormalities in the factors involved in lead placement or procedural strategies, geometric remodeling, alterations in cardiac energy metabolism, supply of energy (i.e. coronary blood flow), or inappropriate/inadequate microvascular proliferation.
This study will evaluate a series of biochemical markers implicated in pathophysiology of heart failure, in predicting response to CRT with biventricular pacing.
|Study Type :||Observational|
|Estimated Enrollment :||496 participants|
|Official Title:||Analysis of Circulating Biomarkers in Predicting Response to Cardiac Resynchronization Therapy (CRT) With Biventricular Pacing in Patients With Congestive Heart Failure (BIOCRT)|
|Study Start Date :||September 2007|
|Estimated Primary Completion Date :||January 2016|
|Estimated Study Completion Date :||January 2016|
Patients undergoing CRT device implantation
- MACE [ Time Frame: 2 years ]death, HF hospitalization, left ventricular assist device, heart transplant
- CRT clinical response [ Time Frame: 6 months ]For the definition of a positive response to CRT, patients will be classified according to the HF Clinical Composite Score (CCS). Responders will be defined as those with improved CCS from baseline to 6 month follow-up. Those not meeting this criterion will be considered nonresponders. An outcome panel consisting of two cardiologists will determine the clinical response of each subject based on review of the medical record. If there is disagreement in the assessment of either baseline or follow-up CCS amongst the two cardiologists, a third cardiologist will adjudicate the case.
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01949246
|Contact: Jagemeet P Singh, MD PHDfirstname.lastname@example.org|
|United States, Massachusetts|
|Massachusetts General Hospital||Recruiting|
|Boston, Massachusetts, United States, 02114|
|Contact: Jagmeet P Singh, MD PHD 617-726-4662 email@example.com|
|Principal Investigator: Jagmeet P Singh, MD PHD|
|Principal Investigator:||Jagmeet P Singh||Massachussetts General Hospital|
|Principal Investigator:||Quynh A Truong, MD MPH||Weill Medical College of Cornell University|