Novel Vascular Biomarkers Behaviour and Clinical Value in Heart Failure and CRT (COVERT-HF)
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|ClinicalTrials.gov Identifier: NCT02541773|
Recruitment Status : Unknown
Verified September 2015 by Dr Christopher McAloon, University Hospitals Coventry and Warwickshire NHS Trust.
Recruitment status was: Active, not recruiting
First Posted : September 4, 2015
Last Update Posted : March 9, 2016
The purpose of this study is to understand the behaviour of certain blood markers in patients with heart failure who undergo a cardiac device implantation procedure called cardiac resynchronization therapy (CRT). CRT is an effective treatment for heart failure, but up to 30% of people do not respond and have poor outcomes (1,2). Despite extensive investigation, identifying these patients continues to be a challenge. The study intends to describe the changes in these blood markers before and after CRT and to examine any potential clinical value.
The idea behind the study is that these blood markers alter in heart failure and change with CRT implantation. Furthermore the pattern of marker expression before implant and after may predict response and outcome.
|Condition or disease||Intervention/treatment|
|Chronic Heart Failure||Device: Cardiac Resynchronisation Therapy|
Show Detailed Description
|Study Type :||Observational|
|Estimated Enrollment :||58 participants|
|Official Title:||The Characterisation of Vascular Biomarkers Before and After Cardiac Resynchronization Therapy in Patients With Chronic Heart Failure and Their Role in Predicting Response|
|Study Start Date :||November 2013|
|Estimated Primary Completion Date :||June 2016|
|Estimated Study Completion Date :||June 2016|
Chronic Heart Failure Patients
Undergoing CRT implantation, all will be observed for 6 months and will be defined at the end of the observation period as responder or non-responder
Device: Cardiac Resynchronisation Therapy
Routine implantation of CRT - part of standard of care
- Clinical Response [ Time Frame: 6 months ]
Two of three criteria must be fulfilled to be defined as a clinical response:
- New York Heart Association (NYHA) > 1 class reduction from baseline
- Minnesota Living with Heart Failure Questionnaire (MLHFQ) score < 5 from baseline
- Six minute walk test (6MWT) increase in baseline distance by 10%
Mortality or heart transplantation within 6 months of implant will be defined as a non-response.
- Major Adverse Cardiovascular Outcomes [ Time Frame: 12 months ]Composite score of all-cause mortality and first heart failure hospitalisation (admission requiring intravenous diuretics)
- Echocardiographic Response [ Time Frame: 6 months ]≥15% reduction in left ventricular end-systolic volume
Biospecimen Retention: Samples Without 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): NCT02541773
|University Hospital Coventry and Warwickshire|
|Coventry, Warwickshire, United Kingdom, CV2 2DX|
|Principal Investigator:||Faizel Osman, MD FRCP FESC||University Hospital Coventry and Warwickshire|