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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
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
Dr Christopher McAloon, University Hospitals Coventry and Warwickshire NHS Trust

Brief Summary:

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

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Study Type : Observational
Estimated Enrollment : 58 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Group/Cohort Intervention/treatment
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




Primary Outcome Measures :
  1. Clinical Response [ Time Frame: 6 months ]

    Two of three criteria must be fulfilled to be defined as a clinical response:

    1. New York Heart Association (NYHA) > 1 class reduction from baseline
    2. Minnesota Living with Heart Failure Questionnaire (MLHFQ) score < 5 from baseline
    3. 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.



Secondary Outcome Measures :
  1. Major Adverse Cardiovascular Outcomes [ Time Frame: 12 months ]
    Composite score of all-cause mortality and first heart failure hospitalisation (admission requiring intravenous diuretics)

  2. Echocardiographic Response [ Time Frame: 6 months ]
    ≥15% reduction in left ventricular end-systolic volume


Biospecimen Retention:   Samples Without DNA
Participants with have peripheral and coronary sinus samples taken for plasma and serum.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Chronic heart failure patients who have been referred for and meet national criteria for Cardiac Resynchronization Therapy implants
Criteria

Inclusion Criteria:

  1. Age > 18 years
  2. Left ventricular ejection fraction ≤35% on echocardiography
  3. NYHA Class III/IV symptoms or milder symptoms with:

    • NYHA I (LVEF <35% and QRS>150msec on resting ECG)
    • NYHA II (LVEF <35% with either QRS>150msec or QRS 120-149msec with Left Bundle Branch Block on resting ECG)
  4. Optimal medical therapy for heart failure that the patient tolerates (ACEi, Beta-Blocker, Mineralocorticoid) for > 3 months
  5. QRS duration ≥120-149msec with LBBB on resting ECG or QRS duration >150msec on resting ECG
  6. Patient consent to participation in the study

Exclusion Criteria:

  1. Acute heart failure decompensation < 6/52 before implant
  2. Significant cognitive impairment
  3. Acute coronary syndrome < 6/52 before implant
  4. Chronic kidney disease stage V (requiring dialysis)
  5. Terminal illness with likely survival < 1 year after implant

Post Procedure Exclusions:

1. Failure of procedure (e.g. coronary sinus anatomy) 2. Complication resulting in poor/ none biventricular pacing (e.g. phrenic nerve stimulation, lead displacement/ damage)

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Information from the National Library of Medicine

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


Locations
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United Kingdom
University Hospital Coventry and Warwickshire
Coventry, Warwickshire, United Kingdom, CV2 2DX
Sponsors and Collaborators
University Hospitals Coventry and Warwickshire NHS Trust
Medtronic
Investigators
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Principal Investigator: Faizel Osman, MD FRCP FESC University Hospital Coventry and Warwickshire

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Dr Christopher McAloon, Cardiology Research Fellow, University Hospitals Coventry and Warwickshire NHS Trust
ClinicalTrials.gov Identifier: NCT02541773     History of Changes
Other Study ID Numbers: version 10 20 Jan 2016
First Posted: September 4, 2015    Key Record Dates
Last Update Posted: March 9, 2016
Last Verified: September 2015

Keywords provided by Dr Christopher McAloon, University Hospitals Coventry and Warwickshire NHS Trust:
Chronic Heart Failure
Cardiac Resynchronization Therapy
Vascular Biomarker
miRNA
Extracellular Matrix
Brain Natruetic Peptide
Growth Degradation Factor-15
Body Composition

Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases