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Selective Coronary Vein Sampling in Left Bundle Branch Block and CRT (MicroCRT)

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ClinicalTrials.gov Identifier: NCT02396875
Recruitment Status : Unknown
Verified March 2015 by Guy's and St Thomas' NHS Foundation Trust.
Recruitment status was:  Not yet recruiting
First Posted : March 24, 2015
Last Update Posted : March 24, 2015
Sponsor:
Information provided by (Responsible Party):
Guy's and St Thomas' NHS Foundation Trust

Brief Summary:
Cardiac resynchronisation therapy (CRT) prolongs the life and improves the symptoms in patients with heart failure and electrical dyssynchrony. 30-50% of patients do not improve with the treatment which is both expensive and not without complication. Despite much research, we cannot accurately predict who will not respond. Furthermore, most heart failure patients gets symptoms on exercise and most studies have examined patients at rest. We propose to investigate the effect of exercise on different parts of the left ventricle by sampling various biomarkers of metabolism, myocardial injury and gene expression. We will then repeat the protocol following device insertion to look for changes. This novel work will require a small cohort of patients with heart failure and no electrical dyssynchrony and normal patients to act as controls. We will also measure novel biomarkers at different venous sites relating to different parts of the myocardium to determine whether they can be used to prognosticate or even predict response to CRT.

Condition or disease Intervention/treatment Phase
Heart Failure Procedure: Blood sampling and exercise protocol pre and post CRT implant Procedure: Peripheral blood sampling Procedure: Central blood sampling pre and post CRT implant Procedure: Central blood sampling on one occasion and exercise protocol and 6 month peripheral sampling Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Selective Coronary Vein Sampling in Dyssynchronous Heart Failure and Cardiac Resynchronisation Therapy to Assess Physiological Response to Exercise and Characterise Regional Release of Novel Biomarkers
Study Start Date : April 2015
Estimated Primary Completion Date : May 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
Experimental: Group 1
40 patients undergoing CRT will have venous samples taken from two CS tributaries, peripheral venous and peripheral arterial sites at the time of CRT insertion at the time of device implant. Blood samples will be analysed for metabolites and novel biomarkers They will then undergo repeat sampling at 6 months to assess for changes in the biomarker profile including CS sampling.
Procedure: Central blood sampling pre and post CRT implant
Active Comparator: Group 2
A control arm of 15 patients with heart failure and no dyssynchrony will undergo peripheral venous sampling for novel biomarkers and this will be repeated at 6 months. These samples will allow for control against the dyssynchronous heart failure group and also for temporal changes in biomarker expression.
Procedure: Peripheral blood sampling
Active Comparator: Group 3
A control arm of 15 patients with normal hearts will undergo peripheral venous sampling for novel biomarkers and this will be repeated at 6 months. These samples will allow for control against the dyssynchronous heart failure group and also for temporal changes in biomarker expression.
Procedure: Peripheral blood sampling
Experimental: Group A

10 patients from Group 1

On the day preceding the CRT implant will attend hospital for a temporary invasive catheter study. The patient will have a radial sheath positioned in the arterial system. A pacing protocol will be performed using a pacing wire inserted into the right atrium. Coronary sinus venous blood sampling will be performed using a catheter placed via the femoral or internal jugular vein. At the chief investigator's discretion a specially designed exercise bicycle that allow supine exercise in the catheter lab will be used rather than the atrial pacing wire.

6 months post implant the patients will return to the catheter laboratory for a further study. This will repeat the protocol but with the device having been on for 6 months. This will require further study as described above.

Procedure: Blood sampling and exercise protocol pre and post CRT implant
Active Comparator: Group B

5 patients form Group 2.

Patients will undergo a pacing or exercise protocol and have venous, coronary sinus and arterial blood sampled. They will revert to Group 2 for 6 month follow up

Procedure: Central blood sampling on one occasion and exercise protocol and 6 month peripheral sampling
Active Comparator: Group C

5 patients form Group 3

Patients will undergo a pacing or exercise protocol and have venous, coronary sinus and arterial blood sampled. They will revert to Group 3 for 6 month follow up

Procedure: Central blood sampling on one occasion and exercise protocol and 6 month peripheral sampling



Primary Outcome Measures :
  1. Levels of Various biomarkers measured from different coronary veins at rest and following exertion both pre CRT implant and at 6 months [ Time Frame: 2 years ]
    Biomarkers and metabolites to be assessed include but are not limited to O2, lactate, glucose, CKMB, hs trop, galectin3, Soluble St2, Nt proBNP, cardiac myosin binding protein C, 10 different micro RNA associated with myocardial stress/damage



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Group 1/A:

-Scheduled for CRT implant

Group 2/B -Heart failure without electrical dyssynchrony.

Group B:

-Scheduled for angiography for clinical grounds

Group 3/C -Patients without known heart disease

Group C:

-Scheduled for clinical angiography and found to have normal coronary arteries

Exclusion Criteria:

  • Pregnancy
  • Moderate to severe aortic valve disease

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): NCT02396875


Contacts
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Contact: Christopher Rinaldi, MD MBBS aldo.rinaldi@gstt.nhs.uk
Contact: simon claridge, LLB MBBS simon.claridge@kcl.ac.uk

Locations
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United Kingdom
Guy's and St Thomas Hospital Trust Not yet recruiting
London, United Kingdom, Se1 7EH
Contact: Simon Claridge, MBBS LLB       simon.claridge@kcl.ac.uk   
Contact: Reza Razavi, MBBS MD       reza.razavi@kcl.ac.uk   
Principal Investigator: Christopher Rinaldi, MBBS MD         
Sponsors and Collaborators
Guy's and St Thomas' NHS Foundation Trust

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Responsible Party: Guy's and St Thomas' NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT02396875     History of Changes
Other Study ID Numbers: 14/LO/1765
First Posted: March 24, 2015    Key Record Dates
Last Update Posted: March 24, 2015
Last Verified: March 2015
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases