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

March 18, 2015 updated by: Guy's and St Thomas' NHS Foundation Trust

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

We propose to examine the acute effects of exercise on patients with dyssynchronous electrical activation of the heart and heart failure and to compare the release of novel biomarkers in selective areas of coronary venous drainage by direct cannulation of different veins via the coronary sinus (CS).

The study design will separate patients into a minimally invasive arm (MINARM)and an invasive arm (INARM). The INARM will be recruited from patients in the MINARM.

MINARM

Group 1: 40 patients scheduled for CRT implant Group 2: 15 patients with heart failure and no dyssynchrony Group 3: 15 patients with normal hearts

Group 1:

40 patient undergoing CRT will have venous samples taken from the CS, 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 micro RNA and biomarker profile including CS sampling.

Group 2 and 3

A control arm of 15 patients with heart failure and no dyssynchrony (Group 2) and 15 patients with normal hearts (Group 3) will undergo peripheral venous sampling for 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 micro RNA expression.

10 patient from Group 1 and 5 from Group 2 and 3 will be invited to from part of the INARM at the time of recruitment.

INARM study

Methods:

GROUP A 10 pts with heart failure and dyssynchronous ventricular contraction GROUP B 5 pts with heart failure and no electrical dyssynchrony schedule for either coronary angiography or electrophysiology study.

GROUP C 5 pts schedule for diagnostic coronary angiography or electrophysiology study with normal cardiac function

The exact details of the protocol will vary depending upon the Group:

GROUP A

1 On the day preceding the CRT implant will attend hospital for a temporary invasive catheter study. 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.

3 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 arterial access as described above. This study should take approximately an hour.

GROUP B and C

It is common practice for these patients to have a coronary angiogram to exclude ischaemic heart disease as the cause of their heart failure or chest pain or to have electrophysiology study to determine the mechanism of arrhythmia. If their angiogram is normal,we will perform a pacing protocol (this will be required if they are attending for an electrophysiology study). This will require 2 femoral venous access sites (similar to standard electrophysiological study) to allow temporary atrial pacing and acquisition of blood samples from the coronary sinus. Following the invasive part of the study patients in Group B and C will fall back into Group 2 and 3 of MINARM and attend at 6 month for peripheral blood sampling.

Study Type

Interventional

Enrollment (Anticipated)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guy's and St Thomas' NHS Foundation Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2015

Primary Completion (Anticipated)

May 1, 2016

Study Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

October 24, 2014

First Submitted That Met QC Criteria

March 18, 2015

First Posted (Estimate)

March 24, 2015

Study Record Updates

Last Update Posted (Estimate)

March 24, 2015

Last Update Submitted That Met QC Criteria

March 18, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14/LO/1765

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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