Selective Coronary Vein Sampling in Left Bundle Branch Block and CRT
MicroCRT
1 other identifier
interventional
70
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable heart-failure
Started Apr 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 24, 2014
CompletedFirst Posted
Study publicly available on registry
March 24, 2015
CompletedStudy Start
First participant enrolled
April 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedMarch 24, 2015
March 1, 2015
1.1 years
October 24, 2014
March 18, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Levels of Various biomarkers measured from different coronary veins at rest and following exertion both pre CRT implant and at 6 months
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
Study Arms (6)
Group 1
EXPERIMENTAL40 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.
Group 2
ACTIVE COMPARATORA 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.
Group 3
ACTIVE COMPARATORA 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.
Group A
EXPERIMENTAL10 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.
Group B
ACTIVE COMPARATOR5 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
Group C
ACTIVE COMPARATOR5 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
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Pregnancy
- Moderate to severe aortic valve disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Guy's and St Thomas Hospital Trust
London, Se1 7EH, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 24, 2014
First Posted
March 24, 2015
Study Start
April 1, 2015
Primary Completion
May 1, 2016
Study Completion
December 1, 2016
Last Updated
March 24, 2015
Record last verified: 2015-03