Heart Failure Clinical Trial
— MicroCRTOfficial 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
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.
Status | Not yet recruiting |
Enrollment | 70 |
Est. completion date | December 2016 |
Est. primary completion date | May 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science
Country | Name | City | State |
---|---|---|---|
United Kingdom | Guy's and St Thomas Hospital Trust | London |
Lead Sponsor | Collaborator |
---|---|
Guy's and St Thomas' NHS Foundation Trust |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No |
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