Heart failure Circulatory System Heart failure
Conditions
Interventions
Current interventions as of 27/10/2014:
MCP (6) capsules three times a day (total daily intake 14.4 g) vs matched placebo. The placebo is a microcrystalline cellulose placebo in matchi
Sponsors
Hull and East Yorkshire Hospitals NHS Trust (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients diagnosed with heart failure, who had been or are currently on diuretics, substantiated by a raised NT-pro BNP and /or evidence of left ventricular systolic or diastolic dysfunction 2. Plasma galectin-3 level > 17.8 ng/mL 3. Therapy with an angiotensin converting enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB) and beta-blocker (BB) (unless documented intolerance) for at least 3 months duration. 4. Aged over 18 5. If female, not of childbearing age or, if of childbearing age and sexually active, willing to use birth control.
Exclusion criteria
Exclusion criteria: 1. Current decompensated heart failure 2. Inability to provide informed consent 3. Use of eplerenone or spironolactone within 30 days of randomization or for more than 7 days within the previous 6 months (because they suppress galectin-3 effects and have potassium sparing effects which could increase the risk of hyperkalemia) 4. Pregnant or breast-feeding women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measures as of 27/10/2014: 1. Effect of MCP supplementation on NT-proBNP (primary endpoint of the study). Natriuretic peptides such as NT-proBNP increase in response to myocardial stretch 2. Effect of MCP supplementation on collagen turnover and extracellular remodelling (PICP) Previous primary outcome measures: 1. Effect of MCP supplementation on NT-proBNP (primary endpoint of the study). Natriuretic peptides such as NT-proBNP increase in response to myocardial stretch 2. Effect of MCP supplementation on collagen turnover and extracellular remodeling 3. Global longitudinal strain | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 27/10/2014: 1. Galectin-3, a mediator of heart failure development and progression secondary to myocardial fibrogenesis. Its levels are unaffected by myocardial stretch 2. Effect on microalbuminuria 3. Effect on vascular function and haemodynamics (ENVERDIS with GTN sublingually and NEXFIN) 4. Effect on clinical endpoints will include 6-minute walk distance 5. Effect on ventricular remodelling (with left ventricular end diastolic volume as the main secondary endpoint), and ventricular function ?with the main secondary endpoint as left ventricular global longitudinal strain, which is thought to be more reproducible (with less potential of measurement error) as well as more sensitive than ejection fraction (Pellicori et al. 2013) 6. Nutritional intake and weight change, this is part of safety monitoring to minimise the risk of undernutrition and cardiac cachexia which will be assessed and early nutrition support will be initiated as required Previous secondary outcome measures: 1. Procollagen type I N-terminal propeptide (PINP) - main secondary endpoint of fibrosis 2. Procollagen type III N-terminal peptide (PIIINP) - marker of cardiac collagen synthesis 3. Type I collagen telopeptide (ICTP) - marker of cardiac collagen synthesis 4. Matrix metalloproteinase-1 (MMP-1) - marker of cardiac collagen degradation 5. Tissue inhibitor of metallopeptidase 1 (TIMP1) - marker of cardiac collagen degradation 6. Left ventricular end diastolic volume 7. Ejection fraction | — |
Countries
United Kingdom
Outcome results
None listed