Galectin-3 Blockade in Patients With High Blood Pressure
This study will investigate if Modified Citrus Pectin (MCP) can help people with high blood pressure. MCP is a dietary supplement that is derived from plants, and therefore is not subject to approval by the U.S. Food and Drug Administration (FDA). However, MCP has been deemed as 'generally regarded as safe' by the FDA.
This study will examine whether Modified Citrus Pectin (MCP) can help people with high blood pressure. The study will help understand how MCP may affect the risk for heart disease in patients with high blood pressure.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
|Official Title:||Galectin-3 Inhibition With Modified Citrus Pectin in Hypertension|
- Change in markers of collagen metabolism [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]Primary aim will be change in markers of collagen metabolism (PICP, PIIICP, ICTP, TIMP-1) in MCP versus placebo groups over 6 months of treatment.
- Change in galectin-3 level [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]Changes in galectin-3 level from baseline until 6 months will be compared between MCP and placebo groups
- Changes in cardiac structure and function [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]Changes in cardiac structure and function will be examined using 2-D echocardiography and tissue Doppler imaging. This will include changes in left ventricular mass, dimensions, left atrial size, and left ventricular diastolic function.
- Changes in arterial stiffness [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]We will examine changes in arterial stiffness (including augmentation index, carotid-femoral pulse-wave velocity) from baseline to 6 months in the MCP and placebo groups
|Study Start Date:||October 2013|
|Estimated Primary Completion Date:||October 2015 (Final data collection date for primary outcome measure)|
Active Comparator: Modified Citrus Pectin (MCP)
Dietary Supplement: Modified Citrus Pectin (MCP, PectaSol-C), 5 grams by mouth three times a day
Dietary Supplement: Modified Citrus Pectin (MCP)
5 grams by mouth three times a day
Placebo Comparator: Placebo
Matched placebo 5 grams by mouth three times a day
Gal-3 appears to be a potential mediator of cardiac fibrosis, preceding the development of clinical heart failure. In this study, we seek to identify individuals at risk for the development of heart failure based on clinical hypertension and elevated Gal-3 concentrations. Participants will be randomized to receive a Gal-3 inhibitor (MCP) or placebo. The primary outcome will be the effect on collagen metabolism, and secondary outcomes include echocardiographic measures of cardiac structure and function, and non-invasive measures of vascular function.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01960946
|Contact: Jennifer E Ho, MDfirstname.lastname@example.org|
|United States, Massachusetts|
|Boston University Medical Center||Recruiting|
|Boston, Massachusetts, United States, 02118|
|Principal Investigator: Jennifer E Ho, MD|
|Principal Investigator:||Jennifer E Ho, MD||Boston University|