Galectin-3 Blockade in Patients With High Blood Pressure

Not Applicable

Completed

• Conditions: Hypertension

• Registration Number: NCT01960946
• Lead Sponsor: Massachusetts General Hospital

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2013-10
• Study First Submitted: 2013-10-09
• Study First Submitted QC: 2013-10-09
• Study First Posted: 2013-10-11
• Primary Completion: 2018-08-30
• Study Completion: 2018-08-30
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-17
• Last Update Posted: 2021-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 59

Inclusion Criteria

• Age 21-70 years
• Physician diagnosed hypertension on stable therapy for 3 months
• Elevated galectin-3 level (above sex-specific median based on Framingham Heart Study measures)
• Able to understand the protocol and provide informed consent in English

Exclusion Criteria

• Uncontrolled hypertension, defined as systolic blood pressure > 170mmHg, diastolic blood pressure > 100mmHg
• Evidence of secondary hypertension
• History of heart failure, coronary artery disease, stroke, atrial fibrillation
• Left ventricular ejection fraction < 45% on echocardiography
• Use of aldosterone antagonists
• History of liver cirrhosis
• History of pulmonary fibrosis
• Kidney dysfunction, defined as estimated glomerular filtration rate < 45 ml/min/1.73m2
• Anemia, defined as hematocrit < 37% in men and < 34% in women
• Use of chelating agents
• History of Active cancer or malignancy
• Known pregnancy, those unwilling to avoid pregnancy during the course of the study, or women currently breastfeeding
• Hyperkalemia on screening labs, defined as potassium >5.2
• Anticipated inability to complete or comply with study protocol
• History of angioedema

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in markers of collagen metabolism	Baseline and 6 months	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.

Secondary Outcome Measures

Name	Time	Method
Changes in arterial stiffness	Baseline and 6 months	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
Change in galectin-3 level	Baseline and 6 months	Changes in galectin-3 level from baseline until 6 months will be compared between MCP and placebo groups
Changes in cardiac structure and function	Baseline and 6 months	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.

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States