Galectin-3 Blockade in Patients With High Blood Pressure

February 17, 2021 updated by: Jennifer En-Sian Ho M.D., Massachusetts General Hospital

Galectin-3 Inhibition With Modified Citrus Pectin in Hypertension

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 Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

59

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 68 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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) vs placebo
5 grams by mouth three times a day
Other Names:
  • MCP
  • PectaSol-C
Placebo Comparator: Placebo
Matched placebo 5 grams by mouth three times a day
Dietary supplement: Modified Citrus Pectin (MCP) vs placebo
5 grams by mouth three times a day
Other Names:
  • MCP
  • PectaSol-C

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in markers of collagen metabolism
Time Frame: 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.
Baseline and 6 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

  • Principal Investigator: Jennifer E Ho, MD, Massachusetts General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2013

Primary Completion (Actual)

August 30, 2018

Study Completion (Actual)

August 30, 2018

Study Registration Dates

First Submitted

October 9, 2013

First Submitted That Met QC Criteria

October 9, 2013

First Posted (Estimate)

October 11, 2013

Study Record Updates

Last Update Posted (Actual)

February 21, 2021

Last Update Submitted That Met QC Criteria

February 17, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015P0023402
  • K23HL116780 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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