Galectin-3 Blockade in Patients With High Blood Pressure

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Boston Medical Center
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Boston Medical Center
ClinicalTrials.gov Identifier:
NCT01960946
First received: October 9, 2013
Last updated: August 25, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention
Hypertension
Dietary Supplement: Modified Citrus Pectin (MCP)

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Boston Medical Center:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 80
Study Start Date: October 2013
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Other Names:
  • MCP
  • PectaSol-C
Placebo Comparator: Placebo
Matched placebo 5 grams by mouth three times a day

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.

  Eligibility

Ages Eligible for Study:   21 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 < 38% in men and < 36% in women
  • Use of chelating agents
  • History of 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 >5.0
  • Anticipated inability to complete or comply with study protocol
  • History of angioedema
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01960946

Contacts
Contact: Jennifer E Ho, MD jennifer.ho@bmc.org

Locations
United States, Massachusetts
Boston University Medical Center Recruiting
Boston, Massachusetts, United States, 02118
Principal Investigator: Jennifer E Ho, MD         
Sponsors and Collaborators
Boston Medical Center
Investigators
Principal Investigator: Jennifer E Ho, MD Boston University
  More Information

No publications provided

Responsible Party: Boston Medical Center
ClinicalTrials.gov Identifier: NCT01960946     History of Changes
Other Study ID Numbers: H-32285, 1K23HL116780
Study First Received: October 9, 2013
Last Updated: August 25, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Boston Medical Center:
Hypertension
Galectin 3
Fibrosis
Vascular Stiffness
Echocardiography

Additional relevant MeSH terms:
Hypertension
Cardiovascular Diseases
Vascular Diseases
Pectin
Antidiarrheals
Gastrointestinal Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014