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Completed

NCT Number: NCT01960946

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.

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Key information

Conditions

Hypertension Cardiovascular Diseases Fibrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

21 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Modified Citrus Pectin (MCP) vs placebo

Dietary Supplement

5 grams by mouth three times a day

Other names: MCP, PectaSol-C

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. 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.

  3. 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

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

Galectin-3 Inhibition With Modified Citrus Pectin in Hypertension

Important dates

Study start
2013
Primary completion
2018
Study completion
2018
First posted
Oct 11, 2013
Registry last updated
Feb 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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