Galectin-3 Blockade in Patients With High Blood Pressure

Study Overview
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Brief Summary
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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
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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.

Official Title
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Galectin-3 Inhibition With Modified Citrus Pectin in Hypertension

Conditions
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Hypertension

Intervention / Treatment
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* Dietary Supplement: Modified Citrus Pectin (MCP) vs placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Modified Citrus Pectin (MCP)<br>Dietary Supplement: Modified Citrus Pectin (MCP, PectaSol-C), 5 grams by mouth three times a day | Dietary Supplement: Modified Citrus Pectin (MCP) vs placebo<br>* 5 grams by mouth three times a day<br>* Other names: PectaSol-C;|
| Placebo Comparator: Placebo<br>Matched placebo 5 grams by mouth three times a day | Dietary Supplement: Modified Citrus Pectin (MCP) vs placebo<br>* 5 grams by mouth three times a day<br>* Other names: PectaSol-C;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in markers of collagen metabolism | 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 | 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 | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hypertension, Galectin 3, Fibrosis, Vascular Stiffness, Echocardiography