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| ID | Type | Description | Link |
|---|---|---|---|
| K23HL116780 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Modified Citrus Pectin (MCP) | Active Comparator | Dietary Supplement: Modified Citrus Pectin (MCP, PectaSol-C), 5 grams by mouth three times a day |
|
| Placebo | Placebo Comparator | Matched placebo 5 grams by mouth three times a day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Modified Citrus Pectin (MCP) vs placebo | Dietary Supplement | 5 grams by mouth three times a day |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jennifer E Ho, MD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33532663 | Result | Lau ES, Liu E, Paniagua SM, Sarma AA, Zampierollo G, Lopez B, Diez J, Wang TJ, Ho JE. Galectin-3 Inhibition With Modified Citrus Pectin in Hypertension. JACC Basic Transl Sci. 2021 Jan 6;6(1):12-21. doi: 10.1016/j.jacbts.2020.10.006. eCollection 2021 Jan. |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| D005355 | Fibrosis |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C586814 | citrus pectin |
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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 |