Galectin-3 Blockade in Patients With High Blood Pressure
| Status: | Active, not recruiting |
|---|---|
| Conditions: | High Blood Pressure (Hypertension) |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 21 - 70 |
| Updated: | 3/9/2019 |
| Start Date: | October 2013 |
| End Date: | October 2020 |
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.
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.
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.
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
We found this trial at
1
site
185 Cambridge Street
Boston, Massachusetts 02114
Boston, Massachusetts 02114
617-724-5200
Principal Investigator: Jennifer E Ho, MD
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