Galectin-3 Blockade in Patients With High Blood Pressure

Mass General Brigham

Status

Completed

Conditions

Hypertension

Treatments

Dietary Supplement: Modified Citrus Pectin (MCP) vs placebo

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT01960946

2015P0023402

K23HL116780 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment

59 patients

Sex

All

Ages

21 to 70 years old

Volunteers

No Healthy Volunteers

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