Clinical trial NCT01960946: Galectin-3 Blockade in Patients With High Blood Pressure
Official title: Galectin-3 Inhibition With Modified Citrus Pectin in Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Keywords: Hypertension
Galectin 3
Fibrosis
Vascular Stiffness
Echocardiography
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2013-10-11
Enrollment: 59
Sex: ALL
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in markers of collagen metabolism
timeFrame: Baseline and 6 months
Secondary outcomes:
measure: Change in galectin-3 level
timeFrame: Baseline and 6 months
measure: Changes in cardiac structure and function
timeFrame: Baseline and 6 months
measure: Changes in arterial stiffness
timeFrame: Baseline and 6 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Jennifer E Ho, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.