Galectin-3 Blockade in Patients With High Blood Pressure

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

59 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Study Completion Date

2018-08-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Conditioned Placebo Effects and Treatment of Hypertension

NCT00269269

Cardiovascular Diseases Heart Diseases Hypertension

COMPLETED PHASE2

Evaluation of Intestinal Microbiota Manipulation to Treat Resistant Hypertension

NCT04398693

Hypertension Resistant Hypertension

UNKNOWN NA

Benefit of IQP-AS-118 on Blood Pressure and LDL-cholesterol

NCT02871362

Blood Pressure Low Density Lipoprotein Cholesterol Level

COMPLETED NA

Investigate the Effectiveness of KEFPEP® on Regulating High Blood Pressure

NCT06393621

Prehypertension

COMPLETED NA

Placebo Effects on Blood Pressure

NCT00570271

Blood Pressure

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hypertension

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Modified Citrus Pectin (MCP)

Dietary Supplement: Modified Citrus Pectin (MCP, PectaSol-C), 5 grams by mouth three times a day

Group Type ACTIVE_COMPARATOR

Modified Citrus Pectin (MCP) vs placebo

Intervention Type DIETARY_SUPPLEMENT

5 grams by mouth three times a day

Placebo

Matched placebo 5 grams by mouth three times a day

Group Type PLACEBO_COMPARATOR

Modified Citrus Pectin (MCP) vs placebo

Intervention Type DIETARY_SUPPLEMENT

5 grams by mouth three times a day

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Modified Citrus Pectin (MCP) vs placebo

5 grams by mouth three times a day

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

MCP PectaSol-C

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

21 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No