Galectin-3 Inhibition With Modified Citrus Pectin in Hypertension
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 59
- 试验地点
- 2
- 主要终点
- Change in markers of collagen metabolism
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Change in markers of collagen metabolism
时间窗: Baseline and 6 months
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.
次要结局
- Changes in arterial stiffness(Baseline and 6 months)
- Change in galectin-3 level(Baseline and 6 months)
- Changes in cardiac structure and function(Baseline and 6 months)
研究者
Jennifer En-Sian Ho M.D.
Assistant in Medicine
Massachusetts General Hospital