Reversal of Right Ventricular Steatosis in Pulmonary Hypertension
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 2
- 主要终点
- Right ventricular myocardial triglyceride content (by cardiac MRI) in 30 participants with pulmonary hypertension
研究概览
简要总结
The goal of this study is to elucidate the relationship between myocardial right ventricular triglyceride content (steatosis) and right ventricular dysfunction in participants with pulmonary hypertension, and investigate reversibility of this phenotype with omega-3 fatty acid treatment.
详细描述
The investigators propose to treat 30 participants that are identified as having elevated myocardial triglyceride content (defined as greater than 0.50%) on cardiac MRI with 4 grams of omega-3 fatty acids daily for six months with a primary end point of reducing right ventricular steatosis and a secondary endpoint of improving RV systolic function. The investigators hypothesize that right ventricular steatosis by cardiac MRI will be associated with the degree of right ventricular systolic function by cardiac MRI. In the subset of participants with elevated baseline steatosis who are treated with a lipoprotective strategy, the investigators hypothesize that six months of therapy with omega-3 fatty acids will reduce myocardial steatosis and improve right ventricular systolic function.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult men and women > 30 years of age with a diagnosis of pulmonary hypertension (defined as mean pulmonary arterial pressure ≥25 mmHg at rest on right heart catheterization)
排除标准
- •Contraindication to MRI (e.g., metallic hazards or allergy to gadolinium)
- •Renal dysfunction (eGFR < 60 ml/min/1.73m2 as estimated by the Modified Diet in Renal Disease formula)
- •High risk features for nephrogenic systemic fibrosis (solitary kidney or prior renal transplant)
- •Active pregnancy or breastfeeding (determined by urinary pregnancy test before CMR)
- •Weight > 550 lb or waist diameter > 70 cm (limits for our Siemens Verio CMR system)
- •Fish Allergy
结局指标
主要结局
Right ventricular myocardial triglyceride content (by cardiac MRI) in 30 participants with pulmonary hypertension
时间窗: 6 months
次要结局
- Right ventricular ejection fraction (by cardiac MRI) in 30 participants with pulmonary hypertension(6 months)
研究者
Wen-Chih Wu
Chief of Medical
Providence VA Medical Center