Cardiometabolic Disease and Pulmonary Hypertension
试验速览
- 阶段
- 早期 1 期
- 状态
- 终止
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Pulmonary Vascular Hemodynamics (Rest)
研究概览
简要总结
This study will investigate if metformin can help people with obesity and high pressures inside their lung blood vessels. Metformin is approved by the U.S. Food and Drug Administration (FDA) to treat diabetes, but metformin is not approved by the FDA to treat pulmonary hypertension.
This study will examine whether Metformin will improve the high pressure inside lung blood vessels in people who are obese. The study will help understand the effect of metformin on pressures inside lung blood vessels.
详细描述
Obesity can predispose people to develop high pressures inside their lung blood vessels, a condition called pulmonary hypertension, Pulmonary hypertension in turn, can lead to shortness of breath and other health complications such as heart failure. In this study, we seek to identify individuals at risk for the development of high pressures inside lung vessels based on BMI and dyspnea grade 1.
Participants will be screened by echocardiography to estimate pulmonary pressures. Potential participants will undergo invasive cardiopulmonary exercise testing with hemodynamic monitoring, in order to identify individuals with abnormal pulmonary vascular function either at rest or during exercise. Patients who have undergone clinically-indicated cardiopulmonary exercise testing and meet inclusion/exclusion criteria will also be recruited. Those with abnormal pulmonary vascular function will be randomized to receive Metformin or placebo for a total of 3 months under an IND exemption. The primary outcomes include the effect on pulmonary vascular function at rest and during exercise. Secondary outcomes include change in pulmonary artery endothelial cell phenotypes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 30-80 years
- •History of obesity and current BMI ≥ 25 kg/ m2 for study volunteers or BMI ≥ 25 kg/ m2 for those with clinically indicated CPET or known HFpEF
- •History of Dyspnea (Grade 1 or more)
- •Able to provide informed consent and willing to comply with study
排除标准
- •History of diabetes mellitus
- •History of primary pulmonary arterial hypertension
- •History of moderate to severe COPD
- •History of severe Obstructive Sleep apnea
- •History of renal disease (eGFR< 45 mL/min/1.732)
- •History of severe liver disease
- •History of cardiovascular disease (recent heart attack or stroke) except known HFpEF
- •History of blood clot in lung
- •History of Splenectomy
- •History of Active Cancer
- •Platelets count of < 75,000
- •International normalized ration (INR) of > 1.5
- •History of recent anemia (HB < 9g/dL)
- •Current use of Metformin
- •Prior LVEF < 50% on echocardiogram
- •Indication of severe valvular disease on echo
- •Pregnant or planning to become pregnant in next 4 months
- •History of HIV infection
研究组 & 干预措施
Metformin
Metformin: 500mg twice daily for 1 week, followed by 1g twice daily for a total of 3 months.
干预措施: Metformin (Drug)
Placebo
Placebo: 500 mgh twice daily for 1 week, followed by 1g twice daily for a total of 3 months.
干预措施: Placebo (Drug)
结局指标
主要结局
Pulmonary Vascular Hemodynamics (Rest)
时间窗: Baseline and 3 months
The metformin and placebo groups will be compared with respect to resting mean pulmonary artery pressure (mmHg)
Pulmonary Vascular Hemodynamics (Exercise)
时间窗: Baseline and 3 months
The metformin and placebo groups will be compared with respect to augmentation of mean pulmonary artery pressure divided by augmentation of cardiac output during cardiopulmonary exercise testing (change in mean PAP divided by change in cardiac output from rest to peak exercise)
次要结局
- Effect on Pulmonary Artery Endothelial Cell Phenotypes(baseline and 3 months)
研究者
Jennifer En-Sian Ho M.D.
Assistant Physician in Medicine
Massachusetts General Hospital