Evaluation of the Cardiac and Metabolic Effects of Dapagliflozin in Heart Failure With Preserved Ejection Fraction (CAMEO-DAPA): A Phase II, Prospective, Double-Blind Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Pulmonary Capillary Wedge Pressure (PCWP) at Maximal Exercise
研究概览
简要总结
The purpose of this study is to determine whether treatment with Dapagliflozin (DAPA) for 6 months will improve pulmonary capillary wedge pressure (PCWP) during exercise in heart failure/preserved ejection fraction (HFpEF) and improve cardiac metabolism.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent prior to any study specific procedures.
- •Male or female.
- •Symptoms of dyspnea (NYHA II-III) with no non-cardiac or ischemia explanation.
- •EF ≥ 50% + BMI ≥ 30 kg/m^2
- •Elevated pulmonary capillary wedge pressure (PCWP) during exercise (≥ 25 mmHg) ascertained at Visit
- •Patients that have consented to study procedures but do not meet this invasive criterion will be considered as screen failures and will not be randomized .
排除标准
- •Type I diabetes.
- •Type II diabetes with poor control (HgbA1C ≥ 10%).
- •Recent hospitalization (< 30 days) or revascularization (< 90 days).
- •Primary cardiomyopathy (such as amyloid).
- •Constrictive pericarditis.
- •Dyspnea due to primary lung disease or myocardial ischemia in the opinion of the investigator.
- •Severe anemia (hemoglobin < 9gm/dl.
- •Significant left-sided valvular heart disease (> mild stenosis, > moderate regurgitation),
- •Severe kidney disease (estimated glomerular filtration rate (GFR) < 30) or liver disease,
研究组 & 干预措施
Dapagliflozin Group
Subjects with HFpEF will take the study drug dapagliflozin daily
干预措施: Dapagliflozin (Drug)
Placebo Group
Subjects with HFpEF will take a placebo daily
干预措施: Placebo (Drug)
结局指标
主要结局
Pulmonary Capillary Wedge Pressure (PCWP) at Maximal Exercise
时间窗: Baseline, 24 weeks
Pulmonary capillary wedge pressure is a measure of cardiac filling pressure, measured using a high-fidelity micromanometer advanced through the lumen of a fluid-filled catheter during exercise.
Pulmonary Capillary Wedge Pressure (PCWP) at Rest
时间窗: Baseline, 24 weeks
Pulmonary capillary wedge pressure is a measure of cardiac filling pressure, measured using a high-fidelity micromanometer advanced through the lumen of a fluid-filled catheter during rest.
次要结局
- Change in Total Blood Volume(Baseline, 24 weeks)
- Change in Plasma Volume(Baseline, 24 weeks)
- Change in Right Atrial (RA) Pressure at Maximal Exercise(Baseline, 24 weeks)
- Change in Body Weight(Baseline, 24 weeks)
- Change in Right Atrial (RA) Pressure at Rest(Baseline, 24 weeks)
- Change in Mean Pulmonary Arterial Pressure (PA) at Rest(Baseline, 24 weeks)
- Change in Mean Pulmonary Arterial Pressure (PA) at Maximal Exercise(Baseline, 24 weeks)
研究者
Barry Borlaug
Principal Investigator
Mayo Clinic