Acute Effects of Inorganic Nitrite on Cardiovascular Hemodynamics in Heart Failure With Preserved Ejection Fraction
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Exercise Pulmonary Capillary Wedge Pressure (PCWP)
研究概览
简要总结
Heart failure with preserved ejection fraction (HFpEF) is a major public health problem that has no proven effective treatment. This study assessed the effects of acute nitrite administration on resting and exercise hemodynamics in patients with HFpEF.
详细描述
Subjects were studied on their long-term medications in the post-absorptive state and supine position. Right heart catheterization was performed with simultaneous expired gas analysis at rest and during supine exercise at a 20 Watts workload for 5 minutes. After the first exercise phase (before any drug administration) and after return to steady-state baseline hemodynamic values, subjects were randomized. Study drug or placebo was infused for 5 minutes. After a 10 minute observation period, hemodynamic measurements were repeated at rest, followed by repeat supine exercise at a 20 Watts workload for 5 minutes, identical to the study's first phase. Arterial and venous blood samples and hemodynamic and expired gas data were acquired during each stage of the protocol.
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
- •Scheduled to undergo a cardiac catheterization procedure.
- •Clinical symptoms of shortness of breath and fatigue
- •Normal left ventricular ejection fraction (≥50%)
- •Elevated left ventricular filling pressures at cardiac catheterization (defined as resting pulmonary capillary wedge pressure (PCWP)>15 mmHg and/or PCWP≥25 mmHg during exercise)
排除标准
- •Systolic BP <120 mmHg
- •Prior nitrate therapy (within previous 2 weeks)
- •Glucose 6-phosphate dehydrogenase (G6PD) deficiency
- •Other "non-HFpEF" specific causes of heart failure such as significant valvular disease (>moderate left-sided regurgitation, >mild stenosis), severe pulmonary disease, unstable coronary disease or coronary spasm, primary renal or hepatic disease, constrictive pericarditis, or infiltrative, restrictive, or hypertrophic cardiomyopathies
研究组 & 干预措施
Nitrite
Study drug (NaNO_2 50 mcg/kg/min) will be infused for 5 minutes during the cardiac catheterization procedure.
干预措施: Nitrite (Drug)
Saline
Saline Placebo for Nitrite will be infused for 5 minutes during the cardiac catheterization procedure.
干预措施: Saline Placebo for Nitrite (Drug)
结局指标
主要结局
Exercise Pulmonary Capillary Wedge Pressure (PCWP)
时间窗: during repeat exercise run, approximately 30 minutes after study drug administration
Pulmonary capillary wedge pressure (PCWP) provides an indirect estimate of left atrial pressure (LAP). PCWP is the pressure measured by wedging a pulmonary catheter with an inflated balloon into a small pulmonary arterial branch.
次要结局
- Change in Central Pressures After Study Drug (Resting)(baseline, approximately 30 minutes after study drug administration)
- Change in Heart Rate After Study Drug (Resting)(baseline, approximately 30 minutes after study drug administration)
- Change in Blood Pressure After Study Drug (Resting)(baseline, approximately 30 minutes after study drug administration)
- Change in Pulmonary Vascular Resistance (PVR) After Study Drug (Resting)(baseline, approximately 30 minutes after study drug administration)
- Change in Pulmonary Artery (PA) Compliance After Study Drug (Resting)(baseline, approximately 30 minutes after study drug administration)
- Change in Systemic Vascular Resistance (SVR) After Study Drug (Resting)(baseline, approximately 30 minutes after study drug administration)
- Change in Left Ventricular Stroke Work (LVSW) After Study Drug (Resting)(baseline, approximately 30 minutes after study drug administration)
- Change in Oxygen Consumption (VO_2) After Study Drug (Resting)(baseline, approximately 30 minutes after study drug administration)
- Change in Arteriovenous Oxygen Content Difference After Study Drug (Resting)(baseline, approximately 30 minutes after study drug administration)
- Change in Cardiac Output After Study Drug (Resting)(baseline, approximately 30 minutes after study drug administration)
- Change in Stroke Volume After Study Drug (Resting)(baseline, approximately 30 minutes after study drug administration)
- Change in Central Pressures After Study Drug (Exercise)(baseline, approximately 30 minutes after study drug administration)
- Change in Heart Rate After Study Drug (Exercise)(baseline, approximately 30 minutes after study drug administration)
- Change in Blood Pressure After Study Drug (Exercise)(baseline, approximately 30 minutes after study drug administration)
- Change in PVR After Study Drug (Exercise)(baseline, approximately 30 minutes after study drug administration)
- Change in PA Compliance After Study Drug (Exercise)(baseline, approximately 30 minutes after study drug administration)
- Change in SVR After Study Drug (Exercise)(baseline, approximately 30 minutes after study drug administration)
- Change in LVSW After Study Drug (Exercise)(baseline, approximately 30 minutes after study drug administration)
- Change in Oxygen Consumption (VO_2) After Study Drug (Exercise)(baseline, approximately 30 minutes after study drug administration)
- Change in Arteriovenous Oxygen Difference After Study Drug (Exercise)(baseline, approximately 30 minutes after study drug administration)
- Change in Cardiac Output After Study Drug (Exercise)(baseline, approximately 30 minutes after study drug administration)
- Change in Stroke Volume After Study Drug (Exercise)(baseline, approximately 30 minutes after study drug administration)
研究者
Barry Borlaug
M.D., Associate Professor of Medicine
Mayo Clinic