Phase II Clinical Investigation of Oral Nitrite in Patients With Pulmonary Hypertension and Heart Failure With Preserved Ejection Fraction (PH-HFpEF)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Mean Pulmonary Artery Pressure (mPAP) During Submaximal Exercise as Compared Between Placebo and Nitrite
研究概览
简要总结
The main objective of this study is to determine the clinical efficacy of oral inorganic nitrite verses placebo and the therapeutic response with regards to exercise tolerance in patients with pulmonary hypertension and heart failure with preserved ejection fraction (PH-HFpEF).
详细描述
This is a single-center, 22-week double-blind, randomized placebo-controlled cross-over trial of oral nitrite on exercise capacity and hemodynamic measurements in subjects with PH-HFpEF.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Age 18 years and older
- •PH-HFpEF confirmed diagnosis by RHC:
- •Mean Pulmonary Arterial Pressure (mPAP) ≥ 25 mmHg AND
- •Pulmonary capillary wedge pressure (PWCP) ≥ 15 mmHg AND
- •Transpulmonary Gradient (TPG) ≥ 12 mmHg
排除标准
- •Age less than 18 years;
- •SBP > 170 or < 110 mmHg
- •DBP >95 or < 60 mmHg
- •Hemoglobin A1C > 10
- •Positive urine pregnancy test or breastfeeding;
- •Ejection Fraction (EF) < 40%;
- •End-stage malignancy
- •Major cardiovascular event or procedure within 6 weeks prior to enrollment
- •Severe valvular disease
- •Known chronic psychiatric or medical conditions that may increase the risk associated with study participation in the judgment of the investigator, would make the subject inappropriate for entry into this study;
- •Hemoglobin <9 g/dL
- •Serum creatinine > 3.0 mg/dL
- •Receipt of an investigational product or device, or participation in a drug research study within a period of 15 days; RHC < 2 weeks from study screening RHC unless clinically indicated
研究组 & 干预措施
Sodium Nitrite
Study
干预措施: Sodium Nitrite (Drug)
Placebo
Control
干预措施: Placebo Oral Capsule (Drug)
结局指标
主要结局
Mean Pulmonary Artery Pressure (mPAP) During Submaximal Exercise as Compared Between Placebo and Nitrite
时间窗: Baseline and 10 weeks
Mean Pulmonary Artery Pressure measurement at submaximal exercise as compared between Placebo and Oral Nitrite at 10 weeks.
次要结局
- Number of Participants With Different Severities of Heart Failure(10 weeks)
- Change in Right Heart Catheterization (RHC) Hemodynamics - Pulmonary Capillary Wedge Pressure(During Week 10 follow-up at rest and at exercise)
- Change in Right Heart Catheterization (RHC) Hemodynamics - Pulmonary Vascular Resistance(During Week 10 follow-up at rest and at exercise)
- Change in Endurance Exercise Time(10 weeks)
- Change in Severity of Heart Failure(Baseline to Week 10)
- Difference in 6-minute Walk Test(Baseline to 10 weeks)
- Change in Right Heart Catheterization (RHC) Hemodynamics - Trans Pulmonary Gradient(During Week 10 follow-up at rest and at exercise)
- Change in Right Heart Catheterization (RHC) Hemodynamics - Cardiac Output(During Week 10 follow-up at rest and at exercise)
研究者
Michael Risbano
Assistant Professor of Medicine
University of Pittsburgh