Improving Treatment Personalization of Pulmonary Hypertension Associated With Diastolic Heart Failure
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Changes in Pulmonary Vascular Pressure
研究概览
简要总结
Heart failure with preserved ejection fraction (HFpEF), is one of the leading causes of pulmonary hypertension (PH). Despite the severity of this disease, no established treatments exist for this class of PH. Nebivolol is a drug used in high blood pressure and heart failure, but not used in patients with PH. Due to some additional properties it possesses, the investigators believe nebivolol will improve disease severity in patients with PH associated with HFpEF. The hypothesis of this research study is that nebivolol improves PH severity in patients with HFpEF, as measured by hemodynamic and clinical parameters.
详细描述
This research study will be a prospective, open-label 18-week clinical study of nebivolol in patients with PH associated with HFpEF. Patients will be identified in clinic based on echocardiogram (TTE) and right heart catheterization (RHC) results (both part of standard clinical care) indicating PH and HFpEF.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Adults (≥ 18 years of age) with World Health Organization Group 2 Pulmonary Hypertension (Mean pulmonary artery pressure ≥ 25 mmHg and pulmonary capillary wedge pressure ≥ 15 mmHg)
- •New York Heart Association class II-IV symptoms
- •Left ventricular ejection fraction (LVEF) ≥ 45%
排除标准
- •Other causes of heart failure other than diastolic dysfunction, such as restrictive cardiomyopathy or infiltrative cardiomyopathy
- •Women who are pregnant or nursing
- •Liver cirrhosis,
- •Primary valvular disease
- •Acute coronary syndrome
- •Causes of PH other than that of heart failure, such as: chronic thromboembolic PH, sickle-cell disease, or sarcoidosis
- •Severe bradycardia or greater than 1st degree heart block
- •Decompensated heart failure
- •Current use of a third generation beta-blocker (nebivolol, carvedilol, or labetalol) or high dose of any beta-blockers (greater than 100 mg daily of metoprolol, or equivalent)
研究组 & 干预措施
Nebivolol
Participants will be started at 2.5 mg of nebivolol by mouth daily if on a beta-blocker the dose will start at 5mg, and titrated up to 10 mg daily, as tolerated.
干预措施: Nebivolol (Drug)
结局指标
主要结局
Changes in Pulmonary Vascular Pressure
时间窗: baseline - 18 weeks
Difference between baseline and 18 week mean pulmonary artery pressure and pulmonary artery wedge pressure
次要结局
- Changes in 6-minute Walk Distance(baseline - 18 weeks)