The Efficacy of Phosphodiesterase Inhibitors in Patients With Group 2 Pulmonary Hypertension
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Functional capacity of the patients
研究概览
简要总结
The goal of this clinical trial is to test the efficacy of tadalafil in patients with group II pulmonary hypertension with CpcPH with elevated pulmonary vascular resistance (PVR equals or more than 4 WU).
The main question it aims to answer is:
• Can tadalafil improve patients with group II pulmonary hypertension with CpcPH, regarding functional, clinical, biomarker and echocardiographic outcomes? Participants will undergo right heart catheterization (RHC) to make sure they are fulfilling the inclusion criteria of CpcPH, then will be asked to take tadalafil 20 mg for two weeks then 40 mg if tolerated for 12 weeks, then participants will be followed up. Investigators will compare the drug group with the control group.
详细描述
The study aims at studying the efficacy of tadalafil in patients with group 2 pulmonary hypertension with elevated pulmonary vascular resistance guided by RHC. After fulfilling the inclusion criteria, investigators will recruit 48 patients, and do baseline echocardiography for comprehensive right ventricular (RV) study and 6 minute walk test, and then start tadalafil 20 mg then 4mg if tolerated, for 24 patients (drug group). After three months follow up, investigators will follow up the patients regarding RV function and the functional capacity, compared to matched control group.
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
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •group 2 pulmonary hypertension with CpcPH with PVR equals or more than 4 by RHC.
- •NYHA II-III symptoms.
- •Patients should be on HF medical therapy 90 days before enrollment in the study.
排除标准
- •All groups of PH, other than Group 2 PH.
- •Patients with Group 2, but no meeting the predefined hemodynamic criteria for CpcPH (mean PAP more than 20 mmHg, mean PCWP more than 15 mmHg, PVR equals or more than 4 WU).
- •Hypersensitivity, allergy, or intolerable side effects of PDE-5 inhibitors.
- •Contraindication to PDE-5 inhibitors, including current nitrate therapy.
- •Anticipated cardiac resynchronization therapy within 3 months of enrollment.
- •History of heart transplant, ventricular-assist device, or any other solid-organ transplant
- •Recent stroke, myocardial infarction, any coronary intervention; PCI or CABG.
- •Decompensated heart failure.
- •Female subject who is pregnant, breast-feeding, or unwilling to practice an acceptable method of birth control unless postmenopausal or sterile.
- •Unreliability as a study participant, based on the investigator's (or designee's) knowledge of the subject (e.g., alcohol or other substance abuse, inability or unwillingness to adhere to the protocol, documented noncompliance, or vulnerable population)
- •Current enrollment, or enrollment completed <30 days previously, in another investigational drug or device clinical study.
- •Undergoing dialysis for end-stage renal disease.
- •End-stage liver disease comorbidities, limiting exercise tolerance.
- •Morbid obesity (body mass index > 40).
- •Severe peripheral vascular disease with intermittent claudication.
- •Status after amputation of lower extremity(s) at any level.
- •Severe degenerative joint disease preventing normal walking.
- •Cerebrovascular accident with long-term sequelae affecting ability to walk.
研究组 & 干预措施
tadalafil-receiving arm
Patients will take tadalafil for the 12 week period of follow up, in addition to the standard evidence-based therapy for the left heart disease.
干预措施: tadalafil 20 mg then 40 mg if tolerated (Drug)
Tadalafil non-receiving arm
Patients will not take tadalafil for the 12 weeks follow up, only standard evidence-based therapy for the left heart disease.
结局指标
主要结局
Functional capacity of the patients
时间窗: 12 weeks
Six minute walk test, to assess the number of meters the patient can walk within 6 minutes, in be measured in meter unit.
heart failure symptoms
时间窗: 12 weeks
using NYHA classification either 1, 2, 3 or 4
Functional capacity
时间窗: 12 weeks
Six minute walk test, to assess the number of meters the patient can walk within 6 minutes, in be measured in meter unit.
Right sided heart failure manifestations
时间窗: 12 weeks
peripheral edema grade from 0 to 4
次要结局
- Risk profile assessment(12 weeks)
- Left ventricular function(12 weeks)
- Rate of hospitalization(12 weeks)
- Right ventricular size(12 weeks)
- Right ventricular function(12 weeks)
- Pulmonary artery pressure(12 weeks)
- NT-proBNP(12 weeks)
- Left ventricular diastolic function(12 weeks)
- Right-sided heart failure manifestations(12 weeks)
- Left ventricular systolic function(12 weeks)
- right ventricular function(12 weeks)
研究者
Marina Awad
Assistant Lecturer
Beni-Suef University