EUCTR2010-018436-41-CZ进行中（未招募）不适用
Acute hemoDynamic effects of RIociguat (BAY 63-2521) in patients with puLmonary hypertension Associated with diasTolic heart failurE (DILATE 1): A randomized, double-blind, placebo-controlled, single-dose study in three ascending dose cohorts. - DILATE 1
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 48
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Patients must fulfill all of the following criteria before being included in the study:
- •1.Age = 18 years
- •2.Invasive confirmation of PH associated with DHF documented by right heart catheter measurements of the following parameters:
- •PAPmean = 25 mmHg and
- •PCWP =15 mmHg
- •3.Transthoracic echocardiography
- •confirming preserved ejection fraction with LVEF>50% and
- •evidence for diastolic dysfunction,
- •-either abnormal relaxation (E/A wave ratio <1) or
- •-diastolic stiffness (E/A-wave ratio >2, E-wave deceleration time <115-150 ms)
- •4.NYHA class >I
- •5.Serum NT-proBNP >400 pg/ml
- •6.Written informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 10
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 38
排除标准
- •General exclusion criteria:
- •1.Previous assignment to treatment during this study
- •2.Participation in another clinical trial during the preceding 3 months.
- •3.Pregnant women, or breast feeding women, or women with childbearing potential not using a combination of condoms and a safe and highly effective contraception method (hormonal contraception with implants or combined oral contraceptives, certain intrauterine devices [IUDs]).
- •4.Patients with a medical disorder, condition, or history of such that would impair the patient's ability to participate or complete this study in the opinion of the investigator.
- •5.Patients with a history of severe allergies or multiple drug allergies.
- •6.Known hypersensitivity to study drug or any of the excipients
- •Medication/Treatment exclusion criteria:
- •1.Pre-Treatment within 30 days before randomization with:
- •intravenous (IV) inotropes or IV vasodilators
- •endothelin receptor antagonists (ERAs), PDE5 inhibitors or prostanoids.
- •2.Treatment within 7 days before randomization with NO donors (e.g. nitrates).
- •3.Requirement of treatment with prohibited drugs (see section 6.9) within 48 h after study drug intake.
- •Pulmonary diseases exclusion criteria:
- •1.Bronchial asthma or COPD with Forced Expiratory Volume in one second (FEV1) <60% predicted.
- •2.Restrictive lung disease with Total Lung Capacity <60% predicted.
- •3.Severe congenital abnormalities of the lungs, thorax, or diaphragm.
- •4.O2 therapy
- •5.Clinical or radiological evidence of Pulmo-Veno-Occlusive Disease (PVOD) or Pulmonary Capillary Hemangiomatosis (PCH).
- •Exclusion criteria related to abnormalities in blood gases (measured capillary or arterial):
- •1.SaO2 < 88%
- •2.PaO2 < 55 mmHg
- •Cardiovascular exclusion criteria:
- •1.Pulmonary hypertension of groups other than 2.2 of Dana Point Classification
- •2.Significant valvular heart disease apart from tricuspid valvular insufficiency due to PH
- •3.Presence of angina pectoris of Canadian Cardiovascular Society Classification class 3 to 4 and/or requiring nitrates, unstable angina, or myocardial infarction within the last 3 months.
- •4.Hypertrophic cardiomyopathy, amyloidosis, or cardiomyopathy associated with storage disease
- •5.Constrictive pericarditis
- •6.Resting heart rate while awake <50 bpm or >110 bpm
- •7.Uncontrolled arterial hypertension (Systolic blood pressure >180 mmHg and /or diastolic blood pressure >110 mmHg) or arterial hypertension not optimally treated according to current guidelines [10].
- •8.Systolic blood pressure <95 mmHg.
- •Exclusion criteria related to disorders in organ function:
- •1.Clinically relevant hepatic dysfunction indicated by either:
- •Aspartate aminotransferase (AST) >3 times upper limit normal (ULN)
- •Child Pugh stage B and C in cirrhotic patients
- •2.Severe chronic renal insufficiency (glomerular filtration rate [GFR] GFR <30 mL/min calculated by Modification of Diet in Renal Disease [MDRD] formula).
研究者
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