EUCTR2010-018436-41-AT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
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:
- •o in patients with sinus rhythm: either abnormal relaxation (E/A wave ratio <1) or diastolic stiffness (E/A-wave ratio >2)
- •o in patients with atrial fibrillation: E-wave deceleration time <150 ms
- •4. NYHA class >I
- •5. Serum NT-proBNP >220 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 30 days.
- •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 defined by the requirement for surgical repair apart from tricuspid valvular insufficiency due to PH.
- •3.Presence of myocardial ischemia as indicated by angina pectoris, stress test, or coronary angiography.
- •4.Unstable angina or myocardial infarction within the last 3 months.
- •5. Revascularization procedure (percutaneous coronary intervention [PCI] or coronary artery
- •bypass graft [CABG]) within the last 3 months.
- •6. Cardiac surgery within the last 3 months, or transcatheter aortic valve implantation within
- •30 days, or ongoing prolonged hospitalization after cardiac surgery.
- •7. Clinical instability with cardiac decompensation or clinical constellation at the time of randomization, characterized by any of the following:
- •a. Pleural or pericardial effusion requiring pleura- / pericardiocentesis
- •b. Need for IV diuretic treatment or evidence for volume overload
- •c. Admission to emergency or intensive care unit
- •d. Need for non-study procedures including stress testing or contrast media exposure that could confound the results and stress the patient
- •8. Critical carotid artery stenosis
- •9. Hypertrophic cardiomyopathy, amyloidosis, or cardiomyopathy associated with storage disease
- •10. Constrictive pericarditis
- •11. Resting heart rate while awake <50 bpm or >110 bpm
- •12. Uncontrolled arterial hypertension (Systolic blood pressure >180 mmHg and /or diastolic blood pressure >110 mmHg) or arterial hypertension not optimally managed according to current guidelines and requiring immediate antihypertensive treatment.
- •Exclusion criteria related to disorders in organ function:
- •1.Clinically r
研究者
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