EUCTR2014-003055-60-DE进行中（未招募）1 期
Evaluation of the pharmacodynamic effects of riociguat in subjects with pulmonaryhypertension and heart failure with preserved ejection fraction in a randomized,double-blind, placebo-controlled, parallel-group, multicenter study
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 114
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
- •? 18 to ?80 years of age at the time of informed consent
- •(The lower age limit may be higher if legally required in participating countries.)
- •? Male and female subjects with symptomatic PH and HF-PEF (group 2 / 2.2 of Dana
- •Point classification(4) and WHO class II to IV)
- •(Other groups of PH, especially HF-REF, PAH, CTEPH, must have been ruled out
- •according to accepted diagnostic procedures and guidelines, see section 5.1.2 Exclusion
- •PH-HF-PEF defined as:
- •? LVEF ?50%, diagnosed by echocardiography or left heart catheterization (LHC)
- •within 30 days before randomization
- •? PAPmean ?25 mmHg at rest, measured by RHC
- •? PAWP ?15 mmHg at rest, measured by RHC
- •? Optimized therapy for hypertension
- •? The dose regimen of the background treatment must have been stable for ?30 days
- •before randomization. Diuretic therapy must have been stable for ?1 week.
- •? RHC results for the definite diagnosis of PH not older than 12 weeks at Visit 1. RHC
- •must have been performed in the participating center under standardized conditions.
- •Between the first RHC and study enrollment there must be no changes in concomitant
- •medication which may affect hemodynamic parameters.
- •? CMRI must be performed at Visit 1 (baseline) or must not be older than 12 weeks with
- •all parameters measured as listed in Section 7.3.3
- •? Women are eligible if not of childbearing potential, defined as:
- •? Postmenopausal women (i.e. last menstrual bleeding at least 2 years before
- •randomization)
- •? Women with bilateral tubal ligation
- •? Women with bilateral ovariectomy
- •? Women with hysterectomy
- •or, if of childbearing potential, women are eligible if
- •? A serum pregnancy test is negative at the pre-study visit, and
- •? The woman uses a combination of condoms and a safe and highly effective
- •contraception method (hormonal contraception with implants or combined oral
- •contraceptives, certain intrauterine devices) for the entire duration of the study.
- •? Men enrolled in this study must agree to use adequate barrier birth control measures
- •during the treatment period of the study and inform their sexual partners during the
- •study period and three months beyond their study participation about the possibility of
- •foetal impairment.
- •? Able to understand and follow instructions and to participate in the study for its entire
- •? 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 24
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 90
排除标准
- •? PH in groups other than group 2.2 according to Dana Point classification.(4) In
- •particular, PAH, CTEPH, and HF-REF must have been ruled out according to accepted
- •diagnostic procedures and guidelines.
- •? Cardiac decompensation, with hospitalization or visit to the emergency department,
- •?30 days before randomization
- •? Left heart disease because of ischemic heart disease or dilated cardiomyopathy
- •? Resynchronization therapy at any time
- •? Need for intravenous (IV) diuretics ?30 days before randomization
- •? Treatment with inotropes or IV vasodilators ?30 days before randomization
- •? Pre-treatment with endothelin receptor antagonists (ERAs), phosphodiesterase type 5
- •(PDE5) inhibitors, or prostanoids ?30 days before randomization, or with nitrates
- •?7 days before randomization
- •? Subjects who medically require treatment with drugs that are not in line with the in- or
- •exclusion criteria of this study or that are prohibited concomitant medications (see
- •section 6.8) for this study
- •? Bronchial asthma or chronic obstructive pulmonary disease (COPD) with forced
- •expiratory volume in 1 second (FEV1) ?60% of predicted
- •? Restrictive lung disease with total lung capacity (TLC) ?60% of predicted
- •? Subjects on oxygen therapy
- •? Severe congenital abnormalities of the lung, thorax, or diaphragm
- •? Clinically relevant hepatic dysfunction shown by:
- •? Aspartate aminotransferase (AST) ?3 times the upper limit of normal (ULN) or
- •? Child Pugh stage B and C in cirrhotic subjects
- •? Severe renal impairment (glomerular filtration rate [GFR] <30mL/min/1.73 m2
- •calculated by the Modification of Diet in Renal Disease [MDRD] formula)
- •? Uncontrolled arterial hypertension (SBP ?180 mmHg or diastolic blood pressure [DBP]
- •? SBP ?110 mmHg at baseline
- •? Myocardial disease, such as ischemic or dilative infiltrative myocardial disease (i.e.
- •amyloidosis, hypertrophic cardiomyopathy)
- •? Severe aortic or mitral stenosis, or any such stenosis with indication for surgery
- •? Coronary artery disease with angina of Canadian Cardiovascular Society (CCS) class III
- •or IV or requiring nitrates, unstable angina, or acute myocardial infarction ?90 days
- •before randomization
- •? Reperfusion procedure (percutaneous coronary intervention [PCI] or coronary artery
- •bypass graft [CABG]) ?90 days before randomization, or ?21 days in case of a negative
- •stress test effect after PCI
- •? Stroke with persistent neurological deficit
- •? Subjects positive for human immunodeficiency virus (HIV)
- •? Resting HR while awake of ?50 beats per minute (BPM) or ?105 BPM (in case of atrial
- •fibrillation ?110 BPM)
- •? Participation in another clinical study ?90 days before randomization
- •? Subjects with a medical disorder, condition, or history thereof that in the opinion of the
- •investigator would impair the subject’s ability to participate or complete the 26-week
- •? Subjects with underlying medical disorders with an anticipated life expectancy below
- •2 years because of a non-cardiac disease (e.g. active cancer disease with localized and /
- •or metastasized tumor mass)
- •? Subjects with a history of multiple drug allergies
- •? Subjects with hypersensitivity to the investigational drug or any of the excipients
- •? Previous assignment to treatment during this study
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