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Keep this study
Lead
Medical University of Vienna
Age
18–80
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.)
Postmenopausal women (i.e. last menstrual bleeding at least 2 years before randomization)
Women with bilateral tubal ligation
Women with bilateral ovariectomy
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.
Able to understand and follow instructions and to participate in the study for its entire duration
Written informed consent
You may not be if
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
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
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 to 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
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)
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 study
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
Clareo Health | Pharmacodynamic Effects of Riociguat in Pulmonary Hypertension and Heart Failure With Preserved Ejection Fraction
