- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04954742
Effects of Riociguat on RIght VEntricular Size and Function in PAH and CTEPH (RIVERII)
An Open-label, Prospective, Single Centre Study of the Effects of Riociguat on RIght VEntricular Size and Function in Pulmonary Arterial Hypertension and Chronic Thromboembolic Pulmonary Hypertension
Study Overview
Status
Intervention / Treatment
Detailed Description
Right heart size and function are of utmost prognostic importance in PAH/CTEPH. RV performance measured by echocardiography and enlarged RA area have been shown to be independent prognostic factors in PAH. Recently, a retrospective single centre study has shown that riociguat treatment was associated with a significant reduction of RV and RA area after 3, 6 and 12 months compared to baseline. RA area significantly decreased after 12 months and RV systolic function assessed with tricuspid annular plane systolic excursion (TAPSE) improved after 6 and 12 months of riociguat therapy. The results were confirmed by a recent retrospective multicentre study. It is therefore reasonable to assume a beneficial effect of riociguat on right heart size and function.
The primary efficacy endpoint in this study is the change in RV and RA area from baseline to 24 weeks. Treatment will be initiated and individually adjusted according to systolic blood pressure and tolerability. Patients who discontinue medication prematurely will be asked to continue with study assessments and perform study visits as outlined in the protocol.
Medical examinations comprise medical history, physical examination, electrocardiogram (ECG), blood gas analyses, lung function tests, laboratory testing (including NT-proBNP), echocardiography at rest, and right heart catheterization (RHC) according to clinical practice of the PH centre.
The prospective period of data collection comprises a 24-week study period a follow-up phase of about 30±7 days.
Outcome (survival and transplant-free survival) of all patients will be assessed when the last patient has terminated his/her 24-week observation period.
Study Type
Enrollment (Estimated)
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: Ekkehard HD Grünig, MD
- Phone Number: 8053 +49 6221 396
- Email: ekkehard.gruenig@med.uni-heidelberg.de
Study Contact Backup
- Name: Benjamin P Egenlauf, MD
- Phone Number: 8078 +49 6221 396
- Email: benjamin.egenlauf@med.uni-heidelberg.de
Study Locations
-
-
-
Heidelberg, Germany, 69126
- Recruiting
- Centre for Pulmonary Hypertension at the Thoraxklinik Heidelberg, Heidelberg University Hospital
-
Principal Investigator:
- Ekkehard Grünig, MD
-
Contact:
- Ekkehard Grünig, MD
- Phone Number: 8053 +496221396
- Email: ekkehard.gruenig@med.uni-heidelberg.de
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- ≥18 years of age at time of inclusion.
- Male and female patients with symptomatic PAH with a mean pulmonary artery pressure (mPAP) >20 mmHg and pulmonary vascular resistance (PVR) ≥2 Wood Units (WU), pulmonary arterial wedge pressure (PAWP) ≤15 mmHg (Group I / Nice Clinical Classification of Pulmonary Hypertension) or CTEPH (Group IV / Nice Clinical Classification of Pulmonary Hypertension) defined as inoperable measured at least 3 months after start of full anticoagulation and mPAP >20 mmHg and PVR ≥2 WU, PAWP ≤15 mmHg; or with persisting or recurrent PH after pulmonary endarterectomy (mPAP >20 mmHg and PVR ≥2 WU, PAWP ≤15 mmHg measured at least 6 months after surgery (acc. to Simonneau et al. 2018).
- Treatment naïve patients (with respect to PAH specific medication) and patients pre-treated with an endothelin receptor antagonist or a prostacyclin analogue, pre-treated for 2 months before screening at most (according to upfront combination treatment).*
- *Pre-treated patients need to be stable on endothelin receptor antagonists or prostacyclin treatment for at least two weeks prior to Visit 1. "Stable" is defined as no change in the type of endothelin receptor antagonists or prostacyclin analogue and the respective daily dose.
- A patient may also be enrolled, if a persisting phosphodiesterase type 5 (PDE-5) inhibitor treatment (pre-treated for 2 months before screening at most) with or without combination treatment with an endothelin receptor antagonist or prostacyclin analogue is to be switched to riociguat by clinical indication, particularly when the patient´s risk-profile remained in intermediate risk group despite adequate initial treatment including PDE5i (defined as at least 3 of the following parameters: clinical signs of progression, persistent WHO-FC III, 6MWD between 165-440m, peak V02 11-15ml/min/kg (35-65% predicted), NTproBNP 300-1400 ng/l, RA-area 18-26cm2,RAP 8-14mmHg, CI 2,0-2,4 l/min) or in case of PDE5i intolerance. Any decision to switch will be made by the clinicians at a regular clinical follow-up visit.
- Unspecific treatments which may also be used for the treatment of PH such as oral anticoagulants, diuretics, digitalis, calcium channel blockers or oxygen supplementation are permitted. However, treatment with anticoagulants (if indicated) must have been started at least 1 month before visit in patients with PAH 1.
- RHC results must not be older than 6 months at screening (will be considered as baseline values) and must have been measured in the participating centre under standardized conditions (refer to the study specific Swan Ganz catheterization manual). If the respective measurements have not been performed in context with the patient's regular diagnostic workup, they have to be performed as a part of the study during the pre-study phase (after the patient signed the informed consent).
- Women without childbearing potential defined as postmenopausal women aged 50 years or older, women with bilateral tubal ligation, women with bilateral ovariectomy, and women with hysterectomy can be included in the study.
- Women of childbearing potential can only be included in the study if all of the following applies (listed below): a. Negative serum pregnancy test at Screening and a negative urine pregnancy test at study start (visit 1). b. Agreement to undertake monthly urine pregnancy tests during the study and up to at least 30 days after study treatment discontinuation. These tests should be performed by the patient at home. c. Agreement to follow the contraception scheme as specified from Screening until at least 30 days after study treatment discontinuation.
- Patients who are able to understand and follow instructions and who are able to participate in the study for the entire period.
- Patients must have given their written informed consent to participate in the study after having received adequate previous information and prior to any study-specific procedures.
Exclusion Criteria:
- Pregnant women, or breast-feeding women, or women of childbearing potential not able or willing to comply with study-mandated contraception methods specified above.
- Patients with PH specific treatment <2 months before screening.
- 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.
- Patients with underlying medical disorders with an anticipated life expectancy below 2 years (e.g. active cancer disease with localized and/or metastasized tumour mass).
- Patients with a history of severe or multiple drug allergies
- Patients with hypersensitivity to the investigational drug or any of the excipients.
- Patients unable to perform a valid 6MWD test (e.g. orthopaedic disease, peripheral artery occlusive disease, which affects the patient´s ability to walk).
The following specific medications for concomitant treatment of PH or medications which may exert a pharmacodynamic interaction with the study drug are not allowed:
- Parenteral prostacyclin analogues
- Specific phosphodiesterase inhibitors (e.g. sildenafil or tadalafil): may be switched to riociguat but not be given in addition to the study drug
- or unspecific phosphodiesterase inhibitors (e.g. dipyridamole, theophylline)
- NO donors (e.g. Nitrates)
Pulmonary diseases exclusions
- Moderate to severe bronchial asthma or COPD (Forced Expiratory Volume <60% predicted) or severe restrictive lung disease (Total Lung Capacity < 70% predicted) and/or defined as if high resolution computed tomography shows <20% parenchymal lung disease.
- Severe congenital abnormalities of the lungs, thorax, and diaphragm.
- Clinical or radiological evidence of Pulmonary-Veno-Occlusive Disease (PVOD) or Pulmonary Capillary Haemangiomatosis (PCH) or PH and idiopathic interstitial pneumonia (PH-IIP)
Cardiovascular exclusions:
- Uncontrolled arterial hypertension (systolic blood pressure >180 mmHg and /or diastolic blood pressure >110 mmHg).
- Systolic blood pressure <95 mmHg.
- Left heart failure with an ejection fraction less than 40%.
- Pulmonary venous hypertension with pulmonary arterial wedge pressure >15 mmHg.
- Hypertrophic obstructive cardiomyopathy.
- Severe proven or suspected coronary artery disease according to investigators opinion (patients with Canadian Cardiovascular Society Angina Classification class 2-4, and/or requiring nitrates, and/or myocardial infarction within the last 3 months before Visit 1).
- Clinical evidence of symptomatic atherosclerotic disease (e.g. peripheral artery disease with reduced walking distance, history of stroke with persistent neurological deficit etc).
Exclusions related to disorders in organ function:
a) Clinically relevant hepatic dysfunction indicated by: i. bilirubin >2 times upper limit normal ii. and / or hepatic transaminases >3 times upper limit normal iii. and / or signs of severe hepatic insufficiency (e.g. impaired albumin synthesis with an albumin < 32 g/l, hepatic encephalopathy > grade 1a: West Haven Criteria of Altered Mental Status In Hepatic Encephalopathy) b) Renal insufficiency (glomerular filtration rate <30 ml/min e.g. calculated based on the Cockcroft formula).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Riociguat
Riociguat (1 mg, 1.5 mg, 2 mg and 2.5 mg three times daily) starting at 1.0 mg three times daily at the beginning of the study.
Dosage will be individually up-titrated up to a maximum dosage of 2.5 mg three times daily after 8 weeks.
Study medication will be provided orally with or without food.
Tablets should be taken three times daily approximately 6 to 8 hours apart.
|
Treatment will be initiated and individually adjusted according to systolic blood pressure and tolerability.
During the titration phase, each patient will be asked to measure their peripheral systolic blood pressure and the heart rate at home three times per day and document the values in the patient diary.
The results will be examined by the investigator during each visit/phone call-visit.
Provided that the systolic blood pressure is ≥ 95 mmHg measured at trough before intake of each dose and the patient has no signs or symptoms of hypotension, the dose of study medication will be titrated by +0.5 mg tid every 2 weeks until maximal tolerated dosage (maximal permitted dose: of 2.5 mg tid).
After the titration period, blood pressure should be measured upon signs or symptoms of hypotension.
Maintenance dose: The established individual dose should be maintained unless signs and symptoms of hypotension occur.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in RV (right ventricular) area
Time Frame: Baseline to 24 weeks
|
echocardiographic analysis right atrial (RA) area, measured by echocardiography.
|
Baseline to 24 weeks
|
Change in RA (right atrial) area
Time Frame: Baseline to 24 weeks
|
echocardiographic analysis
|
Baseline to 24 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in RV Area
Time Frame: baseline to 12 weeks
|
echocardiographic analysis
|
baseline to 12 weeks
|
Change in RA Area
Time Frame: baseline to 12 weeks
|
echocardiographic analysis
|
baseline to 12 weeks
|
Change in systolic pulmonary artery pressure (sPAP)
Time Frame: baseline to 12 weeks
|
echocardiographic analysis
|
baseline to 12 weeks
|
Change in systolic pulmonary artery pressure (sPAP)
Time Frame: baseline to 24 weeks
|
echocardiographic analysis
|
baseline to 24 weeks
|
Change in RV fractional area change (FAC)
Time Frame: baseline to 24 weeks
|
echocardiographic analysis
|
baseline to 24 weeks
|
Change in RV fractional area change (FAC)
Time Frame: baseline to 12 weeks
|
echocardiographic analysis
|
baseline to 12 weeks
|
Change in Peak velocity of tricuspid regurgitation (TRV)
Time Frame: baseline to 12 weeks
|
echocardiographic analysis
|
baseline to 12 weeks
|
Change in Peak velocity of tricuspid regurgitation (TRV)
Time Frame: baseline to 24 weeks
|
echocardiographic analysis
|
baseline to 24 weeks
|
Change in inferior vena cava (IVC) diameter and IVC collapse
Time Frame: baseline to 24 weeks
|
echocardiographic analysis
|
baseline to 24 weeks
|
Change in inferior vena cava (IVC) diameter and IVC collapse
Time Frame: baseline to 12 weeks
|
echocardiographic analysis
|
baseline to 12 weeks
|
Change in Right Ventricle Outflow Tract Velocity Time Integral (RVOT VTI)
Time Frame: baseline to 12 weeks
|
echocardiographic analysis
|
baseline to 12 weeks
|
Change in Right Ventricle Outflow Tract Velocity Time Integral (RVOT VTI)
Time Frame: baseline to 24 weeks
|
echocardiographic analysis
|
baseline to 24 weeks
|
Change in Eccentricity index (EI)
Time Frame: baseline to 24 weeks
|
echocardiographic analysis
|
baseline to 24 weeks
|
Change in Eccentricity index (EI)
Time Frame: baseline to 12 weeks
|
echocardiographic analysis
|
baseline to 12 weeks
|
Change in Tricuspid Annular Plane Systolic Excursion (TAPSE)
Time Frame: baseline to 12 weeks
|
echocardiographic analysis
|
baseline to 12 weeks
|
Change in Tricuspid Annular Plane Systolic Excursion (TAPSE)
Time Frame: baseline to 24 weeks
|
echocardiographic analysis
|
baseline to 24 weeks
|
Change in Right ventricular pump function (qualitative)
Time Frame: baseline to 24 weeks
|
echocardiographic analysis
|
baseline to 24 weeks
|
Change in left ventricular pump function (qualitative)
Time Frame: baseline to 24 weeks
|
echocardiographic analysis
|
baseline to 24 weeks
|
Change in Right ventricular pump function (qualitative)
Time Frame: baseline to 12 weeks
|
echocardiographic analysis
|
baseline to 12 weeks
|
Change in left ventricular pump function (qualitative)
Time Frame: baseline to 12 weeks
|
echocardiographic analysis
|
baseline to 12 weeks
|
Change in Left Atrial (LA) diameter
Time Frame: baseline to 12 weeks
|
echocardiographic analysis
|
baseline to 12 weeks
|
Change in Left Atrial (LA) diameter
Time Frame: baseline to 24 weeks
|
echocardiographic analysis
|
baseline to 24 weeks
|
Change in LV diastolic function
Time Frame: baseline to 24 weeks
|
echocardiographic Analysis measured as: (LV transmitral E wave and A wave, E' wave of interventricular septum and lateral wall pulsed tissue Doppler, isovolumic relaxation time, mitral deceleration time)
|
baseline to 24 weeks
|
Change in LV diastolic function
Time Frame: baseline to 12 weeks
|
echocardiographic Analysis measured as: (LV transmitral E wave and A wave, E' wave of interventricular septum and lateral wall pulsed tissue Doppler, isovolumic relaxation time, mitral deceleration time)
|
baseline to 12 weeks
|
Change in Diameters of pulmonary artery
Time Frame: baseline to 12 weeks
|
echocardiographic Analysis
|
baseline to 12 weeks
|
Change in Diameters of pulmonary artery
Time Frame: baseline to 24 weeks
|
echocardiographic Analysis
|
baseline to 24 weeks
|
Change in cardiac index
Time Frame: baseline and after 24 weeks
|
Pulmonary hemodynamics by right heart catheterization
|
baseline and after 24 weeks
|
Change in cardiac output
Time Frame: baseline and after 24 weeks
|
Pulmonary hemodynamics by right heart catheterization
|
baseline and after 24 weeks
|
Change in sPAP
Time Frame: baseline and after 24 weeks
|
Pulmonary hemodynamics by right heart catheterization
|
baseline and after 24 weeks
|
Change in dPAP
Time Frame: baseline and after 24 weeks
|
Pulmonary hemodynamics by right heart catheterization
|
baseline and after 24 weeks
|
Change in mPAP
Time Frame: baseline and after 24 weeks
|
Pulmonary hemodynamics by right heart catheterization
|
baseline and after 24 weeks
|
Change in PAWP
Time Frame: baseline and after 24 weeks
|
Pulmonary hemodynamics by right heart catheterization
|
baseline and after 24 weeks
|
Change in right atrial pressure (RAP)
Time Frame: baseline and after 24 weeks
|
Pulmonary hemodynamics by right heart catheterization
|
baseline and after 24 weeks
|
Change in PVR
Time Frame: baseline and after 24 weeks
|
Pulmonary hemodynamics by right heart catheterization
|
baseline and after 24 weeks
|
Change in Central venous saturation from pulmonary artery
Time Frame: baseline and after 24 weeks
|
Pulmonary hemodynamics by right heart catheterization
|
baseline and after 24 weeks
|
Change in 6-minute walking distance
Time Frame: baseline to 12 weeks
|
Change in exercise capacity
|
baseline to 12 weeks
|
Change in 6-minute walking distance
Time Frame: baseline to 24 weeks
|
Change in exercise capacity
|
baseline to 24 weeks
|
forced vital capacity (FVC)
Time Frame: baseline to 12 weeks
|
Change in Lung function Tests
|
baseline to 12 weeks
|
forced vital capacity (FVC)
Time Frame: baseline to 24 weeks
|
Change in Lung function Tests
|
baseline to 24 weeks
|
Change in forced expiratory volume in one second (FEV1)
Time Frame: baseline to 12 weeks
|
Change in Lung function Tests
|
baseline to 12 weeks
|
Change in forced expiratory volume in one second (FEV1)
Time Frame: baseline to 24 weeks
|
Change in Lung function Tests
|
baseline to 24 weeks
|
Change in FEV1% of maximal vital capacity (VC max)
Time Frame: baseline to 12 weeks
|
Change in Lung function Tests
|
baseline to 12 weeks
|
Change in FEV1% of maximal vital capacity (VC max)
Time Frame: baseline to 24 weeks
|
Change in Lung function Tests
|
baseline to 24 weeks
|
Change in total lung capacity (TLC)
Time Frame: baseline to 12 weeks
|
Change in Lung function Tests
|
baseline to 12 weeks
|
Change in total lung capacity (TLC)
Time Frame: baseline to 24 weeks
|
Change in Lung function Tests
|
baseline to 24 weeks
|
Change in residual volume
Time Frame: baseline to 12 weeks
|
Change in Lung function Tests
|
baseline to 12 weeks
|
Change in residual volume
Time Frame: baseline to 24 weeks
|
Change in Lung function Tests
|
baseline to 24 weeks
|
Change in diffusion-limited carbon monoxide (DLCO)
Time Frame: baseline to 24 weeks
|
Change in Lung function Tests
|
baseline to 24 weeks
|
Change in diffusion-limited carbon monoxide (DLCO)
Time Frame: baseline to 12 weeks
|
Change in Lung function Tests
|
baseline to 12 weeks
|
Change in DLCO/VA (Krogh) factor
Time Frame: baseline to 12 weeks
|
Change in Lung function Tests
|
baseline to 12 weeks
|
Change in DLCO/VA (Krogh) factor
Time Frame: baseline to 24 weeks
|
Change in Lung function Tests
|
baseline to 24 weeks
|
Change in partial pressure of oxygen
Time Frame: baseline to 12 weeks
|
Change in capillary or arterial blood gas analysis
|
baseline to 12 weeks
|
Change in partial pressure of oxygen
Time Frame: baseline to 24 weeks
|
Change in capillary or arterial blood gas analysis
|
baseline to 24 weeks
|
Change in partial pressure of carbon dioxide
Time Frame: baseline to 12 weeks
|
Change in capillary or arterial blood gas analysis
|
baseline to 12 weeks
|
Change in partial pressure of carbon dioxide
Time Frame: baseline to 24 weeks
|
Change in capillary or arterial blood gas analysis
|
baseline to 24 weeks
|
Change in SaO2
Time Frame: baseline to 12 weeks
|
Change in capillary or arterial blood gas analysis
|
baseline to 12 weeks
|
Change in SaO2
Time Frame: baseline to 24 weeks
|
Change in capillary or arterial blood gas analysis
|
baseline to 24 weeks
|
Change in pH
Time Frame: baseline to 24 weeks
|
Change in capillary or arterial blood gas analysis
|
baseline to 24 weeks
|
Change in pH
Time Frame: baseline to 12 weeks
|
Change in capillary or arterial blood gas analysis
|
baseline to 12 weeks
|
Change in Blood pressure
Time Frame: baseline to 12 weeks
|
Change in Cardiopulmonary exercise testing
|
baseline to 12 weeks
|
Change in Blood pressure
Time Frame: baseline to 24 weeks
|
Change in Cardiopulmonary exercise testing
|
baseline to 24 weeks
|
Change in heart rate
Time Frame: baseline to 12 weeks
|
Change in Cardiopulmonary exercise testing
|
baseline to 12 weeks
|
Change in heart rate
Time Frame: baseline to 24 weeks
|
Change in Cardiopulmonary exercise testing
|
baseline to 24 weeks
|
Change in workload
Time Frame: baseline to 12 weeks
|
Change in Cardiopulmonary exercise testing
|
baseline to 12 weeks
|
Change in workload
Time Frame: baseline to 24 weeks
|
Change in Cardiopulmonary exercise testing
|
baseline to 24 weeks
|
Change in oxygen consumption as total and per kg body weight
Time Frame: baseline to 12 weeks
|
Change in Cardiopulmonary exercise testing
|
baseline to 12 weeks
|
Change in oxygen consumption as total and per kg body weight
Time Frame: baseline to 24 weeks
|
Change in Cardiopulmonary exercise testing
|
baseline to 24 weeks
|
Change in exhaled carbon dioxide (VCO2)
Time Frame: baseline to 12 weeks
|
Change in Cardiopulmonary exercise testing
|
baseline to 12 weeks
|
Change in exhaled carbon dioxide (VCO2)
Time Frame: baseline to 24 weeks
|
Change in Cardiopulmonary exercise testing
|
baseline to 24 weeks
|
Change in oxygen saturation
Time Frame: baseline to 12 weeks
|
Change in Cardiopulmonary exercise testing
|
baseline to 12 weeks
|
Change in oxygen saturation
Time Frame: baseline to 24 weeks
|
Change in Cardiopulmonary exercise testing
|
baseline to 24 weeks
|
Change in oxygen pulse
Time Frame: baseline to 12 weeks
|
Change in Cardiopulmonary exercise testing
|
baseline to 12 weeks
|
Change in oxygen pulse
Time Frame: baseline to 24 weeks
|
Change in Cardiopulmonary exercise testing
|
baseline to 24 weeks
|
Change in minute ventilation
Time Frame: baseline to 12 weeks
|
Change in Cardiopulmonary exercise testing
|
baseline to 12 weeks
|
Change in minute ventilation
Time Frame: baseline to 24 weeks
|
Change in Cardiopulmonary exercise testing
|
baseline to 24 weeks
|
Change in respiratory equivalents for oxygen
Time Frame: baseline to 12 weeks
|
Change in Cardiopulmonary exercise testing
|
baseline to 12 weeks
|
Change in respiratory equivalents for oxygen
Time Frame: baseline to 24 weeks
|
Change in Cardiopulmonary exercise testing
|
baseline to 24 weeks
|
Change in respiratory equivalents for carbon dioxide
Time Frame: baseline to 12 weeks
|
Change in Cardiopulmonary exercise testing
|
baseline to 12 weeks
|
Change in respiratory equivalents for carbon dioxide
Time Frame: baseline to 24 weeks
|
Change in Cardiopulmonary exercise testing
|
baseline to 24 weeks
|
Change in respiratory reserve
Time Frame: baseline to 12 weeks
|
Change in Cardiopulmonary exercise testing
|
baseline to 12 weeks
|
Change in respiratory reserve
Time Frame: baseline to 24 weeks
|
Change in Cardiopulmonary exercise testing
|
baseline to 24 weeks
|
WHO FC
Time Frame: baseline to 12 weeks
|
Change in WHO functional class
|
baseline to 12 weeks
|
WHO FC
Time Frame: baseline to 24 weeks
|
Change in WHO functional class
|
baseline to 24 weeks
|
SF-36
Time Frame: baseline to 24 weeks
|
Change in Quality of life parameters by questionnaire SF-36
|
baseline to 24 weeks
|
NT-proBNP
Time Frame: baseline to 12 weeks
|
Change in laboratory parameters
|
baseline to 12 weeks
|
NT-proBNP
Time Frame: baseline to 24 weeks
|
Change in laboratory parameters
|
baseline to 24 weeks
|
haemoglobin changes
Time Frame: baseline to 12 weeks
|
Change in laboratory parameters
|
baseline to 12 weeks
|
haemoglobin changes
Time Frame: baseline to 24 weeks
|
Change in laboratory parameters
|
baseline to 24 weeks
|
haematocrit changes
Time Frame: baseline to 12 weeks
|
Change in laboratory parameters
|
baseline to 12 weeks
|
haematocrit changes
Time Frame: baseline to 24 weeks
|
Change in laboratory parameters
|
baseline to 24 weeks
|
AST changes
Time Frame: baseline to 12 weeks
|
Change in liver enzymes
|
baseline to 12 weeks
|
AST changes
Time Frame: baseline to 24 weeks
|
Change in liver enzymes
|
baseline to 24 weeks
|
ALT changes
Time Frame: baseline to 12 weeks
|
Change in liver enzymes
|
baseline to 12 weeks
|
ALT changes
Time Frame: baseline to 24 weeks
|
Change in liver enzymes
|
baseline to 24 weeks
|
Bilirubin changes
Time Frame: baseline to 12 weeks
|
Change in liver enzymes
|
baseline to 12 weeks
|
Bilirubin changes
Time Frame: baseline to 24 weeks
|
Change in liver enzymes
|
baseline to 24 weeks
|
CRP changes
Time Frame: baseline to 12 weeks
|
Change in laboratory parameters
|
baseline to 12 weeks
|
CRP changes
Time Frame: baseline to 24 weeks
|
Change in laboratory parameters
|
baseline to 24 weeks
|
sodium changes
Time Frame: baseline to 12 weeks
|
Change in laboratory parameters
|
baseline to 12 weeks
|
sodium changes
Time Frame: baseline to 24 weeks
|
Change in laboratory parameters
|
baseline to 24 weeks
|
Urea changes
Time Frame: baseline to 12 weeks
|
Change in renal parameters
|
baseline to 12 weeks
|
Urea changes
Time Frame: baseline to 24 weeks
|
Change in renal parameters
|
baseline to 24 weeks
|
creatinine changes
Time Frame: baseline to 12 weeks
|
Change in renal parameters
|
baseline to 12 weeks
|
creatinine clearance changes
Time Frame: baseline to 12 weeks
|
Change in renal parameters
|
baseline to 12 weeks
|
creatinine changes
Time Frame: baseline to 24 weeks
|
Change in renal parameters
|
baseline to 24 weeks
|
creatinine clearance changes
Time Frame: baseline to 24 weeks
|
Change in renal parameters
|
baseline to 24 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Ekkehard HD Grünig, MD, Thoraxklinik at the University of Heidelberg
Publications and helpful links
General Publications
- Raymond RJ, Hinderliter AL, Willis PW, Ralph D, Caldwell EJ, Williams W, Ettinger NA, Hill NS, Summer WR, de Boisblanc B, Schwartz T, Koch G, Clayton LM, Jobsis MM, Crow JW, Long W. Echocardiographic predictors of adverse outcomes in primary pulmonary hypertension. J Am Coll Cardiol. 2002 Apr 3;39(7):1214-9. doi: 10.1016/s0735-1097(02)01744-8.
- Bossone E, D'Andrea A, D'Alto M, Citro R, Argiento P, Ferrara F, Cittadini A, Rubenfire M, Naeije R. Echocardiography in pulmonary arterial hypertension: from diagnosis to prognosis. J Am Soc Echocardiogr. 2013 Jan;26(1):1-14. doi: 10.1016/j.echo.2012.10.009. Epub 2012 Nov 8.
- Austin C, Alassas K, Burger C, Safford R, Pagan R, Duello K, Kumar P, Zeiger T, Shapiro B. Echocardiographic assessment of estimated right atrial pressure and size predicts mortality in pulmonary arterial hypertension. Chest. 2015 Jan;147(1):198-208. doi: 10.1378/chest.13-3035.
- Marra AM, Egenlauf B, Ehlken N, Fischer C, Eichstaedt C, Nagel C, Bossone E, Cittadini A, Halank M, Gall H, Olsson KM, Lange TJ, Grunig E. Change of right heart size and function by long-term therapy with riociguat in patients with pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension. Int J Cardiol. 2015 Sep 15;195:19-26. doi: 10.1016/j.ijcard.2015.05.105. Epub 2015 May 19.
- Marra AM, Halank M, Benjamin N, Bossone E, Cittadini A, Eichstaedt CA, Egenlauf B, Harutyunova S, Fischer C, Gall H, Ghofrani HA, Hoeper MM, Lange TJ, Olsson KM, Klose H, Grunig E. Right ventricular size and function under riociguat in pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension (the RIVER study). Respir Res. 2018 Dec 19;19(1):258. doi: 10.1186/s12931-018-0957-y.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2020-06RCT
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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Clinical Trials on Chronic Thromboembolic Pulmonary Hypertension
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University of California, San FranciscoRecruitingChronic Thromboembolic Pulmonary Hypertension | Chronic Thromboembolic DiseaseUnited States
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SciPharm SàRLCompletedNon-operable Chronic Thromboembolic Pulmonary HypertensionAustria, Poland, Czechia, Germany
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University of ZurichCompletedPulmonary Arterial and Chronic Thromboembolic Pulmonary Hypertension | Chronic Cardiorespiratory DiseaseSwitzerland
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ActelionEPS Corporation; Imepro Inc.; General Laboratory, BML, Inc.; Mitsubishi Logistics...TerminatedChronic Thromboembolic Pulmonary Hypertension (CTEPH)Japan
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University of California, San DiegoE Squared Trials and Registries, Inc.CompletedPulmonary Hypertension | Chronic Thromboembolic Pulmonary Hypertension (CTEPH)United States
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Assistance Publique - Hôpitaux de ParisMerck Sharp & Dohme LLCRecruitingPulmonary Embolism | Chronic Thromboembolic Pulmonary Hypertension (CTEPH)France
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University of ZurichCompletedPulmonary Arterial and Chronic Thromboembolic Pulmonary HypertensionSwitzerland
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University of SheffieldSheffield Teaching Hospitals NHS Foundation TrustUnknownChronic Thromboembolic Pulmonary Hypertension
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University of AarhusHospitalsenheden VestUnknownChronic Thromboembolic Pulmonary Disease
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China-Japan Friendship HospitalRecruitingChronic Thromboembolic Pulmonary HypertensionChina
Clinical Trials on Riociguat
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BayerCompletedPulmonary Disease, Chronic Obstructive | Hypertension, PulmonaryGermany
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BayerCompleted
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BayerCompletedHypertension, PulmonaryBelgium, United States, Switzerland, Canada, France, Germany, Italy, United Kingdom, Czechia
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BayerCompletedHypertension, PulmonaryJapan, Germany, Sweden, Colombia, Turkey, Belgium, Canada
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BayerRecruitingHypertension, PulmonaryFrance, Italy, Korea, Republic of, Poland, Thailand
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BayerActive, not recruiting
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BayerCompletedPulmonary HypertensionBelgium, France, Spain, Turkey, Portugal, Taiwan, Japan, United States, Switzerland, Korea, Republic of, Austria, Canada, China, Denmark, Germany, Mexico, Russian Federation, Argentina, Italy, Poland, Australia, Brazil, Czechia, United... and more
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BayerCompletedHypertension, PulmonaryBelgium, France, China, Turkey, Portugal, Taiwan, Japan, Singapore, United States, Argentina, Switzerland, Mexico, Austria, Thailand, Canada, Denmark, Germany, Russian Federation, Australia, Italy, Korea, Republic of, Sweden, Poland, United... and more
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BayerCompletedHypertension, PulmonaryTurkey, Austria, Czechia, Russian Federation, Slovakia, Switzerland, Italy, Germany, United Kingdom, France, Belgium, Canada, Colombia, Greece, Luxembourg, Netherlands, Spain, Taiwan, Denmark, Sweden, Argentina, Portugal, Saudi Arabia, Austral... and more