Evidence map›Paper›PMID 42538528›Full record

Trial reportRespiratory research2026

Effects of riociguat on right ventricular size and function in pulmonary arterial hypertension (RIVER II): a prospective, phase IV study.

Satenik Harutyunova, Jonathan Heinz, Nicola Benjamin, Lena Brückner, Faruk Sehic, Benjamin Egenlauf, Antonio Cittadini, Alberto M Marra, Ekkehard Grünig, Panagiota Xanthouli

Registry-linked trialAbstract readClinical Trial, Phase IV
In one paragraph

Trial report in Respiratory research, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04954742 (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), which is not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04954742 phase4terminatednot on this map

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

TypeinterventionalSponsorHeidelberg UniversityRan2022 to 2025Enrolled30ConditionsPrimary Pulmonary Arterial Hypertension, Chronic Thromboembolic Pulmonary HypertensionArmsRiociguat
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors.

Satenik HarutyunovaCentre for Pulmonary Hypertension, Thoraxklinik-Heidelberg gGmbH at Heidelberg University Hospital and Translational Lung Research Centre Heidelberg (TLRC), Member of the German Centre for Lung Research (DZL), Roentgenstraße 1, Heidelberg, 69126, Germany.
Jonathan HeinzCentre for Pulmonary Hypertension, Thoraxklinik-Heidelberg gGmbH at Heidelberg University Hospital and Translational Lung Research Centre Heidelberg (TLRC), Member of the German Centre for Lung Research (DZL), Roentgenstraße 1, Heidelberg, 69126, Germany.
Nicola BenjaminCentre for Pulmonary Hypertension, Thoraxklinik-Heidelberg gGmbH at Heidelberg University Hospital and Translational Lung Research Centre Heidelberg (TLRC), Member of the German Centre for Lung Research (DZL), Roentgenstraße 1, Heidelberg, 69126, Germany.
Lena BrücknerCentre for Pulmonary Hypertension, Thoraxklinik-Heidelberg gGmbH at Heidelberg University Hospital and Translational Lung Research Centre Heidelberg (TLRC), Member of the German Centre for Lung Research (DZL), Roentgenstraße 1, Heidelberg, 69126, Germany.
Faruk SehicCentre for Pulmonary Hypertension, Thoraxklinik-Heidelberg gGmbH at Heidelberg University Hospital and Translational Lung Research Centre Heidelberg (TLRC), Member of the German Centre for Lung Research (DZL), Roentgenstraße 1, Heidelberg, 69126, Germany.
Benjamin EgenlaufCentre for Pulmonary Hypertension, Thoraxklinik-Heidelberg gGmbH at Heidelberg University Hospital and Translational Lung Research Centre Heidelberg (TLRC), Member of the German Centre for Lung Research (DZL), Roentgenstraße 1, Heidelberg, 69126, Germany.
Antonio CittadiniDepartment of Translational Medical Sciences, ''Federico II"University of Naples, ''Federico II" University Hospital and School of Medicine, Naples, Italy.
Alberto M MarraDepartment of Translational Medical Sciences, ''Federico II"University of Naples, ''Federico II" University Hospital and School of Medicine, Naples, Italy.
Ekkehard GrünigCentre for Pulmonary Hypertension, Thoraxklinik-Heidelberg gGmbH at Heidelberg University Hospital and Translational Lung Research Centre Heidelberg (TLRC), Member of the German Centre for Lung Research (DZL), Roentgenstraße 1, Heidelberg, 69126, Germany.
Panagiota XanthouliCentre for Pulmonary Hypertension, Thoraxklinik-Heidelberg gGmbH at Heidelberg University Hospital and Translational Lung Research Centre Heidelberg (TLRC), Member of the German Centre for Lung Research (DZL), Roentgenstraße 1, Heidelberg, 69126, Germany. panagiota.xanthouli@med.uni-heidelberg.de.ORCID http://orcid.org/0000-0002-7743-2472

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPulmonary arterial hypertension (PAH) is characterized by right ventricular (RV) pressure overload, dilatation and dysfunction, which are key prognostic determinants. While riociguat improves exercise capacity and hemodynamics, prospective data on reverse remodeling remain limited. This prospective, phase IV study evaluated the effects of riociguat on right-heart size, function, hemodynamics, exercise capacity and safety in PAH patients.

methodsTreatment-naïve or pretreated PAH patients were enrolled. Patients receiving phosphodiesterase-5 inhibitors (PDE5i) could be switched to riociguat upon clinical indication. The primary endpoint was the change in right atrial (RA) and RV area at 24 weeks. Secondary endpoints included additional echocardiographic, clinical, exercise, hemodynamic and laboratory parameters, as well as quality-of-life (QoL) and safety.

resultsThirty patients (61.2 ± 14.5 years; 76.7% male; 24 PDE5i-pretreated) were enrolled. Marked right-heart dilatation and impaired RV function were prominent at baseline. At week 24, riociguat significantly reduced RA (Δ -3.17 ± 5.91 cm²; p = 0.006) and RV area (Δ -6.00 ± 3.80 cm²; p < 0.0001). Furthermore, RV-fractional area change, 6-minute walking distance and functional class improved significantly. In patients with invasive follow-up, cardiac index increased significantly, with favorable trends in further parameters. N-terminal pro-brain natriuretic peptide and QoL remained unchanged. The study terminated early following the decision by the supplier Merck/MSD; the termination was not safety related. Riociguat was generally well tolerated with no new safety concerns.

conclusionRiociguat therapy resulted in a statistically significant improvement in right ventricular and atrial size and function with further improvements in exercise capacity and functional class. This prospective trial confirms the findings of previous retrospective studies and supports riociguat as an effective treatment option to improve RV geometry and performance.

trial registrationThis trial was registered on clinicaltrials.gov with the ClinicalTrials.gov ID NCT04954742.

Indexed as

Heart VentriclesHypertension, PulmonaryPulmonary Arterial HypertensionPyrazolesPyrimidinesVentricular Function, RightAgedFemaleHumansMaleMiddle AgedPhosphodiesterase 5 InhibitorsProspective StudiesTreatment OutcomePhosphodiesterase 5 InhibitorsPyrazolesPyrimidinesriociguatEchocardiographyPulmonary arterial hypertensionRight-heart size and functionRiociguat

Identifiers

PMID42538528
PMCPMC13425866

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.