Evidence map›Paper›PMID 24991733›Full record

Trial reportChest2014

Acute hemodynamic effects of riociguat in patients with pulmonary hypertension associated with diastolic heart failure (DILATE-1): a randomized, double-blind, placebo-controlled, single-dose study.

Diana Bonderman, Ingrid Pretsch, Regina Steringer-Mascherbauer, Pavel Jansa, Stephan Rosenkranz, Caroline Tufaro, Andja Bojic, Carolyn S P Lam, Reiner Frey, Michael Ochan Kilama and 3 more

Registry-linked trialOpen access · bronzeAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Chest, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01172756 (Acute Hemodynamic Effects of Riociguat), which is not on this map. Cited by 117 papers, 9 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
117citing papers in PubMed, 9 pooled it
25.4field-weighted citation impact, top 1% of its field
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.

NCT01172756 phase2terminatednot on this map

Acute Hemodynamic Effects of Riociguat (BAY63-2521) in Patients With Pulmonary Hypertension Associated With Diastolic Heart Failure: A Randomized, Double-blind, Placebo-controlled, Single-dose Study in Three Ascending Dose Cohorts

TypeinterventionalSponsorBayerRan2010 to 2012Enrolled39ConditionsHypertension, Pulmonary, Ventricular Dysfunction, LeftArmsRiociguat (BAY63-2521), Placebo
3 · Its place in the literature

Who cites it

117 citing papers in PubMed, 9 syntheses or guidelines pooled it, 252 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Pooled it
  6. Pooled it
  7. Pooled it
  8. Pooled it
  9. Guanylate cyclase stimulators for pulmonary hypertension.The Cochrane database of systematic reviews · 2016
    Pooled it
  10. Trial
  11. Trial
  12. Trial
  13. Trial
  14. Trial
  15. Trial
  16. Article
  17. Review
  18. Review
  19. Review
  20. Review

57 more citing papers are in PubMed but not listed here.

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

13 authors at 8 institutions in 5 countries.

Diana BondermanFrom the Department of Internal Medicine II, Medical University of Vienna, Vienna, Austria. Electronic address: diana.bonderman@meduniwien.ac.at.
Ingrid PretschDepartment of Internal Medicine II, Paracelsus Medical University Salzburg, Salzburg, Austria.
Regina Steringer-MascherbauerSecond Department of Medicine, Public Hospital Elisabethinen, Linz, Austria.
Pavel JansaClinical Department of Cardiology and Angiology of the First Faculty of Medicine and General Teaching Hospital, Prague, Czech Republic.
Stephan RosenkranzClinic III for Internal Medicine, Heart Center at the University Hospital of Cologne, Cologne, Germany.
Caroline TufaroFrom the Department of Internal Medicine II, Medical University of Vienna, Vienna, Austria.
Andja BojicFrom the Department of Internal Medicine II, Medical University of Vienna, Vienna, Austria.
Carolyn S P LamNational University Health System, Singapore.
Reiner FreyBayer HealthCare Pharmaceuticals, Wuppertal, Germany.
Michael Ochan KilamaBayer HealthCare Pharmaceuticals, Milan, Italy.
Sigrun UngerBayer HealthCare Pharmaceuticals, Wuppertal, Germany.
Lothar RoessigBayer HealthCare Pharmaceuticals, Wuppertal, Germany.
Irene M LangFrom the Department of Internal Medicine II, Medical University of Vienna, Vienna, Austria.
Medical University of Vienna · ATBayer (Germany) · DEBayer (Italy) · ITGeneral University Hospital in Prague · CZKrankenhaus der Elisabethinen · ATNational University Health System · SGParacelsus Medical University · ATUniversity Hospital Cologne · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundDeficient nitric oxide-soluble guanylate cyclase-cyclic guanosine monophosphate signaling results from endothelial dysfunction and may underlie impaired cardiac relaxation in patients with heart failure with preserved left ventricular ejection fraction (HFpEF) and pulmonary hypertension (PH). The acute hemodynamic effects of riociguat, a novel soluble guanylate cyclase stimulator, were characterized in patients with PH and HFpEF.

methodsClinically stable patients receiving standard HF therapy with a left ventricular ejection fraction > 50%, mean pulmonary artery pressure (mPAP) ≥ 25 mm Hg, and pulmonary arterial wedge pressure (PAWP) > 15 mm Hg at rest were randomized to single oral doses of placebo or riociguat (0.5, 1, or 2 mg). The primary efficacy variable was the peak decrease in mPAP from baseline up to 6 h. Secondary outcomes included hemodynamic and echocardiographic parameters, safety, and pharmacokinetics.

resultsThere was no significant change in peak decrease in mPAP with riociguat 2 mg (n = 10) vs placebo (n = 11, P = .6). However, riociguat 2 mg significantly increased stroke volume (+9 mL [95% CI, 0.4-17]; P = .04) and decreased systolic BP (-12 mm Hg [95% CI, -22 to -1]; P = .03) and right ventricular end-diastolic area (-5.6 cm2 [95% CI, -11 to -0.3]; P = .04), without significantly changing heart rate, PAWP, transpulmonary pressure gradient, or pulmonary vascular resistance. Riociguat was well tolerated.

conclusionsIn patients with HFpEF and PH, riociguat was well tolerated, had no significant effect on mPAP, and improved exploratory hemodynamic and echocardiographic parameters. TRIAL REGISTRY: ClinicalTrials.gov; No.: NCT01172756; URL: www.clinicaltrials.gov.

Indexed as

Administration, OralAgedAged, 80 and overDose-Response Relationship, DrugDouble-Blind MethodEchocardiographyFemaleFollow-Up StudiesHeart Failure, DiastolicHeart VentriclesHemodynamicsHumansHypertension, PulmonaryMaleMiddle AgedPyrazolesPyrazolesPyrimidinesriociguat

Identifiers

PMID24991733
PMCPMC4219342
OpenAlexW1984243104

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.