Evidence map›Paper›PMID 35867804›Full record

Trial reportEuropean journal of heart failure2022

Safety and efficacy of istaroxime in patients with acute heart failure-related pre-cardiogenic shock - a multicentre, randomized, double-blind, placebo-controlled, parallel group study (SEISMiC).

Marco Metra, Ovidiu Chioncel, Gad Cotter, Beth Davison, Gerasimos Filippatos, Alexandre Mebazaa, Maria Novosadova, Piotr Ponikowski, Phillip Simmons, Joseph Soffer and 1 more

Registry-linked trialOpen access · greenAbstract readRandomized Controlled TrialMulticenter Study
In one paragraph

Trial report in European journal of heart failure, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04325035 (A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study on the Safety and Efficacy of Istaroxime for Pre-Cardiogenic Shock), which is not on this map. Cited by 28 papers.

0numbers the graph read from it
0cells of the map it votes in
28citing papers in PubMed
3.0field-weighted citation impact, top 8% 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.

NCT04325035 phase2completednot on this map

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study on the Safety and Efficacy of Istaroxime for Pre-Cardiogenic Shock (SEISMiC)

TypeinterventionalSponsorWindtree TherapeuticsRan2020 to 2024Enrolled90ConditionsCardiogenic ShockArmsIstaroxime, Placebo
3 · Its place in the literature

Who cites it

28 citing papers in PubMed, 39 citations in OpenAlex.

  1. Trial
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  13. 2024 update in heart failure.ESC heart failure · 2025
    Review
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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

11 authors at 7 institutions in 7 countries.

Marco MetraCardiology Unit, ASST Spedali Civili, Department of Medical and Surgical Specialties, Radiological Sciences, and Public Health, University of Brescia, Brescia, Italy.
Ovidiu ChioncelEmergency Institute for Cardiovascular Diseases 'Prof. C.C. Iliescu', Bucharest, Romania.
Gad CotterMomentum Research, Inc, Chapel Hill, NC, USA.
Beth DavisonMomentum Research, Inc, Chapel Hill, NC, USA.
Gerasimos FilippatosDepartment of Cardiology, University of Cyprus, School of Medicine & National and Kapodistrian University of Athens, School of Medicine, Attikon University Hospital, Athens, Greece.
Alexandre MebazaaCardiovascular Markers in Stress Conditions (MASCOT), Université Paris Cité; Inserm UMR-S 942, Paris, France.
Maria NovosadovaMomentum Research, Inc, Chapel Hill, NC, USA.
Piotr PonikowskiDepartment of Heart Diseases, Wroclaw Medical University, Wrocław, Poland.
Phillip SimmonsWindtree Therapeutics, Inc., Warrington, PA, USA.
Joseph SofferWindtree Therapeutics, Inc., Warrington, PA, USA.
Steven SimonsonWindtree Therapeutics, Inc., Warrington, PA, USA.
Délégation Paris 5 · FRWindtree Therapeutics (United States) · USCarol Davila University of Medicine and Pharmacy · ROMomentum Research · USNational and Kapodistrian University of Athens · GRUniversity of Brescia · ITWroclaw Medical University · PL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsWe examined the effects of istaroxime in patients hospitalized for acute heart failure (AHF) related Society for Cardiovascular Angiography and Interventions (SCAI) stage B pre-cardiogenic shock (CS). METHODS AND

resultsSixty patients with AHF without acute myocardial infarction with pre-CS, defined as systolic blood pressure (SBP) <90 mmHg without hypoperfusion, venous lactate ≥2 mmol/L and/or mechanical or inotropic support, were randomized to istaroxime 1.0-1.5 μg/kg/min or placebo for 24 h. The primary endpoint, the adjusted area under the curve (AUC) change in SBP from time of treatment to 6 h, was 53.1 (standard error [SE] 6.88) mmHg × hour versus 30.9 (SE 6.76) mmHg × hour with istaroxime versus placebo (p = 0.017). Adjusted SBP AUC at 24 h was 291.2 (SE 27.5) versus 208.7 (SE 27.0) mmHg × hour (p = 0.025). At 24 h, some echocardiographic measurements improved with istaroxime versus placebo including cardiac index (+0.21 L/min/m

conclusionIn a phase 2a study of patients with AHF related pre-CS, istaroxime improved blood pressure and some echocardiography measures related to heart failure and was well tolerated.

Indexed as

Heart FailureCardiotonic AgentsDouble-Blind MethodEtiocholanoloneHumansShock, CardiogenicCardiotonic AgentsEtiocholanoloneIstaroximeAcute heart failureBlood pressureCardiogenic shockIstaroximeSERCA2aTherapeutics

Identifiers

PMID35867804
PMCPMC9804717
OpenAlexW4286587244

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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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.