Cardiogenic ShockPhase 2SEISMiCNCT04325035

The Safety and Efficacy of Istaroxime for Pre-Cardiogenic Shock

A Phase 2 study testing Istaroxime in people with Cardiogenic Shock, run by Windtree Therapeutics at 13 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

This is a pilot, multinational, randomized, double-blind, placebo-controlled, 2-part safety and efficacy study. Subjects will consist of patients hospitalized for acute decompensated heart failure with persistent hypotension. Read more about this study

Who is it for?: Ages 18 to 85 years
Conditions the study is for: Cardiogenic Shock
What is being tested?: Istaroxime
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 90 participants
Where: 13 sitesin 4 countries
Study dates: 28 Sep 2020to 30 Oct 2024
Phase: Phase 2
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 85 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Clinical presentation consistent with SCAI Stage B pre-cardiogenic shock caused by acute decompensation of chronic systolic heart failure (due to arterial hypertension, ischemic heart disease or dilated cardiomyopathy), without evidence for an acute coronary syndrome.
Signed informed consent form (ICF);
Males and females, 18 to 85 years of age (inclusive);
An admission for acute decompensated heart failure (ADHF) episode within 36 hours prior to randomization, defined as:
Dyspnea, at rest or with minimal exertion;
Congestion on chest x-ray or lung US with B-type natriuretic peptide (BNP) ≥ 400 pg/mL or NT-proBNP ≥ 1400 pg/mL; Elective admissions for medications tune up or procedures do not qualify as an ADHF admission.

Show all 13Show fewer

History of left ventricular ejection fraction (LVEF) ≤ 40%;
Persistent hypotension defined as:
SBP of 75 to 90 mmHg (Part A) or 70 to 100 mmHg (Part B) for ≥ 2 hours prior to Screening;
SBP does not decrease by > 7 mmHg on two separate measurements during the last 2 hours prior to randomization;
Heart rate 75 to 150 bpm. If the subject is on a beta-blocker, the range is 60 to 150 bpm;
Echocardiogram during initial hospitalization confirming ejection fraction ≤ 40% and no evidence of other pathology to confound interpretation of cardiac physiology (e.g., pericardial effusion);
Subject is monitored by a Pulmonary Artery Catheter (PAC) at the time of randomization (Part B only).

Who cannot join

Cardiogenic shock of SCAI Stage C or worse
Cardiogenic shock due to any other condition besides acute decompensation of chronic heart failure.
Any of the following in the past 30 days: acute coronary syndrome, coronary revascularization, myocardial infarction (MI), coronary artery bypass graft (CABG), or percutaneous coronary intervention;
Current (within 6 hours of Screening) or anticipated need for treatment with positive inotropic agents or vasopressors, renal support including ultrafiltration, or mechanical circulatory, ventilatory or renal support (intra-aortic balloon pump, endotracheal intubation, mechanical ventilation, or any ventricular assist device);
Venous Lactate > 2 mmol/L;
History of heart transplant or United Network for Organ Sharing (UNOS) priority 1a heart transplant listing

Show all 32Show fewer

Ongoing treatment with digoxin (if digoxin was stopped before signing the ICF and the digoxin plasma level is < 0.5 ng/ml, the patient may be enrolled);
Severe renal impairment (estimated glomerular filtration rate (eGFR) < 30 ml/min, calculated by the Modification of Diet in Renal Disease (MDRD) formula);
Hypersensitivity to the study medication or any of its excipients (including known lactose hypersensitivity) or any related medication;
Stroke or transient ischemic attack (TIA) within 3 months;
Active coronary ischemia;
Any significant valvular disease (including any moderate or severe valvular stenosis, moderate or severe aortic or pulmonary regurgitation, stenosis or regurgitation);severe tricuspid or mitral regurgitation);
Primary hypertrophic or restrictive cardiomyopathy or systemic illness known to be associated with infiltrative heart disease;
Admission for AHF triggered primarily by a correctable etiology such as significant arrhythmia, (inclusive of atrial fibrillation as the main reason for admission), infection, severe anemia, acute coronary syndrome, pulmonary embolism, exacerbation of chronic obstructive pulmonary disease (COPD), planned admission for device implantation, or over-diuresis as a cause of hypotension;
Pericardial constriction or active pericarditis;
Life-threatening ventricular arrhythmia or implantable cardioverter defibrillator (ICD) shock within the past month or history of sudden death within 6 months;
Cardiac resynchronization therapy (CRT), ICD, or pacemaker implantation (or planned implantation) within the past 3 months;
Sustained ventricular tachycardia in the last 3 months with no defibrillator;
Sustained hypotension (SBP < 70 mmHg) for at least 30 minutes from the time of arrival to the hospital;
Severe pulmonary disease or cor pulmonale or other causes of isolated right-sided HF or not related to left ventricular dysfunction;
Acute respiratory distress syndrome;
Suspected sepsis; fever > 38°C or active infection requiring IV antimicrobial treatment;
Body weight < 40 kg or ≥ 150 kg;
Laboratory exclusions:
Hemoglobin < 9 g/dl,
Platelet count < 100,000/µl,
Serum potassium > 5.3 mmol/l or < 3.5 mmol/l;
A life expectancy < 3 months based on the judgment of the investigator;
Uncontrolled thyroid disease;
Pregnant or breast-feeding;
Ongoing drug or alcohol abuse;
Participation in another interventional study within the past 30 days.

Trial locations and contacts

13 sites in 4 countries.

Country

City, postcode or hospital

13 sites in 4 countries

Argentina5 sites

Santorio de la Trinidad Palermo
Buenos Aires, C1425
Hospital Italiano de Bueno Aires
Capital Federal, Buenos Aires, C1199
Santorio Guemes
Capital Federal, Buenos Aires, CP1180
Hospital Privado de Rosario
Rosario, Sante Fe, S20000GAP
Instituto Cardiovascular de Rosario
Rosario, Sante Fe, S2000DSR

Other trials in Argentina

Poland4 sites

Uniwersytecki Szpital Kliniczny w Białymstoku
Bialystok, 15-276
Uniwersytecki Szpital Kliniczny w Opolu
Opole, 45-401
Uniwersytecki Szpital Kliniczny, Centrum Chorub Serca
Wroclaw, Lower Silesian Voivodeship, 50-556
4 Wojskowy Szpital Kliniczny
Wroclaw, 50-981

Other trials in Poland

Italy3 sites

Azienda Ospedaliera Santi Antonio e Biagio e Cesare Arrigo
Alessandria
UOC Cardiologia, ASST degli Spedali Civili di Brescia Pizzale Spedali Civili 1
Brescia, 25123
IRCCS San Raffaele Scientific Institute
Milan, 20132

Other trials in Italy

United States1 site

Tufts Medical Center
Boston, Massachusetts, 02111

Other trials in United States

About this study

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

Read the detailed description

This is a pilot, multinational, multicenter, randomized, double-blind, placebo-controlled, 2-part safety and efficacy study. Subjects will consist of males or females 18 to 85 years of age, hospitalized for acute decompensated heart failure (ADHF) with persistent hypotension (systolic blood pressure [SBP] 70-100 mmHg for two hours).

Part A will dose all subjects for 24 hours with either 1.0 µg/kg/min or placebo; Part B will dose all subjects for 60 hours with two different regimens of istaroxime or placebo. Enrollment of Part A and Part B will be sequential.

Up to 30 sites in Part A; up to 15 sites in Part B. Sites may be located in Europe, Asia, South America, and North America.

Conditions: Cardiogenic Shock
Being tested: Istaroxime, Placebo
Keywords: Pre-cardiogenic shock, Heart failure
Medical subject headings: Shock, Cardiogenic, Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

IstaroximeDrug
Also called PST2744
Reconstituted istaroxime and lactose lyophilized powder delivered via IV infusion
PlaceboDrug
Also called Lactose lyophilized powder
Reconstituted placebo (lactose lyophilized powder) delivered via IV infusion

Study groups in NCT04325035
Study group	Role	What they receive
Istaroxime - Part A	Experimental	Istaroxime IV infusion for 24 hours. Istaroxime administration can begin at 1.0 or 1.5 µg/kg/min; the target infusion rate is 1.5 µg/kg/min Receives: Drug: Istaroxime
Placebo - Part A	Placebo comparator	Placebo (lactose lyophilized powder) IV infusion for 24 hours Receives: Drug: Placebo
Istaroxime - Part B	Experimental	Istaroxime IV infusion at 1.0 µg/kg/min for 6 hours, 0.5 µg/kg/min for 42 hours, 0.25 µg/kg/min for 12 hours. Receives: Drug: Istaroxime
Istaroxime and Placebo - Part B	Experimental	Istaroxime IV infusion at 0.5 µg/kg/min for 48 hours, followed by placebo IV infusion for 12 hours. Receives: Drug: Istaroxime; Drug: Placebo
Placebo - Part B	Placebo comparator	Placebo (lactose lyophilized powder) IV infusion for 60 hours. Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Change from baseline in systolic blood pressure (SBP) area under the curve (AUC) 0-6
Change from baseline AUC for systolic blood pressure
Measured: 0 to 6 hours after initiation of infusion

Secondary outcomes (29)

Change from baseline in SBP AUC 0-48
Change from baseline in AUC for systolic blood pressure in Part B
Measured: 0 to 60 hours after initiation of infusion
Change from baseline in SBP AUC 0-60
Change from baseline in AUC for systolic blood pressure in Part B
Measured: 0 to 48 hours after initiation of infusion
Treatment failure score
Treatment-failure score, based on death, circulatory, respiratory, or renal mechanical support or intravenous inotrope or vasopressor treatment, and changes in systolic blood pressure
Measured: 60 hours from initiation of infusion
Change from baseline in SBP
Change from baseline in systolic blood pressure
Measured: 6 hours after initiation of infusion
Change from baseline in SBP
Change from baseline in systolic blood pressure
Measured: 24 hours after initiation of infusion
Change from baseline in SBP
Change from baseline in systolic blood pressure in Part B
Measured: 48 hours after initiation of infusion
Change from baseline in SBP
Change from baseline in systolic blood pressure in Part B
Measured: 60 hours after initiation of infusion
Number of treatment failures
Number of subjects requiring treatment with intravenous vasopressors, inotropes, and/or mechanical cardiac or renal support or have died
Measured: Randomization to 24 hours for Part A
Number of treatment failures
Number of subjects requiring treatment with intravenous vasopressors, inotropes, and/or mechanical cardiac or renal support or have died
Measured: Randomization to 48 hours for Part B
Number of treatment failures
Number of subjects requiring treatment with intravenous vasopressors, inotropes, and/or mechanical cardiac or renal support or have died
Measured: Randomization to Day 5
Change in quality of life
Changes from baseline measured by the EQ-5D in Part A
Measured: Baseline to Day 5 (96 hours) from infusion start
Change in quality of life
Changes from baseline measured by the EQ-5D in Part A
Measured: Baseline to Day 30 from infusion start
Change in eGFR
Change from baseline and observed estimated glomerular filtration rate (eGFR)
Measured: 24 hours from infusion start
Change in eGFR
Change from baseline and observed estimated glomerular filtration rate (eGFR)
Measured: 48 hours from infusion start
Change in brain natriuretic peptide (BNP), N-terminal pro hormone B-type natriuretic peptide (NT-pro-BNP), troponin (cTn; either T or I) and venous lactate
Change from baseline and observed BNP, NT-pro-BNP, troponin (cTn; either T or I) and venous lactate
Measured: 24 hours from infusion start
Change in brain natriuretic peptide (BNP), N-terminal pro hormone B-type natriuretic peptide (NT-pro-BNP), troponin (cTn; either T or I) and venous lactate
Change from baseline and observed BNP, NT-pro-BNP, troponin (cTn; either T or I) and venous lactate
Measured: 48 hours from infusion start
Time to worsening heart failure (HF)
Time to worsening HF
Measured: Up to Day 5
Time to HF re-admission or death
Time to HF re-admission or death
Measured: Up to Day 30
Length of initial hospitalization
Length of initial hospitalization
Measured: Up to Day 30
Days alive and out of the hospital
Days alive and out of the hospital
Measured: Up to Day 30
Mortality and reasons for death
Mortality and reasons for death
Measured: Up to Day 30
Change in coronary index (CI)
Change from baseline in CI as assessed by echocardiogram - Part A
Measured: 24 hours
Change in E to e' ratio
Change from baseline in E to e' ratio as assessed by echocardiogram - Part A
Measured: 24 hours
Change in stroke volume index (SVI)
Change from baseline in SVI as assessed by echocardiogram - Part A
Measured: 24 hours
Change in left atrium area (LAA)
Change from baseline in LAA as assessed by echocardiogram - Part A
Measured: 24 hours
Change in CI
Change from baseline in CI as assessed by echocardiogram - Part B
Measured: 48 hours
Change in E to e' ratio
Change from baseline in E to e' ratio as assessed by echocardiogram - Part B
Measured: 48 hours
Change in SVI
Change from baseline in SVI as assessed by echocardiogram - Part B
Measured: 48 hours
Change in LAA
Change from baseline in LAA as assessed by echocardiogram - Part B
Measured: 48 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

28 Sep 202030 Oct 2024

First posted27 Mar 2020
Study start28 Sep 2020
Primary completion26 Sep 2024
Study completion30 Oct 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Cardiogenic ShockStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 90 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04325035
Sponsor's protocol ID: 04-CL-1904
Other IDs: 2020-000885-40
Acronym: SEISMiC
Status last verified: Jan 2025
First submitted: 24 Mar 2020
Last updated: 4 Feb 2025
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Metra M, Chioncel O, Cotter G, Davison B, Filippatos G, Mebazaa A, Novosadova M, Ponikowski P, Simmons P, Soffer J, Simonson S. 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). Eur J Heart Fail. 2022 Oct;24(10):1967-1977. doi: 10.1002/ejhf.2629. Epub 2022 Aug 22.
PubMed 35867804
Metra M, Chioncel O, Davison B, Filippatos G, Mebazaa A, Pagnesi M, Adamo M, Novosadova M, Ponikowski P, Simmons P, Soffer J, Simonson S, Cotter G. Safety and Efficacy of Istaroxime 1.0 and 1.5 microg/kg/min for Patients With Pre-Cardiogenic Shock. J Card Fail. 2023 Jul;29(7):1097-1103. doi: 10.1016/j.cardfail.2023.03.020. Epub 2023 Apr 17.
PubMed 37075941

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Evaluation of Acid-base Disorders and Ventilation Settings in Cardiogenic Shock and Post-cardiac Arrest Patients: Comparison With VentilO Algorithm
Cardiac Arrest (CA), Cardiogenic Shock
Not yet recruitingObservational study
Hemodynamic Evaluation of Left Atrial Pressure in Relationship to Pulmonary Capillary Wedge Pressure in Cardio Thoracic Patients
Cardiogenic Shock, Pulmonary Edema Cardiac Cause
Not yet recruitingPhase 4
Capital Offload-Shock
Hypervolemia, Cardiogenic Shock
Recruiting
CRP Apheresis in Infarct-Related Cardiogenic Shock
Cardiogenic Shock, Acute Myocardial Infarction (AMI)
RecruitingObservational study
Cardiogenic Shock Working Group Registry
Cardiogenic Shock

All Cardiogenic Shock trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study on the Safety and Efficacy of Istaroxime for Pre-Cardiogenic Shock (SEISMiC)
ClinicalTrials.gov ID: NCT04325035
Acronym / sponsor ID: SEISMiC / 04-CL-1904
Conditions: Cardiogenic Shock
Keywords: Pre-cardiogenic shock, Heart failure
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 90 participants (actual)
Lead sponsor: Windtree TherapeuticsIndustry (pharma, biotech, devices)
Collaborators: Momentum Research, Inc.
Study start: 28 Sep 2020 (actual)
Primary completion: 26 Sep 2024 (actual)
Study completion: 30 Oct 2024 (actual)
First posted: 27 Mar 2020 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Up to 30 sites in Part A; up to 15 sites in Part B. Sites may be located in Europe, Asia, South America, and North America.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 5

Arm	Type	Receives
Istaroxime - Part A	Experimental	Drug: IstaroximeIstaroxime IV infusion for 24 hours. Istaroxime administration can begin at 1.0 or 1.5 µg/kg/min; the target infusion rate is 1.5 µg/kg/min
Placebo - Part A	Placebo comparator	Drug: PlaceboPlacebo (lactose lyophilized powder) IV infusion for 24 hours
Istaroxime - Part B	Experimental	Drug: IstaroximeIstaroxime IV infusion at 1.0 µg/kg/min for 6 hours, 0.5 µg/kg/min for 42 hours, 0.25 µg/kg/min for 12 hours.
Istaroxime and Placebo - Part B	Experimental	Drug: Istaroxime, Drug: PlaceboIstaroxime IV infusion at 0.5 µg/kg/min for 48 hours, followed by placebo IV infusion for 12 hours.
Placebo - Part B	Placebo comparator	Drug: PlaceboPlacebo (lactose lyophilized powder) IV infusion for 60 hours.

Who may qualify

Ages: 18 to 85 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (13 listed)

Clinical presentation consistent with SCAI Stage B pre-cardiogenic shock caused by acute decompensation of chronic systolic heart failure (due to arterial hypertension, ischemic heart disease or dilated cardiomyopathy), without evidence for an acute coronary syndrome.
Signed informed consent form (ICF);
Males and females, 18 to 85 years of age (inclusive);
An admission for acute decompensated heart failure (ADHF) episode within 36 hours prior to randomization, defined as:
History of left ventricular ejection fraction (LVEF) ≤ 40%;

Key exclusion criteria (32 listed)

Cardiogenic shock of SCAI Stage C or worse
Cardiogenic shock due to any other condition besides acute decompensation of chronic heart failure.
Any of the following in the past 30 days: acute coronary syndrome, coronary revascularization, myocardial infarction (MI), coronary artery bypass graft (CABG), or percutaneous coronary intervention;
Current (within 6 hours of Screening) or anticipated need for treatment with positive inotropic agents or vasopressors, renal support including ultrafiltration, or mechanical circulatory, ventilatory or renal support (intra-aortic balloon pump, endotracheal intubation, mechanical ventilation, or any ventricular assist device);
Venous Lactate > 2 mmol/L;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
IstaroximeAlso: PST2744Reconstituted istaroxime and lactose lyophilized powder delivered via IV infusion	Drug	Istaroxime - Part A, Istaroxime - Part B, Istaroxime and Placebo - Part B
PlaceboAlso: Lactose lyophilized powderReconstituted placebo (lactose lyophilized powder) delivered via IV infusion	Drug	Istaroxime and Placebo - Part B, Placebo - Part A, Placebo - Part B

Primary outcome

Change from baseline in systolic blood pressure (SBP) area under the curve (AUC) 0-6
Time frame: 0 to 6 hours after initiation of infusion
Change from baseline AUC for systolic blood pressure

29 secondary outcomes

Change from baseline in SBP AUC 0-48
Time frame: 0 to 60 hours after initiation of infusion
Change from baseline in SBP AUC 0-60
Time frame: 0 to 48 hours after initiation of infusion
Treatment failure score
Time frame: 60 hours from initiation of infusion
Change from baseline in SBP
Time frame: 6 hours after initiation of infusion
Change from baseline in SBP
Time frame: 24 hours after initiation of infusion
Change from baseline in SBP
Time frame: 48 hours after initiation of infusion
Change from baseline in SBP
Time frame: 60 hours after initiation of infusion
Number of treatment failures
Time frame: Randomization to 24 hours for Part A
Number of treatment failures
Time frame: Randomization to 48 hours for Part B
Number of treatment failures
Time frame: Randomization to Day 5
Change in quality of life
Time frame: Baseline to Day 5 (96 hours) from infusion start
Change in quality of life
Time frame: Baseline to Day 30 from infusion start
Change in eGFR
Time frame: 24 hours from infusion start
Change in eGFR
Time frame: 48 hours from infusion start
Change in brain natriuretic peptide (BNP), N-terminal pro hormone B-type natriuretic peptide (NT-pro-BNP), troponin (cTn; either T or I) and venous lactate
Time frame: 24 hours from infusion start
Change in brain natriuretic peptide (BNP), N-terminal pro hormone B-type natriuretic peptide (NT-pro-BNP), troponin (cTn; either T or I) and venous lactate
Time frame: 48 hours from infusion start
Time to worsening heart failure (HF)
Time frame: Up to Day 5
Time to HF re-admission or death
Time frame: Up to Day 30
Length of initial hospitalization
Time frame: Up to Day 30
Days alive and out of the hospital
Time frame: Up to Day 30
Mortality and reasons for death
Time frame: Up to Day 30
Change in coronary index (CI)
Time frame: 24 hours
Change in E to e' ratio
Time frame: 24 hours
Change in stroke volume index (SVI)
Time frame: 24 hours
Change in left atrium area (LAA)
Time frame: 24 hours
Change in CI
Time frame: 48 hours
Change in E to e' ratio
Time frame: 48 hours
Change in SVI
Time frame: 48 hours
Change in LAA
Time frame: 48 hours

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2025.
Results publication: PubMed 35867804Metra M, Chioncel O, Cotter G, Davison B, Filippatos G, Mebazaa A, Novosadova M, Ponikowski P, Simmons P, Soffer J, Simonson S. 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). Eur J Heart Fail. 2022 Oct;24(10):1967-1977. doi: 10.1002/ejhf.2629. Epub 2022 Aug 22.
Results publication: PubMed 37075941Metra M, Chioncel O, Davison B, Filippatos G, Mebazaa A, Pagnesi M, Adamo M, Novosadova M, Ponikowski P, Simmons P, Soffer J, Simonson S, Cotter G. Safety and Efficacy of Istaroxime 1.0 and 1.5 microg/kg/min for Patients With Pre-Cardiogenic Shock. J Card Fail. 2023 Jul;29(7):1097-1103. doi: 10.1016/j.cardfail.2023.03.020. Epub 2023 Apr 17.
Individual participant dataSharing planned: No

Related trials for Cardiogenic Shock

RecruitingObservational study
Evaluation of Acid-base Disorders and Ventilation Settings in Cardiogenic Shock and Post-cardiac Arrest Patients: Comparison With VentilO Algorithm
Cardiac Arrest (CA), Cardiogenic Shock
Not yet recruitingObservational study
Hemodynamic Evaluation of Left Atrial Pressure in Relationship to Pulmonary Capillary Wedge Pressure in Cardio Thoracic Patients
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Cardiogenic Shock Working Group Registry
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Marco Metra, MD principal investigator

Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia, Italy

13 sites in 4 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Istaroxime in people with Cardiogenic Shock, run by Windtree Therapeutics at 13 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in Argentina, Poland, Italy, United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline in systolic blood pressure (SBP) area under the curve (AUC) 0-6 (time frame: 0 to 6 hours after initiation of infusion). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04325035, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2025.