Cardiogenic ShockPhase 2/3RESCUE HF-CSNCT07583446
Randomized Evaluation of Istaroxime for Stabilization in Acute Heart Failure-Cardiogenic Shock
A Phase 2/3 study testing istaroxime in people with Cardiogenic Shock, run by Seismic Pharmaceuticals Operations LLC at 1 site in Armenia.
Trial summary
The goal of this clinical trial is to learn if the drug istaroxime works to treat cardiogenic shock due to acute heart failure in adults. It will also learn about the safety of istaroxime. Read more about this study
- Who is it for?
- Ages 18 to 80 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
- 600 participants
- Where
- 1 siteArmenia
- Study dates
- 9 Sep 2026to Dec 2028
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged between 18 and 80 years old (inclusive) at the time of informed consent, regardless of gender.
- Diagnosed with CS due to AHF during screening, before randomization, and meeting all of the following criteria:
- Dyspnea at rest or with minimal activity before screening and randomization.
- Pulmonary rales, or lower limb edema by physical examination.
- Evidence of pulmonary congestion by chest X-ray, CT scan or lung ultrasound
- At the time of screening and just prior to randomization either:
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- systolic BP ≤ 100 mmHg or
- systolic BP ≤ 115 mmHg and >100 mmHg accompanied by at least one sign of hypoperfusion or hemodynamic compromise: cool extremities, altered mentation attributable to low output, oliguria, elevated lactate (>2 mmol/L), worsening renal function attributable to low perfusion, or invasive/noninvasive hemodynamic evidence of reduced cardiac output.
- Initial hospitalization (defined as first medical contact in the hospital) for this AHF event within 20 hours before randomization.
- Documented history within 6 months prior to screening, or during the current admission, of left ventricular ejection fraction (LVEF) < 40%.
- N-terminal pro-B-type natriuretic peptide (NT-proBNP) > 1,500 pg/mL or BNP > 400 pg/mL during screening, before randomization.
- Signed informed consent, including compliance with the requirements and restrictions listed in the informed consent form (ICF) and the study protocol.
Who cannot join
- Body weight < 40 kg or ≥ 150 kg at Screening.
- Rapidly deteriorating cardiogenic shock requiring escalating support
- Patients with any systolic blood pressure measurement >130 mmHg within 2 hours prior to randomization.
- Administration during the 6 hours prior to screening of vasodilators such as nitroglycerin, nitrates, recombinant human brain natriuretic peptide.
- Received digoxin within 7 days before randomization.
- Taking a medication that is a substrate of cytochrome P450 2C19 (CYP2C19).
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- Patients with severe lung disease (dependent on oral steroids or immunosuppressive therapy or require home oxygen therapy), respiratory failure, or severe pulmonary hypertension.
- Acute ischemic or hemorrhagic cerebral infarction or transient ischemic attack within 30 days before screening.
- Abnormal laboratory findings including during screening:
- Renal impairment (eGFR < 25 ml/min/1.73 m2) or the need for long-term or intermittent renal support therapy (hemodialysis, ultrafiltration or peritoneal dialysis);
- Severe electrolyte imbalance (Na+ <120mmol/L or >160mmol/L, and/or K+ <3.2mmol/L or >5.5mmol/L);
- Liver function impairment (ALT and/or AST > 3 times the upper limit of the normal range and/or bilirubin exceeds 1.5 times the upper limit of the normal range); or
- Hemoglobin <9 g/dL (<5.6 mmol/L).
- Severe valvular stenosis that has not been surgically corrected, or moderate or severe aortic regurgitation.
- Obstructive hypertrophic cardiomyopathy or restrictive cardiomyopathy, constrictive pericarditis, cardiac tamponade, cardiomyopathy based on infiltrative disease (such as amyloidosis), accumulation disease (such as hemochromatosis, Fabry disease), myocardial dysplasia, cardiomyopathy caused by reversible causes (such as stress cardiomyopathy) or acute myocarditis.
- Sustained ventricular tachycardia or ventricular fibrillation within 30 days of screening and randomization.
- Significant bradycardia (sustained ventricular rate <50 beats per minute), or second or third-degree atrioventricular block (except those using permanent pacemakers).
- Type 1 acute coronary syndrome (ACS)/myocardial infarction (MI) in the 30 days prior to screening inclusive of the current admission.
- Patients who have undergone percutaneous coronary angiography or coronary artery bypass grafting or other major cardiovascular surgery including ICD and / or CRT or mechanical support devices within one month before screening, or patients who are expected to require revascularization within three months after screening.
- Patients on mechanical circulatory support (MCS) during Screening or at the time of randomization.
- Patients who are expected to require heart transplantation or left ventricular assist during the study period.
- Patients diagnosed with malignant tumors within 1 year before signing the informed consent form or at the time of screening (excluding fully treated cervical carcinoma in situ, basal cell or squamous cell skin cancer, localized prostate cancer after radical surgery, and breast ductal carcinoma in situ after radical surgery), or those undergoing anti-tumor treatment at the time of screening.
- Patients with diseases that in the opinion of the investigator may lead to mortality within 90 days from randomization.
- Patients who suffer from severe mental or psychological disorders, cognitive impairment, or a history of mental illness.
- Patients with known severe allergies or a history of severe drug or food allergic reactions, or those known to be allergic to istaroxime or its ingredients including lactose.
- Patients who are pregnant, breastfeeding or planning pregnancy.
- Patients who cannot be guaranteed to take effective contraceptive measures from the time of signing the informed consent to the 30 days following their last exposure to study drug, or who are of childbearing potential and plan to donate sperm/eggs during this period.
- Patients of childbearing potential without a negative highly sensitive serum pregnancy test within 24 hours before the first dose of trial intervention.
- Patients participating in other clinical studies and/or received other study intervention (study drugs or medical devices, etc.) within 30 days before signing the informed consent form, or who are still in the follow up period of other clinical studies.
- Patients who are unable to comply with all study requirements.
- Any other circumstances deemed by the investigator to be inappropriate for conducting this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Armenia1 site, 1 recruiting
- Recruiting
Institute of Surgery Mikayelyan CJSC
Yerevan, 0052
Andranik Mshetsyan, MD, andranikmshetsyan@gmail.com
About this study
Official title: A Randomized, Double-blind, Phase 2b/3 Clinical Study of Istaroxime Combined With Standard Care Versus Placebo and Standard of Care for the Treatment of Cardiogenic Shock (CS) Society for Cardiovascular Angiography and Interventions (SCAI) Stage B or C Due to Acute Heart Failure (AHF)
The goal of this clinical trial is to learn if the drug istaroxime works to treat cardiogenic shock due to acute heart failure in adults. It will also learn about the safety of istaroxime. Researchers will compare istaroxime to a placebo (a look-alike substance that contains no drug) to see if istaroxime works to treat cardiogenic shock due to acute heart failure.
The main questions it aims to answer are:
Read more
- Does istaroxime relieve participants' shortness of breath compared to a placebo?
- Does istaroxime provide clinical benefit in terms of lowering the risk of dying, having invasive procedures, being rehospitalized or having worsening heart failure, and/or increasing quality of life compared to a placebo?
- Does istaroxime reduce the duration of the initial hospital stay compared with placebo?
Participants will:
- Receive a 48-hour intravenous infusion of istaroxime or placebo with possible additional retreatment depending on their clinical condition
- Complete questionnaires rating their breathing and describing their quality of life
- Return for visits 30 and 90 days after the start of Cycle 1 infusion. The trial will end when the last participant completes Day 30 and all participants have been followed for at least 30 days after their last IMP exposure. At trial termination, participants who have not been followed to Day 90 will have an end-of-study (EOS) visit.
- Conditions
- Cardiogenic Shock
- Being tested
- istaroxime, placebo
- Medical subject headings
- Shock, Cardiogenic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
istaroximeDrug
intravenous istaroxime
placeboDrug
intravenous placebo
| Study group | Role | What they receive |
|---|---|---|
| istaroxime | Experimental | Participants will receive istaroxime by continuous intravenous infusion. Receives: Drug: istaroxime |
| placebo | Placebo comparator | Participants will receive placebo (normal saline) by continuous intravenous infusion. Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in participant-reported dyspnea
Area under the curve (AUC) of change from baseline in dyspnea visual analog scale (VAS) score (0-100; higher scores indicate better breathing).
Measured: 24 hours
Hierarchical composite endpoint
Hierarchical composite of (1) time to all-cause death; (2) time to first initiation of new mechanical circulatory support, urgent durable LVAD implantation or heart transplantation, or invasive mechanical respiratory support; (3) time to first heart failure rehospitalization or worsening heart failure; and (4) change from baseline in EQ-VAS score (0-100; higher scores indicate better health).
Measured: 30 days; EQ-VAS change from baseline to 48 hours
Secondary outcomes (1)
Length of hospital stay
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2026
- Study start9 Sep 2026
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seismic Pharmaceuticals Operations LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gabe Coitler, Principal investigator, Seismic Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07583446
- Sponsor's protocol ID
- Seismic-Ista-001
- Acronym
- RESCUE HF-CS
- Status last verified
- Sep 2026
- First submitted
- 1 May 2026
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Phase 2b/3 Clinical Study of Istaroxime Combined With Standard Care Versus Placebo and Standard of Care for the Treatment of Cardiogenic Shock (CS) Society for Cardiovascular Angiography and Interventions (SCAI) Stage B or C Due to Acute Heart Failure (AHF)
- ClinicalTrials.gov ID
- NCT07583446
- Acronym / sponsor ID
- RESCUE HF-CS / Seismic-Ista-001
- Conditions
- Cardiogenic Shock
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Seismic Pharmaceuticals Operations LLCIndustry (pharma, biotech, devices)
- Study start
- 9 Sep 2026 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 13 May 2026 (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.
The goal of this clinical trial is to learn if the drug istaroxime works to treat cardiogenic shock due to acute heart failure in adults. It will also learn about the safety of istaroxime. Researchers will compare istaroxime to a placebo (a look-alike substance that contains no drug) to see if istaroxime works to treat cardiogenic shock due to acute heart failure.
The main questions it aims to answer are:
- Does istaroxime relieve participants' shortness of breath compared to a placebo?
- Does istaroxime provide clinical benefit in terms of lowering the risk of dying, having invasive procedures, being rehospitalized or having worsening heart failure, and/or increasing quality of life compared to a placebo?
- Does istaroxime reduce the duration of the initial hospital stay compared with placebo?
Participants will:
- Receive a 48-hour intravenous infusion of istaroxime or placebo with possible additional retreatment depending on their clinical condition
- Complete questionnaires rating their breathing and describing their quality of life
- Return for visits 30 and 90 days after the start of Cycle 1 infusion. The trial will end when the last participant completes Day 30 and all participants have been followed for at least 30 days after their last IMP exposure. At trial termination, participants who have not been followed to Day 90 will have an end-of-study (EOS) visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| istaroxime | Experimental | Drug: istaroximeParticipants will receive istaroxime by continuous intravenous infusion. |
| placebo | Placebo comparator | Drug: placeboParticipants will receive placebo (normal saline) by continuous intravenous infusion. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Aged between 18 and 80 years old (inclusive) at the time of informed consent, regardless of gender.
- Diagnosed with CS due to AHF during screening, before randomization, and meeting all of the following criteria:
- Initial hospitalization (defined as first medical contact in the hospital) for this AHF event within 20 hours before randomization.
- Documented history within 6 months prior to screening, or during the current admission, of left ventricular ejection fraction (LVEF) < 40%.
- N-terminal pro-B-type natriuretic peptide (NT-proBNP) > 1,500 pg/mL or BNP > 400 pg/mL during screening, before randomization.
Key exclusion criteria (31 listed)
- Body weight < 40 kg or ≥ 150 kg at Screening.
- Rapidly deteriorating cardiogenic shock requiring escalating support
- Patients with any systolic blood pressure measurement >130 mmHg within 2 hours prior to randomization.
- Administration during the 6 hours prior to screening of vasodilators such as nitroglycerin, nitrates, recombinant human brain natriuretic peptide.
- Received digoxin within 7 days before randomization.
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 |
|---|---|---|
| istaroximeintravenous istaroxime | Drug | istaroxime |
| placebointravenous placebo | Drug | placebo |
Primary outcome
Change in participant-reported dyspnea
Time frame: 24 hours
Area under the curve (AUC) of change from baseline in dyspnea visual analog scale (VAS) score (0-100; higher scores indicate better breathing).
Hierarchical composite endpoint
Time frame: 30 days; EQ-VAS change from baseline to 48 hours
Hierarchical composite of (1) time to all-cause death; (2) time to first initiation of new mechanical circulatory support, urgent durable LVAD implantation or heart transplantation, or invasive mechanical respiratory support; (3) time to first heart failure rehospitalization or worsening heart failure; and (4) change from baseline in EQ-VAS score (0-100; higher scores indicate better health).
1 secondary outcome
Length of hospital stay
Time frame: 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2026.
- Individual participant dataSharing planned: Undecided
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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.
Gabe Coitler principal investigator
Seismic Pharmaceuticals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing istaroxime in people with Cardiogenic Shock, run by Seismic Pharmaceuticals Operations LLC at 1 site in Armenia.
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 12 inclusion and 31 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: looking for participants now, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Armenia. 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gad Cotter, MD (919-317-2993, Meghnapatel@momentum-research.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in participant-reported dyspnea (time frame: 24 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Sep 2026.