Randomized Evaluation of Istaroxime for Stabilization in Acute Heart Failure-Cardiogenic Shock (NCT07583446) | Clinical Trial Compass
Not Yet RecruitingPhase 2/3
Randomized Evaluation of Istaroxime for Stabilization in Acute Heart Failure-Cardiogenic Shock
600 participantsStarted 2026-07
Plain-language summary
The goal of this clinical trial is to learn if the drug istaroxime works to treat mild to moderate cardiogenic shock due to acute heart failure in adults. It will also learn about the safety of istaroxime. 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, having worsening heart failure, and/or increasing quality of life compared to a placebo?
* Does istaroxime increase blood pressure compared to a placebo? Researchers will compare istaroxime to a placebo (a look-alike substance that contains no drug) to see if istaroxime works to treat mild to moderate cardiogenic shock due to acute heart failure.
Participants will:
* Receive a 48-hour intravenous infusion of istaroxime or placebo
* Complete questionnaires rating their breathing and describing their quality of life
* Return for a visit 30 and 90 days after the initial drug infusion was started
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Aged between 18 and 80 years old (inclusive) at the time of informed consent, regardless of gender.
. Diagnosed with CS SCAI B or C due to AHF during screening, before randomization, as defined by:
. 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:
. systolic BP ≤ 100 mmHg or
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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.
Exclusion criteria
. Body weight \< 40 kg or ≥ 150 kg at Screening.
. Society for Cardiovascular Angiography and Interventions (SCAI) level D or more severe cardiogenic shock during screening, prior to randomization.
. 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
. Prescription of digoxin within 7 days before randomization.
. 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: