BridgeMD
A Multicenter, Randomized, Placebo-Controlled, Parallel Group Trial on the Safety and Efficacy of Istaroxime for Cardiogenic Shock SCAI Stage C (SEISMiC-C)
EU CTIS ID: 2023-507243-11-02
What this study is testing
The primary objective of this trial is to assess the ability of istaroxime to increase SBP in patients with Society for Cardiovascular Angiography and Interventions (SCAI) Stage C cardiogenic shock, defined as hospitalization for acute decompensated heart failure (ADHF) with persistent hypotension, and since admission to the hospital and throughout screening, have not received digoxin and are not on cardiovascular, respiratory, or renal mechanical support.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Signed informed consent form (ICF)
- Clinical presentation consistent with SCAI Stage C cardiogenic shock caused by ADHF and meeting the criteria in Table 5 1.
- Admitted to ICU within 36 hours prior to randomization with pulmonary congestion on chest x-ray (airspace opacification, Kerley B lines, pleural effusion, etc.) or lung ultrasound (B-lines) and BNP ≥ 400 pg/mL or NT-proBNP ≥ 1400 pg/mL
- Males and females, 18 to 85 years of age (inclusive).
- History of left ventricular ejection fraction (LVEF) ≤ 40%.
- Persistent hypotension defined as SBP between 70 and 90 mmHg for 2 readings with concomitant signs of hypoperfusion.
You likely can't join if
- Patient is in SCAI B (BP increased above 90 mmHg despite no vasoactive or inotrope therapy) or SCAI D (continuously deteriorating BP and hypoperfusion despite vasoactive or inotrope therapy).
- Stroke or TIA within 3 months.
- Severe obstructive valvular lesions including severe aortic or mitral stenosis.
- 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 COPD, planned admission for device implantation, or over-diuresis as a cause of hypotension.
- Pericardial constriction or active pericarditis.
See the full eligibility criteria
- Signed informed consent form (ICF)
- Clinical presentation consistent with SCAI Stage C cardiogenic shock caused by ADHF and meeting the criteria in Table 5 1.
- Admitted to ICU within 36 hours prior to randomization with pulmonary congestion on chest x-ray (airspace opacification, Kerley B lines, pleural effusion, etc.) or lung ultrasound (B-lines) and BNP ≥ 400 pg/mL or NT-proBNP ≥ 1400 pg/mL
- Males and females, 18 to 85 years of age (inclusive).
- History of left ventricular ejection fraction (LVEF) ≤ 40%.
- Persistent hypotension defined as SBP between 70 and 90 mmHg for 2 readings with concomitant signs of hypoperfusion.
- Echocardiogram during initial hospitalization confirming ejection fraction ≤ 40% and no evidence of other pathology to confound interpretation of cardiac physiology (eg, pericardial effusion).
- Patient is in SCAI B (BP increased above 90 mmHg despite no vasoactive or inotrope therapy) or SCAI D (continuously deteriorating BP and hypoperfusion despite vasoactive or inotrope therapy).
- Stroke or TIA within 3 months.
- Severe obstructive valvular lesions including severe aortic or mitral stenosis.
- 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 COPD, planned admission for device implantation, or over-diuresis as a cause of hypotension.
- Pericardial constriction or active pericarditis.
- Significant ventricular arrhythmia prior to screening (such as sustained ventricular tachycardia or ventricular fibrillation) 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 within the past month.
- Uncontrolled arrythmia.
- Sustained hypotension (SBP < 70 mmHg) for at least 30 minutes from the time of arrival to the hospital.
- Systolic BP > 120 mmHg during the hour prior to randomization.
- Lactate < 2 mmol/L (unless the patient meets the criteria in bullet 2 of Table 5-1) or lactate > 5 mmol/L prior to randomization.
- 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° or active infection requiring IV antimicrobial treatment.
- Body weight < 40 kg or ≥ 150 kg.
- Laboratory exclusions: a. Hemoglobin < 9 g/dl, b. Platelet count < 100,000/µl, c. Serum potassium > 5.3 mmol/l or < 3.5 mmol/l.
- A life expectancy < 3 months based on the judgment of the investigator.
- Severe pulmonary or thyroid disease.
- Pregnant, planning on becoming pregnant, or currently breast-feeding.
- Ongoing drug or alcohol abuse.
- Participation in another interventional trial within the past 30 days.
- 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, MI, CABG, or percutaneous coronary intervention.
- Current (within 6 hours of screening) or anticipated need for treatment with renal support including ultrafiltration, or mechanical circulatory, ventilatory or renal support (intra-aortic balloon pump, endotracheal intubation, mechanical ventilation, or any ventricular assist device) such as persistent hypoperfusion and hypotension.
- History of heart transplant or UNOS priority 1a heart transplant listing.
- 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 (eGFR < 30 ml/min, calculated by the MDRD formula).
- Hypersensitivity to the trial medication and its excipients (including known lactose hypersensitivity) or any related medication.
The study team makes the final eligibility decision.
Where it's taking place
- Armenia
- Israel
- Argentina
- United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Armenia; Israel; Argentina; United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.