← Back to Search

Cardiac Glycoside

Istaroxime for Cardiogenic Shock (SEISMiC Trial)

Phase 2
Waitlist Available
Led By Marco Metra, MD
Research Sponsored by Windtree Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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)
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 60 hours from initiation of infusion
Awards & highlights

SEISMiC Trial Summary

This trial is testing a new treatment for heart failure. Patients in the trial will be randomly assigned to receive either the new treatment or a placebo. The trial will measure how well the new treatment works and how safe it is.

Who is the study for?
This trial is for adults aged 18-85 hospitalized with acute heart failure and low blood pressure, but not in full-blown shock. They must have a history of reduced heart function due to conditions like high blood pressure or heart disease, without recent severe cardiac events or procedures. Participants need an ejection fraction ≤40% and can't be on certain medications or require intensive support like mechanical ventilation.Check my eligibility
What is being tested?
The study tests Istaroxime's safety and effectiveness against a placebo in preventing cardiogenic shock in patients with worsening chronic heart failure. It's a pilot, multinational trial where participants are randomly assigned to receive either the drug or placebo, without knowing which one they're getting (double-blind).See study design
What are the potential side effects?
While specific side effects for Istaroxime aren't listed here, similar drugs may cause issues such as irregular heartbeat, changes in blood pressure, headaches, nausea, and potential allergic reactions. The severity of side effects varies from person to person.

SEISMiC Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have low blood pressure and a heart rate within the specified range, with a confirmed heart function issue but no other heart problems.
Select...
I have early signs of heart failure shock not caused by a heart attack.

SEISMiC Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~60 hours from initiation of infusion
This trial's timeline: 3 weeks for screening, Varies for treatment, and 60 hours from initiation of infusion for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from baseline in systolic blood pressure (SBP) area under the curve (AUC) 0-6
Secondary outcome measures
Change from baseline in SBP
Change from baseline in SBP AUC 0-48
Change from baseline in SBP AUC 0-60
+17 more

SEISMiC Trial Design

5Treatment groups
Experimental Treatment
Placebo Group
Group I: Istaroxime and Placebo - Part BExperimental Treatment2 Interventions
Istaroxime IV infusion at 0.5 µg/kg/min for 48 hours, followed by placebo IV infusion for 12 hours.
Group II: Istaroxime - Part BExperimental Treatment1 Intervention
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.
Group III: Istaroxime - Part AExperimental Treatment1 Intervention
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
Group IV: Placebo - Part BPlacebo Group1 Intervention
Placebo (lactose lyophilized powder) IV infusion for 60 hours.
Group V: Placebo - Part APlacebo Group1 Intervention
Placebo (lactose lyophilized powder) IV infusion for 24 hours
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lactose
FDA approved
Istaroxime
Not yet FDA approved

Find a Location

Who is running the clinical trial?

Momentum Research, Inc.Industry Sponsor
6 Previous Clinical Trials
7,579 Total Patients Enrolled
Windtree TherapeuticsLead Sponsor
16 Previous Clinical Trials
1,374 Total Patients Enrolled
Marco Metra, MDPrincipal InvestigatorAzienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia, Italy
5 Previous Clinical Trials
4,616 Total Patients Enrolled

Media Library

Istaroxime (Cardiac Glycoside) Clinical Trial Eligibility Overview. Trial Name: NCT04325035 — Phase 2
Cardiogenic Shock Research Study Groups: Placebo - Part B, Placebo - Part A, Istaroxime - Part B, Istaroxime - Part A, Istaroxime and Placebo - Part B
Cardiogenic Shock Clinical Trial 2023: Istaroxime Highlights & Side Effects. Trial Name: NCT04325035 — Phase 2
Istaroxime (Cardiac Glycoside) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04325035 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research involve participants of a younger age demographic?

"Patients who meet the entry requirements for this trial must be 18 to 85 years old. Separately, there are 15 trials catered specifically towards minors and 136 clinical studies intended for seniors aged 65 or higher."

Answered by AI

Has the FDA sanctioned utilization of Istaroxime - Part A?

"As this is a Phase 2 trial, Istaroxime - Part A has been evaluated as having an intermediate safety rating of two; while there exists some evidence supporting its security, no data supports the efficacy of the drug."

Answered by AI

How many facilities are actively managing the research for this investigation?

"At this point in time, 24 medical centres are looking for individuals to participate in the study. These clinics can be found across cities such as Boston, Charleston and Alessandria. It is suggested that you select a location near your residence if possible, so that the travel burden on yourself is minimised."

Answered by AI

What is the magnitude of involvement in this research endeavor?

"Sadly, no; this study is no longer recruiting patients. This trial was initially posted on September 28th 2020 and last edited August 7th 2023. For those searching for other clinical trials relating to cardiogenic shock, there are 142 active studies that can be explored, in addition to 9 particular Istaroxime - Part A investigations currently accepting participants."

Answered by AI

What characteristics do potential participants need to possess in order for them to be suitable candidates for this experiment?

"This study is open to 90 individuals aged 18-85 with cardiogenic shock. Necessary conditions for participation include: signing an informed consent form; being of either gender within the aforementioned age range; displaying dyspnea at rest or mild activity, as evidenced by chest x-ray and BNP/NT-proBNP levels; having a left ventricular ejection fraction (LVEF) lower than 40%; SBP between 75-90 mmHg during the last 2 hours preceding randomization without decreasing more than 7 mmHg on two occasions in that period; heart rate from 60 to 150 bpm depending on"

Answered by AI

Are there any available openings to participate in this investigation?

"According to the most recent information on clinicaltrials.gov, this trial is not actively enrolling patients at present. Initially posted on September 28th 2020 and last edited on August 7th 2023, there are currently 151 other medical studies in search of participants."

Answered by AI

To what ailments is Istaroxime - Part A typically prescribed?

"Istaroxime-Part A is frequently utilised to treat opioid addiction, as well as adrenal cortex hormones deficiencies, bronchodilator agents, and chronic obstructive pulmonary disease."

Answered by AI

Could you elucidate what other studies have been performed using Istaroxime - Part A?

"During 2015, the first trials of istaroxime - Part A were conducted at Georgia Regents University. As of now, 19317 clinical tests have been finalized. Furthermore, 9 studies are presently accepting sign-ups with many located in Boston and South carolina."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
The Safety and Efficacy of Istaroxime for Pre-Cardiogenic Shock
2020. "The Safety and Efficacy of Istaroxime for Pre-Cardiogenic Shock". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04325035.
~20 spots leftby Apr 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top