Left Ventricular Unloading to Improve Outcome in Cardiogenic Shock Patients on VA-ECMO

Cardiogenic Shock Clinical Trial

Official title:

UNLOAD ECMO - Left Ventricular Unloading to Improve Outcome in Cardiogenic Shock Patients on VA-ECMO - a Prospective, Randomized, Controlled, Multi-center Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05577195
• Other study ID #: UNLOAD ECMO
• Status: Recruiting
• Phase: N/A
• Start date: November 17, 2022
• Est. completion date: December 1, 2025

Study information

• Verified date: December 2022
• Source: Universitätsklinikum Hamburg-Eppendorf
• Contact: Dirk Westermann, Prof.
• Phone: 0049 40 7410 0
• Email: d.westermann[@]uke.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Prospective, multi-center, randomized (1:1), controlled trial of Impella for active left ventricular unloading on top of veno-arterial extracorporeal membrane oxygenation vs. veno-arterial extracorporeal membrane oxygenation alone for the treatment of cardiogenic shock.

Description:

In the past years extensive efforts in developing treatment strategies for patients with cardiogenic shock have been performed. One promising such strategy is active unloading of the left ventricle while simultaneously supporting the circulatory system with veno-arterial extracorporeal membrane oxygenation. Recently, in a multinational, multicenter, retrospective registry, it has been shown that this approach might be associated with lower mortality .

The investigators now seek to extend the evidence on this topic and to test this approach in a prospective, randomized, controlled, multicenter trial. A power calculation has been conducted based on the data from the registry. N=198 patients with cardiogenic shock will be randomized 1:1 to be either treated with an Impella for active left ventricular unloading on top of veno-arterial extracorporeal membrane oxygenation or with veno-arterial extracorporeal membrane oxygenation alone. A blinded interim analysis will be performed, which might lead to an adjustment of the enrollment target. The primary endpoint of this study will be death from any cause 30 days after randomization.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 198
• Est. completion date: December 1, 2025
• Est. primary completion date: November 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

Severe cardiogenic shock due to severe left ventricular dysfunction:

• Systolic blood pressure <90 mmHg or need for catecholamines to maintain such blood pressure

• Signs of impaired organ perfusion with at least one of the following: altered mental status OR cold, clammy skin OR oliguria with urine output <30 ml/h

• Arterial lactate >5 mmol/l

Exclusion Criteria:

• Post-cardiotomy cardiogenic shock.

• Cardiogenic shock due to acute rejection in heart transplant recipients.

• Obstructive cardiogenic shock (e.g. cardiogenic shock due to fulminant pulmonary embolism)

• Cardiogenic shock due to other causes (e.g. bleeding, hypothermia)

• Pre-existing Impella treatment.

• Onset of shock >12 hours.

• Mechanical complication of acute myocardial infarction.

• Prolonged resuscitation (>60 minutes).

• Severe peripheral artery disease with infeasibility for Impella or veno-arterial extracorporeal membrane oxygenation implantation.

• Age <18 or >80 years.

• Other severe concomitant disease with life expectancy <6 months.

• Participation in another trial with an intervention or pregnancy.

Related Conditions & MeSH terms

• Cardiogenic Shock
• Shock
• Shock, Cardiogenic

Intervention

Device:
• Impella
To provide active left ventricular unloading in the experimental arm
• VA-ECMO
To provide circulatory support in both arms

Locations

Country	Name	City	State
Germany	University Heart and Vascular Center Hamburg	Hamburg

Sponsors (1)

Lead Sponsor	Collaborator
Universitätsklinikum Hamburg-Eppendorf

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to death from any-cause within 30 days after randomization	Time to death from any-cause within 30 days after randomization	30 days
Secondary	Death from any-cause at 6 and 12 months as well as time to death at these time points	Cardiovascular death at day 30, 6 months and 12 months as well as time to death at these time points	6 and 12 months
Secondary	Cardiovascular death at day 30, 6 months and 12 months as well as time to death at these time points	Cardiovascular death at day 30, 6 months and 12 months as well as time to death at these time points	30 days, 6 and 12 months
Secondary	Length of veno-arterial extracorporeal membrane oxygenation therapy, mechanical ventilation, inotrope therapy and stay at the intensive care unit (in days).	Length of veno-arterial extracorporeal membrane oxygenation therapy, mechanical ventilation, inotrope therapy and stay at the intensive care unit (in days).	12 months
Secondary	Days free from veno-arterial extracorporeal membrane oxygenation therapy in 30 days	Days free from veno-arterial extracorporeal membrane oxygenation therapy in 30 days	30 days
Secondary	Need for renal replacement therapy until day 30, 6 months and 12 months	Need for renal replacement therapy, intermittent or ongoing, until day 30, 6 months and 12 months	30 days, 6 and 12 months
Secondary	Neurological function (per Cerebral Performance Category) at day 30, 6 months and 12 months	Neurological function (per Cerebral Performance Category) at day 30, 6 months and 12 months	30 days, 6 and 12 months
Secondary	Rate of incidence of hospitalization for heart failure (hospitalization for more than 24 hours with heart failure as the main reason) as well as time to first event after 6 months and 12 months and recurrent events within 12 months	Rate of incidence of hospitalization for heart failure (hospitalization for more than 24 hours with heart failure as the main reason) as well as time to first event after 6 months and 12 months and recurrent events within 12 months	6 and 12 months
Secondary	Left ventricular function assessed by echocardiography at day 30, 6 months and 12 months	Left ventricular function assessed by echocardiography at day 30, 6 months and 12 months	30 days, 6 and 12 months
Secondary	Quality of life as assessed by the "Kansas City Cardiomyopathy Questionnaire" at 30-days and at 12 months	Quality of life as assessed by the "Kansas City Cardiomyopathy Questionnaire" at 30-days and at 12 months	30 days and 6 months
Secondary	6-Minute Walking Distance at day 30, 6 months and 12 months	6-Minute Walking Distance at day 30, 6 months and 12 months	30 days, 6 and 12 months