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

Primary Purpose

Cardiogenic Shock

Status
Recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Impella
VA-ECMO
Sponsored by
Universitätsklinikum Hamburg-Eppendorf
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cardiogenic Shock focused on measuring Active left ventricular unloading, VA-ECMO, Impella, Cardiogenic shock

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University Heart and Vascular Center HamburgRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Impella + VA-ECMO

VA-ECMO only

Arm Description

Outcomes

Primary Outcome Measures

Time to death from any-cause within 30 days after randomization
Time to death from any-cause within 30 days after randomization

Secondary Outcome Measures

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
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
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).
Days free from veno-arterial extracorporeal membrane oxygenation therapy in 30 days
Days free from veno-arterial extracorporeal membrane oxygenation therapy in 30 days
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
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
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
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
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
6-Minute Walking Distance at day 30, 6 months and 12 months
6-Minute Walking Distance at day 30, 6 months and 12 months

Full Information

First Posted
October 10, 2022
Last Updated
December 28, 2022
Sponsor
Universitätsklinikum Hamburg-Eppendorf
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1. Study Identification

Unique Protocol Identification Number
NCT05577195
Brief Title
Left Ventricular Unloading to Improve Outcome in Cardiogenic Shock Patients on VA-ECMO
Official Title
UNLOAD ECMO - Left Ventricular Unloading to Improve Outcome in Cardiogenic Shock Patients on VA-ECMO - a Prospective, Randomized, Controlled, Multi-center Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 17, 2022 (Actual)
Primary Completion Date
November 30, 2024 (Anticipated)
Study Completion Date
December 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universitätsklinikum Hamburg-Eppendorf

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiogenic Shock
Keywords
Active left ventricular unloading, VA-ECMO, Impella, Cardiogenic shock

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
198 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Impella + VA-ECMO
Arm Type
Experimental
Arm Title
VA-ECMO only
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Impella
Intervention Description
To provide active left ventricular unloading in the experimental arm
Intervention Type
Device
Intervention Name(s)
VA-ECMO
Intervention Description
To provide circulatory support in both arms
Primary Outcome Measure Information:
Title
Time to death from any-cause within 30 days after randomization
Description
Time to death from any-cause within 30 days after randomization
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Death from any-cause at 6 and 12 months as well as time to death at these time points
Description
Cardiovascular death at day 30, 6 months and 12 months as well as time to death at these time points
Time Frame
6 and 12 months
Title
Cardiovascular death at day 30, 6 months and 12 months as well as time to death at these time points
Description
Cardiovascular death at day 30, 6 months and 12 months as well as time to death at these time points
Time Frame
30 days, 6 and 12 months
Title
Length of veno-arterial extracorporeal membrane oxygenation therapy, mechanical ventilation, inotrope therapy and stay at the intensive care unit (in days).
Description
Length of veno-arterial extracorporeal membrane oxygenation therapy, mechanical ventilation, inotrope therapy and stay at the intensive care unit (in days).
Time Frame
12 months
Title
Days free from veno-arterial extracorporeal membrane oxygenation therapy in 30 days
Description
Days free from veno-arterial extracorporeal membrane oxygenation therapy in 30 days
Time Frame
30 days
Title
Need for renal replacement therapy until day 30, 6 months and 12 months
Description
Need for renal replacement therapy, intermittent or ongoing, until day 30, 6 months and 12 months
Time Frame
30 days, 6 and 12 months
Title
Neurological function (per Cerebral Performance Category) at day 30, 6 months and 12 months
Description
Neurological function (per Cerebral Performance Category) at day 30, 6 months and 12 months
Time Frame
30 days, 6 and 12 months
Title
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
Description
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
Time Frame
6 and 12 months
Title
Left ventricular function assessed by echocardiography at day 30, 6 months and 12 months
Description
Left ventricular function assessed by echocardiography at day 30, 6 months and 12 months
Time Frame
30 days, 6 and 12 months
Title
Quality of life as assessed by the "Kansas City Cardiomyopathy Questionnaire" at 30-days and at 12 months
Description
Quality of life as assessed by the "Kansas City Cardiomyopathy Questionnaire" at 30-days and at 12 months
Time Frame
30 days and 6 months
Title
6-Minute Walking Distance at day 30, 6 months and 12 months
Description
6-Minute Walking Distance at day 30, 6 months and 12 months
Time Frame
30 days, 6 and 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dirk Westermann, Prof.
Phone
0049 40 7410 0
Email
d.westermann@uke.de
First Name & Middle Initial & Last Name or Official Title & Degree
Benedikt Schrage, Dr.
Email
b.schrage@uke.de
Facility Information:
Facility Name
University Heart and Vascular Center Hamburg
City
Hamburg
ZIP/Postal Code
20251
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Benedikt Schrage, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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