NCT03989531

Brief Summary

Cardiogenic shock is a serious medical condition with high mortality and morbidity. This trial assesses safety, tolerability and efficacy of Adrecizumab on top of standard of care in patients with cardiogenic shock.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Apr 2019

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 4, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 17, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 18, 2019

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 26, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 26, 2021

Completed
Last Updated

October 8, 2021

Status Verified

October 1, 2021

Enrollment Period

2.1 years

First QC Date

June 17, 2019

Last Update Submit

October 7, 2021

Conditions

Cardiogenic ShockEndothelial Dysfunction

Keywords

Cardiogenic ShockAdrecizumabVascular integrityEndothelial dysfunction

Outcome Measures

Primary Outcomes (1)

  • Need of cardiovascular organ support within the first 30 days

    Number of days through day 30 without need for cardiovascular organ support, including vasopressors, or mechanical support (VA-ECMO, Impella)

    30 days

Secondary Outcomes (1)

  • 30-day-Mortality

    30 days

Study Arms (2)

Adrecizumab on top of standard of care

EXPERIMENTAL

8 mg/kg body weight Adrecizumab diluted in up to 100 mL saline as single dose infusion

Biological: Adrecizumab

Placebo on top of standard of care

PLACEBO COMPARATOR

100 mL saline as single dose infusion

Drug: Placebo

Interventions

AdrecizumabBIOLOGICAL

Drip infusion over 60 minutes

Adrecizumab on top of standard of care
PlaceboDRUG

Drip infusion over 60 minutes

Also known as: Saline
Placebo on top of standard of care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Hospitalization for Cardiogenic shock (at the discretion of the local investigator)
  • Cardiogenic shock is usually defined as:
  • Systolic blood pressure \< 90 mmHg \> 30 min or inotropes required to maintain pressure \> 90 mmHg during systole
  • Signs of left heart insufficiency and/ or pulmonary congestion
  • Signs of impaired organ perfusion with at least one of the following:
  • Altered mental status
  • Cold, clammy skin
  • Urine output \<30 ml/h
  • Serum lactate \>2mmol/l
  • Age above 18 years at time of screening
  • Body weight below 150 kg at time of screening
  • Females/Males who agree to comply with the applicable contraceptive requirements of the protocol

You may not qualify if:

  • Cardiogenic shock due to significant arrhythmias, which include any of the following: sustained ventricular tachycardia, bradycardia with sustained ventricular rate \<35 beats per minute, or atrial fibrillation/ flutter with sustained ventricular response of \>160 beats per minute
  • Cardiogenic shock due to left ventricular outflow obstruction, obstructive hypertrophic cardiomyopathy or severe aortic stenosis (i.e., aortic valve area \<0.8 cm2 or mean gradient \>50 mmHg on prior or current echocardiogram), and severe mitral stenosis
  • Cardiogenic shock due to mechanical cause or severe bleeding
  • Cardiogenic shock due to untreated clinically significant CAD requiring revascularization
  • Resuscitation \> 60 minutes
  • Severe pre-existing hepatic disease unrelated to cardiogenic shock
  • Severe pre-existing renal disease (dialysis) unrelated to cardiogenic shock etiology

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University of Berlin, Campus Benjamin-Franklin

Berlin, 12203, Germany

Location

University Heart Center Hamburg

Hamburg, 20246, Germany

Location

University of Ulm

Ulm, 89081, Germany

Location

Related Publications (1)

  • Karakas M, Akin I, Burdelski C, Clemmensen P, Grahn H, Jarczak D, Kessler M, Kirchhof P, Landmesser U, Lezius S, Lindner D, Mebazaa A, Nierhaus A, Ocak A, Rottbauer W, Sinning C, Skurk C, Soffker G, Westermann D, Zapf A, Zengin E, Zeller T, Kluge S. Single-dose of adrecizumab versus placebo in acute cardiogenic shock (ACCOST-HH): an investigator-initiated, randomised, double-blinded, placebo-controlled, multicentre trial. Lancet Respir Med. 2022 Mar;10(3):247-254. doi: 10.1016/S2213-2600(21)00439-2. Epub 2021 Dec 8.

    PMID: 34895483DERIVED

MeSH Terms

Conditions

Shock, Cardiogenic

Interventions

enibarcimabSodium Chloride

Condition Hierarchy (Ancestors)

Myocardial InfarctionMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisShock

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Mahir Karakas, MD, MBA

    University Heart Center Hamburg

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
PD Dr Mahir Karakas, MBA

Study Record Dates

First Submitted

June 17, 2019

First Posted

June 18, 2019

Study Start

April 4, 2019

Primary Completion

April 26, 2021

Study Completion

April 26, 2021

Last Updated

October 8, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Locations

DE(3)