Adrecizumab in Cardiogenic Shock

• Status: Completed
• Trial end date: 2021-04-26
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dr. med. Mahir Karakas

Criteria

Inclusion Criteria:

-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

Exclusion Criteria:

• 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