se of mechanical left ventricular unloading in acute decompensated systolic heart failure complicated by cardiogenic shock

Phase 3

• Conditions: heart failure; shock; 10019280

• Registration Number: NL-OMON53204
• Lead Sponsor: Amsterdam UMC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 9 April 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 154

Inclusion Criteria

1. Evidence of HFrEF according to ESC HF guidelines, (LVEF <= 35%)
2. Signs of (persistent) congestion (elevated CVP, edema, rales)
3. Evidence of CS with presence of at least 2 of the 3 following
a. hypotension (systolic blood pressure <90 mmHg or mean arterial pressure <60
mmHg)
b. oliguria (<= 0,5 ml/kg/h, <= 720 ml/24 h, lactate > 2 mmol/L,creatinine rise >=
0.3 mg/dl during first
24h ( 26,53 µmol/L, amino-L-transferase >200 U/L)
c. inotropes/vasoactive (use of)
4. Age 18-75 y

Exclusion Criteria

1. Cardiovascular
a. Contraindications for Impella CP
b. Severe concomitant RV failure
c. Contraindications for inotropic usage
d. Dialysis for end-stage renal failure
e. Acute coronary syndrome during admission
2. Medical history
a. History of CVA or TIA within previous 90 days
b. History of acute myocardial infarction within previous 30 days
c. History of bleeding diathesis
3. Inflammatory
a. Active systemic infections, sepsis
4. General
a. Patient has other medical, social, or psychological problems
b. Patient belongs to a vulnerable population

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>COMBINED CLINICAL ENDPOINT (90 days)<br /><br>All-cause mortality<br /><br>Renal replacement therapy<br /><br>Rehospitalization/urgent hospital visit for HF </p><br>