NL-OMON53204
Not yet recruiting
Phase 3
se of mechanical left ventricular unloading in acute decompensated systolic heart failure complicated by cardiogenic shock - UNLOAD HF-CS
Amsterdam UMC0 sites154 target enrollmentTBD
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- heart failure
- Sponsor
- Amsterdam UMC
- Enrollment
- 154
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
- •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
Outcomes
Primary Outcomes
Not specified
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