Evaluation of a temporary pump in patients with decompensated heart failure
- Conditions
- Cardiogenic shock, heart failure
- Registration Number
- NL-OMON26259
- Lead Sponsor
- Erasmus MC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 30
Inclusion Criteria
CONGESTIVE HEART FAILURE (FIRST EPISODE (¡°DE NOVO¡±) OR WORSENING OF CHRONIC HEART FAILURE) WITH THE FOLLOWING CHARACTERISTICS:
BLOOD PRESSURESystolic <100 mm Hg
Exclusion Criteria
- Significant aortic valve regurgitation.
- Absent common femoral artery pulsation.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Delta SvO2 (T3h minus baseline T0h (=mean of two baseline measurements with interval 15 minutes)).
- Secondary Outcome Measures
Name Time Method - Cardiac power output at T=24h (absolute and change vs baseline).<br /><br>- NT-proBNP levels at T=48h (absolute and change vs baseline).<br /><br>- Negative fluid balance of at least 1L at T48h.<br /><br>- Patient Global Assessment: Dyspnea Severity Score or Visual Analogue Scale at T=48h (absolute and change vs baseline).<br /><br>- Escalation of therapy.<br /><br>- Duration of hospital stay.<br /><br>- Major adverse cardiac events (MACE, = combined endpoint of escalation of therapy, death, heart failure rehospitalization, TIA/stroke). To assess at 30 days and 3 months.<br>