The Effectiveness and Safety of Levosimendan in Patients With Severe Aortic Stenosis and Heart Fa… (NCT04573049) | Clinical Trial Compass
UnknownPhase 4
The Effectiveness and Safety of Levosimendan in Patients With Severe Aortic Stenosis and Heart Failure Undergoing Transcatheter Aortic Valve Replacement
China124 participantsStarted 2020-09-01
Plain-language summary
A study to evaluate the effectiveness and safety of levosimendan compared with placebo in subjects with severe aortic stenosis and heart failure undergoing transcatheter aortic valve replacement
Who can participate
Age range18 Years – 100 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Signed (by the subjects or their legally acceptable representatives) informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study
✓. Severe aortic stenosis
✓. Mean transaortic gradient ≥ 40 mmHg(at rest or stress)
✓. Aortic peak velocity ≥ 4m/s;
✓. Arotic valve area \<0.8 cm2 and/or aortic valve area index\< 0.5cm2/m2
✓. Cardiac dysfunction
✓. LVEF≤50% (estimated by Simpson)
✓. NT-proBNP≥1500ng/L；
Exclusion criteria
✕. Decompensated acute cardiac failure due to hemodynamic instability
✕. A historty of torsade de points ventricular tachycardia
✕. Known allergic reaction or sensitivity to Levosimendan or excipients
✕. Received levosimendan within 1 week prior to the planned clinical trial
✕. Serum potassium \< 3.5 mmol/L and \> 5.5 mmol/L before the drug study
✕. Systolic blood pressure \< 90mmHg at baseline
What they're measuring
1
The change of NT-proBNP level
Timeframe: day 1, day 3, day 5, month 1 and month 3
Trial details
NCT IDNCT04573049
SponsorChina National Center for Cardiovascular Diseases