Status:
UNKNOWN
Effects of Levosimendan on Cardiac Function After TAVR in Patients With Heart Failure
Lead Sponsor:
Qilu Hospital of Shandong University
Conditions:
Heart Failure
Aortic Stenosis, Severe
Eligibility:
All Genders
65-85 years
Phase:
PHASE4
Brief Summary
Patients with severe aortic stenosis combined with severe heart failure often miss the opportunity for surgery, and the prognosis is poor with drug therapy alone.In recent years, the emergence of tran...
Detailed Description
We plan to recruit 112 patients with severe aortic stenosis and cardiac insufficiency, which，after TAVR, were randomly divided into treatment group (56 cases, intravenous levosimendan) and control gro...
Eligibility Criteria
Inclusion
- Male or female patients aged 65-85 years undergoing TAVR;
- Echocardiography diagnosed severe aortic valve stenosis with LVEF\<0.4；
- Prior to the initiation of the study, the patients or their legal representatives signed the informed consent form.
Exclusion
- Adverse reactions to levosimendan or other excipients;
- In addition to the aortic valve disease, still with cardiac mechanical obstructive diseases;
- Patients with severe hepatic and renal impairment (creatinine clearance \<30ml/min);
- Patients with severe hypotension (SBP\<90mmHg or DBP\<60mmHg) and ventricular tachycardia, ventricular fibrillation, and frequent premature ventricular contractions.
- Severe complications occurred during TAVR.
- Are involved in other clinical studies
- Other clinically significant respiratory, digestive, hematological, infectious, immune, endocrine, neuropsychiatric, tumor diseases, etc.
Key Trial Info
Start Date :
March 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2025
Estimated Enrollment :
112 Patients enrolled
Trial Details
Trial ID
NCT06196177
Start Date
March 1 2024
End Date
February 1 2025
Last Update
April 3 2024
Active Locations (1)
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1
QIlu hospital of shandong university
Jinan, Shandong, China, 250000