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Clinical trial No longer in our active list Phase 4 Interventional Ages 65 to 85

Effects of Levosimendan on Heart Function After TAVR in Heart Failure Patients

Official title: Regulation of Cardiac Function After TAVR in Patients With Severe Aortic Stenosis Combined With Cardiac Insufficiency: a Prospective, Single-center, Randomized Controlled Study

Run by Qilu Hospital of Shandong University · NCT06196177 · Data updated 2026-05-14

This study is no longer in our active list. It may have stopped recruiting or finished. The details below are as of 2026-05-14 and are kept for reference. Check ClinicalTrials.gov for its current status, or see similar studies below.

This study is testing if the drug levosimendan can help improve heart function in patients with severe aortic stenosis and heart failure after they have a TAVR procedure.

More Heart Failure trials

Quick facts

PhasePhase 4
Study typeInterventional
Ages65 Years to 85 Years
SexAll
Enrollment112 (estimated)
SponsorQilu Hospital of Shandong University
Academic / other
Locations1 site (Jinan, 山东省)
Trial IDNCT06196177 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are males and females aged 65-85 years with severe aortic valve stenosis and reduced left ventricular ejection fraction undergoing TAVR.

Probably not a fit

Patients with severe hepatic or renal impairment, significant hypotension, or other serious comorbidities may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the impact of levosimendan, a positive inotropic drug, on cardiac function in patients with severe aortic stenosis and heart failure following transcatheter aortic valve replacement (TAVR). A total of 112 patients will be recruited and randomly assigned to receive either levosimendan or a control treatment after their TAVR procedure. The study will monitor various cardiac parameters, including blood pressure, echocardiography results, and biomarkers, at multiple time points post-surgery. The goal is to assess the efficacy of levosimendan in improving heart function and reducing cardiovascular events in this high-risk population.

Why it matters

Potential benefit: If successful, this treatment could significantly improve heart function and outcomes for patients with severe aortic stenosis and heart failure.

How similar studies have gone: Previous studies have shown promising results with levosimendan in various cardiac settings, suggesting potential for success in this novel application.

Who can join: the full rules

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* 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 Criteria:

* 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.

Where it's running

  • QIlu hospital of shandong university
    Jinan, 山东省, China     Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Heart Failure 1020Aortic Stenosis, Severe 5Qilu Hospital of Shandong University 72
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.