Trials / Unknown
UnknownNCT04573049
The Effectiveness and Safety of Levosimendan in Patients With Severe Aortic Stenosis and Heart Failure Undergoing Transcatheter Aortic Valve Replacement
A Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Effectiveness and Safety of Levosimendan in Patients With Severe Aortic Stenosis and Heart Failure Undergoing Transcatheter Aortic Valve Replacement
- Status
- Unknown
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 124 (estimated)
- Sponsor
- China National Center for Cardiovascular Diseases · Other Government
- Sex
- All
- Age
- 18 Years – 100 Years
- Healthy volunteers
- Not accepted
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
Detailed description
The number of subjects undergoing transcatheter aortic valve replacement to treat aortic stenosis have been increasing in recent decades. Levosimendan, an innovative inotrope, is powerfully evidenced to have the function to improve cardiac output and hemodynamic parameters. However, there is no specified study concentrated on the role of Levosimendan in surgical procedure such as transcathter aortic intervention. This double-blind, randomized, placebo-controlled study is aimed to investigate the effectiveness and safety of Levosimendan in adults having severe aortic stenosis combined with heart failure undergoing transcatheter aortic valve replacement. Therefore, the purpose of this trial is to explore whether the improvement of cardiac and renal performance can be rendered by intra-operative Levosimendan infusion.
Conditions
- Aortic Valve Stenosis
- Heart Failure
- Inotropic Agents
- Safety Issues
- Effect of Drug
- Cardiac Event
- Transcatheter Aortic Valve Replacement
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Levosimendan | On the basis of routine care given by corresponding clinicians, 0.1µg/kg/min levosimendan is given for 24 hours. |
| OTHER | Placebo | On the basis of routine care given by corresponding clinicians, 0.1µg/kg/min 5% glucose infusion is given for 24 hours. |
Timeline
- Start date
- 2020-09-01
- Primary completion
- 2022-04-01
- Completion
- 2022-12-30
- First posted
- 2020-10-05
- Last updated
- 2020-10-05
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT04573049. Inclusion in this directory is not an endorsement.