Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 10:55 PM
Ignite Modification Date:
2025-12-24 @ 10:55 PM
NCT ID:
NCT01188369
Brief Summary:
This is a clinical, randomised, double-blinded study in which patients eligible for aortic valve replacement are enrolled. Patients receive infusion of either levosimendan or placebo 4 hours prior to surgery and until the end of surgery.
Detailed Description:
Levosimendan or placebo will be infusion for approximately 4 hours prior to aortic valve replacement in patients with severe hypertrophy of the left ventricle and echocardiographic signs of diastolic dysfunction. Outcome measures will be obtained at some of the following:
* Approximately 4 hours prior to surgery. Baseline. Start of levosimendan/placebo infusion
* Immediately before surgery
* After induction of anaesthesia and before "knife time" = start of surgery.
* At the end of surgery: Levosimendan infusion will stop.
* Approximately 4 hours after surgery immediately before extubation.
* Approximately 21 hours after surgery
* Approximately 96 hours after surgery (day 4)
* 6 months after surgery
Outcome measures are comprised of invasive measurements, blood samples, transthoracic echocardiography and transoesophageal echocardiography focusing on measures of systolic and diastolic function of the heart.
Interim analysis will be conducted after 30 included patients.
Study:
NCT01188369
Study Brief:
Protocol Section:
NCT01188369