Trial · NCT04329624
Effect Levosimendan Administration on Postoperative NT-proBNP in Cardiac Risk Patients
NCT04329624, Phase 3, Completed, Medical University of Vienna
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Effect Levosimendan Administration on Postoperative NT-proBNP in Cardiac Risk Patients. Trials, record NCT04329624. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04329624
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Effect Levosimendan Administration on Postoperative NT-proBNP in Cardiac Risk Patients
- NCT number
- NCT04329624
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 230 participants, actual
- Lead sponsor
- Medical University of Vienna
- Conditions
- Cardiovascular Risk Factor
- Interventions
- Levosimendan, Placebo
- First posted
- 2020-04-01
- Last updated
- 2025-05-08
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Postoperative maximum NT-proBNP concentration | First 5 Postoperative Days | The administration of levosimendan improves LVEF and myocardial oxygen perfusion, which will be reflected in a decrease of postoperative NT-proBNP concentration.Since NT-proBNP is a strong predictor for postoperative cardiovascular complications in patients undergoing noncardiac surgery, we want to test the efficiency of levosimendan to decrease postoperative maxNT-proBNP concentrations in patients with increased cardiac risk factors undergoing moderate- to high-risk noncardiac surgery. |
| Secondary | Postoperative maximum troponin T concentration | First five postoperative days | Levosimendan improves myocardial perfusion and might therefore reduce the postoperative maximum rise in TnT |
| Secondary | Incidence of MINS (myocardial injury in non cardiac surgery) | First three postoperative days | Levosimendan decreases the incidence of MINS during the first 3 postoperative days as compared to placebo in patients with increased cardiovascular risk factors undergoing moderateto high-risk noncardiac surgery. MINS is defined as: (i) a non-high-sensitivity troponin T \>\_30ng/L2 and (ii) a high-sensitivity troponin T (hsTnT) of 20 to \<65 ng/L with an absolute change of at least 5 ng/L-this change threshold is independently associated with 30-day mortality \[hazard ratio (HR) 4.69; 95% confidence interval (CI) 3.52-6.25\]-or an hsTnT level \>\_65ng/ L. Furthermore, an absolute change of at least 5 ng/L is independently associated with 30-day mortality and will also be defined as MINS. TnT will be measured within 2 hours after surgery, on the first, second and third postoperative day. |
| Secondary | Myocardial Infarction | 30 days and 1 year after surgery | Levosimendan reduces the event rates of myocardial infarction and death during 30 days and 1 year after surgery as compared to placebo. Myocardial infarction is defined as a rise of TnT at least one value is above the 99th percentile URL and with at least one of the following: (i) symptoms of acute myocardial ischaemia; (ii) new ischaemic ECG changes; (iii) development of pathological Q waves; (iiii) imaging evidence of new loss of viable myocardium; (v) new regional wall motion abnormality in a pattern consistent with an ischemic ethiology; (vi) identification of a coronary thrombus by angiography including intracoronary imaging or autopsy. |
| Secondary | Disability | 30 days and 1 year after surgery | We evaluate the WHODAS 2.0 score before surgery on the day of consent, 30 days after surgery, and 1 year after surgery per phone call. For analyzing we use simply scoring. Each score is assigned to each of the following items - "none" (0), "mild" (1), "moderate" (2), "severe" (3), and "extreme (4). We will simply add up the scores from the items without recoding or collapsing of response categories, thus, there is no weighting of the individual items. As a result, the simple sum of the scores of the items across all domains constitutes a statistic that is sufficient to describe the degree of functional limitations. |
| Secondary | NT-proBNP Mortality | 30 days and 1 year after surgery | Perioperative NT-proBNP elevations are associated with postoperative mortality, cardiac mortality, mortality and nonfatal MI, and cardiac failure at both 30 days and 180 days or more after surgery. NT-proBNP values have been stratified to the previous published thresholds to predict mortality or MI after surgery. |
| Other | Sub-Study I: Fluid status determination | within 5 days after surgery | Bioimpedance spectroscopy to determine perioperative fluid status including: 1) over hydration and total body water |
| Other | Sub-Study II: Acute Kidney Injury | within 5 days after surgery | The number of patients developing acute kidney injury after and the number of patients requiring renal replacement therapy after surgery. |
| Other | Sub-Study III: Inflammatory Response | within 5 days after surgery | Effect of levosimendan on postoperative maximum Interleukin 6 and CRP concentrations. |
| Other | Sub-Study IV: Neurocognitive decline | within first 5 postoperative days and 1 year after surgery | Effect of levosimendan on postoperative neurocognitive decline assess using MoCA |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers7
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04329624
GET https://conductscience.org/api/trials/v1/NCT04329624/registered