Heart FailurePhase 4NCT00154115
Levosimendan in High Risk Heart Valve Surgery
A Phase 4 study testing levosimendan in people with Heart Failure, run by Kuopio University Hospital at 1 site in Finland.
Trial summary
Prospective, randomized, double blind study investigating the efficacy of levosimendan in heart failure after cardiac surgery. Study hypothesis: Levosimendan diminishes the need for adrenergic inotropic drugs and morbidity and may improve survival after heart valve surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- levosimendan
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteFinland
- Study dates
- Mar 2005to Dec 2008
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Eligible for cardiac valve or combined CABG and cardiac valve surgery:
- Clinical signs of cardiac insufficiency
Who cannot join
- Endocarditis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Levosimendan in Cardiac Failure After Heart Valve Surgery
Prospective, randomized, double blind study investigating the efficacy of levosimendan in heart failure after cardiac surgery.
Study hypothesis: Levosimendan diminishes the need for adrenergic inotropic drugs and morbidity and may improve survival after heart valve surgery.
Read the detailed description
200 patients are prospectively randomized in a double blind study investigating the efficacy of levosimendan in heart failure after cardiac surgery. Levosimendan/placebo is administered as 24 hour continuous infusion beginning after anesthesia induction. Primary endpoint being adrenergic inotrope need after cardiopulmonary bypass and secondary endpoints hospital and 6-month mortality and major organ failure.
- Conditions
- Heart Failure
- Being tested
- levosimendan, placebo
- Keywords
- heart failure, levosimendan, cardiac surgery
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
levosimendanDrug
Intravenous infusion, blus 24 mcg/kg in 30-minutes followed by 0.2 mcg/kg/min up to 24 hours
placeboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Levosimendan Receives: Drug: levosimendan |
| 2 | Placebo comparator | Not described Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart failure necessitating inotropic drug administering after heart valve surgery
Measured: Postoperative hospital period
Secondary outcomes (2)
Hospital morbidity and mortality
Measured: Postoperative hospital period
Postoperative mortality at six months
Measured: Six months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startMar 2005
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kuopio University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Pasi K Lahtinen, MD, Principal investigator, Kuopio University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00154115
- Sponsor's protocol ID
- KUH5070178
- Other IDs
- 106/2004
- Status last verified
- Jan 2009
- First submitted
- 7 Sep 2005
- Last updated
- 21 Jan 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Levosimendan in Cardiac Failure After Heart Valve Surgery
- ClinicalTrials.gov ID
- NCT00154115
- Acronym / sponsor ID
- KUH5070178
- Conditions
- Heart Failure
- Keywords
- heart failure, levosimendan, cardiac surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Kuopio University HospitalUniversity, hospital or other
- Study start
- Mar 2005
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 12 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Prospective, randomized, double blind study investigating the efficacy of levosimendan in heart failure after cardiac surgery.
Study hypothesis: Levosimendan diminishes the need for adrenergic inotropic drugs and morbidity and may improve survival after heart valve surgery.
Detailed description
200 patients are prospectively randomized in a double blind study investigating the efficacy of levosimendan in heart failure after cardiac surgery. Levosimendan/placebo is administered as 24 hour continuous infusion beginning after anesthesia induction. Primary endpoint being adrenergic inotrope need after cardiopulmonary bypass and secondary endpoints hospital and 6-month mortality and major organ failure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: levosimendanLevosimendan |
| 2 | Placebo comparator | Drug: placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Clinical signs of cardiac insufficiency
Key exclusion criteria (1 listed)
- Endocarditis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| levosimendanIntravenous infusion, blus 24 mcg/kg in 30-minutes followed by 0.2 mcg/kg/min up to 24 hours | Drug | 1 |
| placeboPlacebo | Drug | 2 |
Primary outcome
Heart failure necessitating inotropic drug administering after heart valve surgery
Time frame: Postoperative hospital period
2 secondary outcomes
Hospital morbidity and mortality
Time frame: Postoperative hospital period
Postoperative mortality at six months
Time frame: Six months postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pasi K Lahtinen, MD principal investigator
Kuopio University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing levosimendan in people with Heart Failure, run by Kuopio University Hospital at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jan 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart failure necessitating inotropic drug administering after heart valve surgery (time frame: Postoperative hospital period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2009.