Cardiac SurgeryPhase 4NCT01595737
Comparison of the Administration of Levosimendan and Placebo in the Preparation of Critical Patients for Heart Surgery
A Phase 4 study testing Levosimendan in people with Cardiac Surgery, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
Trial summary
This study aims to examine the efficacy of levosimendan in terms of reducing postoperative mortality and severe morbidity in patients undergoing non-emergent surgery for coronary revascularisation with or without ischaemic mitral regurgitation and who may or may not require repair or replacement of the mitral valve… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Cardiac Surgery
- 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
- 30 participants
- Where
- 1 siteSpain
- Study dates
- Feb 2011to Nov 2014
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female > 18 years and < 85 years.
- LVEF ≤ 35%
- Indication for elective surgery for coronary revascularisation, with or without mitral valve repair.
- Freely choose to participate in trial and sign an informed consent
Who cannot join
- The patient does not accept the protocol.
- Allergy (hypersensitivity) to levosimendan, any of its components or to riboflavin.
- Severe hypotension or severe tachycardia prior to entering study.
- Significant mechanical obstruction affecting ventricular filling and/or emptying.
- History of Torsades.
- Requirement for inotropic or vasoactive drugs or any type of mechanical assistance for 48 hours prior to surgery.
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- Onset of angina or acute myocardial infarction within 48 hours prior to surgery, or cardiogenic shock.
- Surgery needs that are different from those planned.
- Chronic or severe kidney failure requiring haemodialysis or peritoneal dialysis or creatinine clearance values below 30ml/min or presence of nephrotic syndrome.
- Liver failure with transaminases 4 times above the normal maximum value.
- The patient must undergo a concurrently scheduled surgery, such as for a valve other than the mitral.
- When a screening cannot be performed at least during the 24 hours before surgery.
- Uncontrolled diabetes mellitus (blood glucose > 24mmol/l or 432mg/dl).
- History of any disease over the last five years that may compromise the patient's life, other than their heart disease.
- The patient is currently abusing alcohol or toxic substances.
- Presence of any other medical or psychiatric condition that the researcher believes makes a candidate ineligible for the study.
- Women with childbearing potential who are not using an effective contraception method.
- Participation in the last 30 days in any other study with either experimental drugs or devices.
- Body Mass Index (BMI) greater than 35.
- Administration of levosimendan in the last 30 days.
Trial locations and contacts
1 site in 1 country.
About this study
This study aims to examine the efficacy of levosimendan in terms of reducing postoperative mortality and severe morbidity in patients undergoing non-emergent surgery for coronary revascularisation with or without ischaemic mitral regurgitation and who may or may not require repair or replacement of the mitral valve and have a LVEF < 35%.
- Conditions
- Cardiac Surgery
- Being tested
- Levosimendan, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LevosimendanDrug
Levosimendan perfusion for 12 hours before surgery by a single route, at a dosage of 0.1µg/kg/min without receiving the loading dose.
PlaceboDrug
Placebo group patients will receive a perfusion of 5% glucose solution. This clear solution, free of visible particles, will have 0.4mg of riboflavin sodium phosphate, 100mg of anhydrous alcohol and water for injection up to 1ml added to it. This solution will be calculated as a dose of 0.1µg/kg/min.
| Study group | Role | What they receive |
|---|---|---|
| Levosimendan | Experimental | Not described Receives: Drug: Levosimendan |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Rate of mortality
Measured: 30 days
Morbidity
Rate of morbidity
Measured: 30 days
Secondary outcomes (2)
Dose of inotropic drugs used
Requirements for inotropic drugs
Measured: 30 days
Dose of vasoactive drugs used
Requirements for vasoactive drugs
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2012 (estimated)
- Study startFeb 2011
- Primary completionNov 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac SurgeryStudies of the same condition, open and under way.
- More trials run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01595737
- Sponsor's protocol ID
- ACA-SPAI-2008-20
- Status last verified
- May 2012
- First submitted
- 7 May 2012
- Last updated
- 12 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Administration of Levosimendan and Placebo in the Preparation of Critical Patients for Heart Surgery
- ClinicalTrials.gov ID
- NCT01595737
- Acronym / sponsor ID
- ACA-SPAI-2008-20
- Conditions
- Cardiac Surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 10 May 2012 (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.
This study aims to examine the efficacy of levosimendan in terms of reducing postoperative mortality and severe morbidity in patients undergoing non-emergent surgery for coronary revascularisation with or without ischaemic mitral regurgitation and who may or may not require repair or replacement of the mitral valve and have a LVEF < 35%.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Levosimendan | Experimental | Drug: Levosimendan |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female > 18 years and < 85 years.
- LVEF ≤ 35%
- Indication for elective surgery for coronary revascularisation, with or without mitral valve repair.
- Freely choose to participate in trial and sign an informed consent
Key exclusion criteria (20 listed)
- The patient does not accept the protocol.
- Allergy (hypersensitivity) to levosimendan, any of its components or to riboflavin.
- Severe hypotension or severe tachycardia prior to entering study.
- Significant mechanical obstruction affecting ventricular filling and/or emptying.
- History of Torsades.
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 |
|---|---|---|
| LevosimendanLevosimendan perfusion for 12 hours before surgery by a single route, at a dosage of 0.1µg/kg/min without receiving the loading dose. | Drug | Levosimendan |
| PlaceboPlacebo group patients will receive a perfusion of 5% glucose solution. This clear solution, free of visible particles, will have 0.4mg of riboflavin sodium phosphate, 100mg of anhydrous alcohol and water for injection up to 1ml added to it. This solution will be calculated as a dose of 0.1µg/kg/min. | Drug | Placebo |
Primary outcome
Mortality
Time frame: 30 days
Rate of mortality
Morbidity
Time frame: 30 days
Rate of morbidity
2 secondary outcomes
Dose of inotropic drugs used
Time frame: 30 days
Dose of vasoactive drugs used
Time frame: 30 days
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 12 Mar 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Cardiac Surgery, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
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 4 inclusion and 20 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 12 Mar 2015. 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 Spain. 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?
Mortality (time frame: 30 days). The study lists 2 primary outcomes in all. 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 12 Mar 2015.