Heart FailureNCT01221116
Inotropic Treatment With Levosimendan (SimdaxR)in Heart Surgery
A study testing levosimendan in people with Heart Failure and Cardiac Surgery, run by Ullevaal University Hospital at 1 site in Norway.
Trial summary
Hypothesis: Treatment with levosimendan will preserve myocardial function and hemodynamics after cardiac surgery and lead to reduced stay at intensive care unit Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Heart Failure, Cardiac Surgery
- What is being tested?
- levosimendan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteNorway
- Study dates
- Jan 2003to Dec 2008
- Phase
- Interventional
- 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
- EF (ejection fraction)<40%
Who cannot join
- renal failure, liver failure
Trial locations and contacts
1 site in 1 country.
Norway1 site
Dept. of Cardiothoracic Anesthesia, Ullevål University Hospital
Oslo, Oslo, 0407
About this study
Hypothesis: Treatment with levosimendan will preserve myocardial function and hemodynamics after cardiac surgery and lead to reduced stay at intensive care unit
Read the detailed description
Single center, prospective, randomized parallel-group, double-blinded study
- Conditions
- Heart Failure, Cardiac Surgery
- Being tested
- levosimendan
- Keywords
- coronary artery disease,, aortic stenosis,, heart failure
- Medical subject headings
- Heart Failure, Coronary Artery Disease, Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
levosimendanDrug
Also called Type of surgery
levosimendan 0.1 microgram/kg/min) for 24 hours
| Study group | Role | What they receive |
|---|---|---|
| 1: Type of surgery | No intervention | Two types of patients are compared (placebo vs levosimendan): CABG - coronary artery bypass grafting and AVR - aortic valve replacement (either with or without CABG - coronary artery bypass grafting) Receives: Drug: levosimendan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Need for inotropic agents or IABP (intra aortal balloon pump)
Measured: jan 2003 - dec 2008
Secondary outcomes (1)
Biochemical, echocardiographic data, Gated SPECT (single photon emission gated tomography) data, laser Doppler data, 24 hour ECG (electrocardiogram) data and clinical "all round" data.
Measured: jan 2003-dec 2008
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2010 (estimated)
- Study startJan 2003
- Primary completionDec 2008
- Study completionDec 2008
Why it stopped: The study was stopped due to difficulties in including patients
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ullevaal University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Knut A Kirkebøen, MD, PhD, Principal investigator, Ullevaal University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01221116
- Sponsor's protocol ID
- INSI-study
- Status last verified
- Jan 2003
- First submitted
- 13 Oct 2010
- Last updated
- 2 Nov 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inotropic Treatment With Levosimendan (SimdaxR)in Heart Surgery
- ClinicalTrials.gov ID
- NCT01221116
- Acronym / sponsor ID
- INSI-study
- Conditions
- Heart Failure, Cardiac Surgery
- Keywords
- coronary artery disease,, aortic stenosis,, heart failure
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was stopped due to difficulties in including patients
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Ullevaal University HospitalUniversity, hospital or other
- Study start
- Jan 2003
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 14 Oct 2010 (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.
Hypothesis: Treatment with levosimendan will preserve myocardial function and hemodynamics after cardiac surgery and lead to reduced stay at intensive care unit
Detailed description
Single center, prospective, randomized parallel-group, double-blinded study
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1: Type of surgery | No intervention | Drug: levosimendanTwo types of patients are compared (placebo vs levosimendan): CABG - coronary artery bypass grafting and AVR - aortic valve replacement (either with or without CABG - coronary artery bypass grafting) |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- EF (ejection fraction)<40%
Key exclusion criteria (1 listed)
- renal failure, liver failure
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 |
|---|---|---|
| levosimendanAlso: Type of surgerylevosimendan 0.1 microgram/kg/min) for 24 hours | Drug | 1: Type of surgery |
Primary outcome
Need for inotropic agents or IABP (intra aortal balloon pump)
Time frame: jan 2003 - dec 2008
1 secondary outcome
Biochemical, echocardiographic data, Gated SPECT (single photon emission gated tomography) data, laser Doppler data, 24 hour ECG (electrocardiogram) data and clinical "all round" data.
Time frame: jan 2003-dec 2008
Results and safety
The study was stopped early (reason given: The study was stopped due to difficulties in including patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2010.
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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.
Knut A Kirkebøen, MD, PhD principal investigator
Ullevaal University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing levosimendan in people with Heart Failure and Cardiac Surgery, run by Ullevaal University Hospital at 1 site in Norway.
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 1 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: stopped early, as of the sponsor's last update on 2 Nov 2010. 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 Norway. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The study was stopped due to difficulties in including patients). Results are not available in the source record.
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?
Need for inotropic agents or IABP (intra aortal balloon pump) (time frame: jan 2003 - dec 2008). 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 2 Nov 2010.