Heart FailurePhase 4PELSNCT01022983
Preoperative Levosimendan and Heart Failure
A Phase 4 study testing Levosimendan in people with Heart Failure and Hip Fracture, run by Sykehuset i Vestfold HF at 4 sites in 2 countries.
Trial summary
The purpose of this study is to investigate the safety and efficacy of Levosimendan given preoperative to patients with heart failure undergoing noncardiac surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Hip Fracture
- 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
- 0 participants
- Where
- 4 sitesin 2 countries
- Study dates
- Apr 2011to Dec 2012
- 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
- Acute surgery. Hip Fracture
- Patient with cardiac failure (EF < 35%) or known coronary disease
- At least 2 of 11 comorbidities
- Patient has to use at least one heart failure medication
- Symptoms of heart failure
- NT-proBNP > 2000pg/ml
Who cannot join
- < 18 years old
- Participants in other pharmacological study
- Abuse of medicaments or alcohol
- Pregnant or breastfeeding women
- AMI at admission
- HOCM
Show all 19Show fewer
- Serious aortic stenosis (< 1 cm2)
- Sustained ventricular tachycardia
- Earlier episodes of "torsades de pointes"
- Sustained heartbeat > 120/minute
- Systolic BP < 90 mmHg
- Surgery planned not before 2 hours of study medication can be infused preoperative
- Cardiac surgery
- Dementia
- S-K < 3 mmol/l
- Allergy levosimendan
- Serious liver failure (Known Class C Child-Pugh score)
- Serious kidney failure (GFR < 30 ml/min.)
- Prolonged QTc-interval (male QTc > 0,43 s, female QTc > 0,45 s)
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
Norway2 sites
Oslo University Hospital - Ullevål
Oslo
Vestfold Hospital Trust
Tønsberg, 3103
Sweden2 sites
Mölndal Hospital
Gothenburg
Universitety Hospital Örebro
Hudiksvall
About this study
Official title: Preoperative Levosimendan in Patients With Heart Failure Undergoing Elective Noncardiac Surgery: A Randomized, Placebocontrolled Trial. SIMPLE Study
The purpose of this study is to investigate the safety and efficacy of Levosimendan given preoperative to patients with heart failure undergoing noncardiac surgery.
- Conditions
- Heart Failure, Hip Fracture
- Being tested
- Levosimendan, Placebo
- Medical subject headings
- Heart Failure, Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LevosimendanDrug
Also called Simdax, ATC-nr.: C01C X08
At least 2 hours before surgery: Infusion of Levosimendan (0,1 microgram/kg/min.). 24 hours of infusion without a bolus.
PlaceboDrug
ml/kg/hours - same infusion rate as active comparator
| Study group | Role | What they receive |
|---|---|---|
| Levosimendan | Active comparator | Not described Receives: Drug: Levosimendan |
| Povidon, waterfree etanol, glucosis 5% | Placebo comparator | Not described Receives: Drug: Levosimendan; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heartfailure - Highest NT-proBNP-value the first 7 days after surgery
Measured: NT-proBNP 6 hours postoperative, 24 hours postoperative, 48 h postoperative, 72 h postoperative, 96 h postoperative, 120 h postoperative, 144 h postoperative and 168 h postoperative
Secondary outcomes (5)
Days of hospitalization
Measured: Hospital stay - number of days patients are hospitalized
Use of inotropes (dopamine, Norepinephrine)during postoperative unit stay. Mg/microgram
Measured: After 16-18 hours, after 48 hours and every 24 hours if still in the PO-Unit
Mortality
Visits or patients record
Measured: 30 days
Ischemia
Continous ECG first 24 hours an ECG every second day
Measured: 7 days postoperative
Myocardial necrosis
Troponin taken every day postoperative
Measured: 7 days postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2009 (estimated)
- Study startApr 2011
- Primary completionDec 2012
- Study completionDec 2012
Why it stopped: Not finding patients for including
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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sykehuset i Vestfold HF
- Sponsor type
- University, hospital or other
- Collaborators
- Orion Corporation, Orion Pharma
- Responsible party
- Principal investigator, Espen Lindholm, Sykehuset i Vestfold HF
- Investigators
- Espen Lindholm, MD, Study director, Vestfold Hospital trust, NorwayKnut A Kirkebøen, PhD, Principal investigator, Oslo University Hospital - Ullevål, NorwayMathias Kotyra, Md, Principal investigator, Mölndal hospital, SwedenAnders Nydahl, Phd, Principal investigator, University Hospital Örebro, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01022983
- Sponsor's protocol ID
- SIMPLE
- Acronym
- PELS
- Status last verified
- Dec 2012
- First submitted
- 24 Nov 2009
- Last updated
- 17 Dec 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Levosimendan in Patients With Heart Failure Undergoing Elective Noncardiac Surgery: A Randomized, Placebocontrolled Trial. SIMPLE Study
- ClinicalTrials.gov ID
- NCT01022983
- Acronym / sponsor ID
- PELS / SIMPLE
- Conditions
- Heart Failure, Hip Fracture
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Not finding patients for including
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Sykehuset i Vestfold HFUniversity, hospital or other
- Collaborators
- Orion Corporation, Orion Pharma
- Study start
- Apr 2011
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 1 Dec 2009 (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.
The purpose of this study is to investigate the safety and efficacy of Levosimendan given preoperative to patients with heart failure undergoing noncardiac surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Levosimendan | Active comparator | Drug: Levosimendan |
| Povidon, waterfree etanol, glucosis 5% | Placebo comparator | Drug: Levosimendan, Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Acute surgery. Hip Fracture
- Patient with cardiac failure (EF < 35%) or known coronary disease
- At least 2 of 11 comorbidities
- Patient has to use at least one heart failure medication
- Symptoms of heart failure
Key exclusion criteria (19 listed)
- < 18 years old
- Participants in other pharmacological study
- Abuse of medicaments or alcohol
- Pregnant or breastfeeding women
- AMI at admission
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: Simdax, ATC-nr.: C01C X08At least 2 hours before surgery: Infusion of Levosimendan (0,1 microgram/kg/min.). 24 hours of infusion without a bolus. | Drug | Levosimendan, Povidon, waterfree etanol, glucosis 5% |
| Placeboml/kg/hours - same infusion rate as active comparator | Drug | Povidon, waterfree etanol, glucosis 5% |
Primary outcome
Heartfailure - Highest NT-proBNP-value the first 7 days after surgery
Time frame: NT-proBNP 6 hours postoperative, 24 hours postoperative, 48 h postoperative, 72 h postoperative, 96 h postoperative, 120 h postoperative, 144 h postoperative and 168 h postoperative
5 secondary outcomes
Days of hospitalization
Time frame: Hospital stay - number of days patients are hospitalized
Use of inotropes (dopamine, Norepinephrine)during postoperative unit stay. Mg/microgram
Time frame: After 16-18 hours, after 48 hours and every 24 hours if still in the PO-Unit
Mortality
Time frame: 30 days
Ischemia
Time frame: 7 days postoperative
Myocardial necrosis
Time frame: 7 days postoperative
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2012.
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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.
Espen Lindholm, MD study director
Vestfold Hospital trust, Norway
Knut A Kirkebøen, PhD principal investigator
Oslo University Hospital - Ullevål, Norway
Mathias Kotyra, Md principal investigator
Mölndal hospital, Sweden
4 sites in 2 countries: 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 and Hip Fracture, run by Sykehuset i Vestfold HF at 4 sites in 2 countries.
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 6 inclusion and 19 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: withdrawn, as of the sponsor's last update on 17 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Norway, Sweden. 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 was withdrawn before enrolling participants, so there are no results.
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?
Heartfailure - Highest NT-proBNP-value the first 7 days after surgery (time frame: NT-proBNP 6 hours postoperative, 24 hours postoperative, 48 h postoperative, 72 h postoperative, 96 h postoperative, 120 h postoperative, 144 h postoperative and 168 h postoperative). 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 17 Dec 2012.