Heart FailurePhase 3LeoDORNCT03437226
Repetitive Levosimendan Infusion for Patients With Advanced Chronic Heart Failure
A Phase 3 study testing Levosimendan 2.5 MG/ML in people with Heart Failure, run by Dr. Gerhard Pölzl at 1 site in Austria.
Trial summary
Repetitive levosimendan infusions for patients with advanced chronic heart failure (LeoDOR) A randomised, double-blind, placebo-controlled multicentre study with parallel group design. Mortality and rehospitalisation rates are high in the vulnerable phase following heart failure hospitalisation. 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 2.5 MG/ML
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 264 participants
- Where
- 1 siteAustria
- Study dates
- 8 Mar 2018to 31 Dec 2019
- Phase
- Phase 3
- 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
- Written, signed and dated informed consent.
- Male and female patients over 18 years of age.
- Women of childbearing potential must have a monthly negative pregnancy test and must refrain from breastfeeding. Women who are postmenopausal (1 year since last menstrual cycle), surgically sterilised or who have undergone a hysterectomy are considered not to be of childbearing potential.
- CHF diagnosed at least 6 months before screening and treated with individually optimised long-term oral treatment for the last month, unless not tolerated (e.g., ACE-inhibitor or AT II blocker, beta-blocker, mineralocorticoid receptor antagonist, angiotensin II receptor blocker neprilysin inhibitor [ARNI] and with devices [e.g., CRT/ICD], as needed).
- Left ventricular ejection fraction less than or equal to 30% as assessed by echocardiography, radionuclide ventriculography or contrast angiography within the index hospitalisation.
- Currently hospitalised for decompensated HF requiring i.v. diuretics, or i.v. vasodilators, or i.v. inotropic therapy, or their combination.
- Previous hospitalisation or visit to outpatient clinic requiring i.v. diuretics, i.v. vasodilators, or i.v. inotropic therapy, or their combination for acute decompensated HF within 12 months before the current hospitalisation.
- NT-proBNP level after recompensation of more or equal 2500 ng/L (BNP more or equal 900 ng/L) and/or NYHA class III or IV at study entry
Who cannot join
- Severe obstruction of ventricular outflow tracts such as haemodynamically significant uncorrected primary valve disease or hypertrophic cardiomyopathy or impaired ventricular filling such as restrictive cardiomyopathy.
- Predominantly right heart failure a/o severe tricuspid regurgitation
- Cardiac surgery or coronary angioplasty within 30 days before study drug initiation.
- Acute coronary syndrome within 30 days before study drug initiation.
- Patients who are scheduled for cardiac surgery or angioplasty in the next 3 months
- History of torsades de pointes
Show all 22Show fewer
- Stroke or transient ischaemic attack (TIA) within 3 months before study drug initiation
- Systolic blood pressure less than 90 mmHg at baseline
- Heart rate 120 bpm or greater at baseline
- Serum potassium less than 3.5 mmol/l before study drug initiation.
- Severe renal insufficiency (estimated glomerular filtration rate (eGFR) <30 ml/min/1.73m2)
- Anaemia (haemoglobin < 10 g/dl)
- Significant hepatic impairment at the discretion of the investigator.
- Hypersensitivity to levosimendan
- Other serious diseases limiting life expectancy considerably (e.g. end-stage cancer, end-stage lung disease)
- Participation in a clinical trial with any experimental treatment within 30 days prior to screening or previous participation in the present study
- Administration of levosimendan within 14 days prior the study drug initiation, the first study drug application has to be postponed for at least 14 days after the end of this premedication
- Suspected non-compliance
- Pregnant woman and nursing mother
- Failure to use highly-effective (Pearl Index lower than 1%) contraceptive methods.
- Person with any kind of dependency on the investigator
- Person held in an institution by legal or official order
Trial locations and contacts
1 site in 1 country.
Austria1 site, 1 recruiting
- Recruiting
Medical University Innsbruck
Innsbruck, Tyrol, 6020
Kathrin Becker, PhD, +43512900371 ext. 844, leodor@i-med.ac.at
Sabine Embache-Aichhorn, +43512900370 ext. 086, leodor@i-med.ac.at
About this study
Repetitive levosimendan infusions for patients with advanced chronic heart failure (LeoDOR) A randomised, double-blind, placebo-controlled multicentre study with parallel group design.
Mortality and rehospitalisation rates are high in the vulnerable phase following heart failure hospitalisation. Previous studies suggest that these events can be reduced by repeat infusions of levosimendan in patients with advanced heart failure.
- Conditions
- Heart Failure
- Being tested
- Levosimendan 2.5 MG/ML, Placebos
- Keywords
- Heart Failure, Levosimendan
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Levosimendan 2.5 MG/MLDrug
Also called Simdax, Orion Pharma, Espoo, Finland
Levosimendan Arm: 1 x 5 ml (1 vial) of levosimendan infusion concentrate is added to one 250 ml infusion bag of 5% glucose or 0.9% NaCl in diabetic patients.
PlacebosDrug
Also called Placebo Levosimendan infusion concentrate
Placebo Arm: 1 x 5 ml (1 vial) of placebo levosimendan infusion concentrate is added to one 250 ml infusion bag of 5% glucose or 0.9% NaCl in diabetic patients.
| Study group | Role | What they receive |
|---|---|---|
| Levosimendan Arm | Experimental | Patients receive 6 or 24 hours infusion depending on the site. Levosimendan 2.5 MG/M 6h infusion group: 0,2 μg/kg/min 7 times (day 0, 14, 28, 42, 56, 70, 84) Levosimendan 24h infusion group: 0,1 μg/kg/min 5 times (day 0, 21,42,63,84) Levosimendan Receives: Drug: Levosimendan 2.5 MG/ML |
| Placebo Arm | Placebo comparator | Patients receive 6 or 24 hours infusion depending on the site. 6h infusion group: 0,2 μg/kg/min 7 times (day 0, 14, 28, 42, 56, 70, 84) Placebo 24h infusion group: 0,1 μg/kg/min 5 times (day 0, 21,42,63,84) Placebo Receives: Drug: Placebos |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to death, high-urgent heart transplantation or ventricular assist device (VAD), time to non-fatal HF event
Time to event in days, from baseline visit (day 1) up to Follow-up 2 (day 180)
Measured: From baseline (day 1) up to Follow-up 2 (day 180)
Change in NT-proBNP
pg/ml
Measured: Change from Baseline NT-proBNP (day 1) to Follow-up 1 (day 90)
Secondary outcomes (8)
Change in functional status and symptoms via KCCQ (Combined Outcome measurement)
KCCQ (Kansas City Cardiomyopathy Questionnaire) The Kansas City Cardiomyopathy Questionnaire is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life.
Measured: From baseline (day 1) up to day 98 (FUP 1)
Change in functional status and symptoms via PGA (Combined Outcome measurement)
PGA (Patient's global assessment)
Measured: From baseline (day 1) up to day 98 (FUP 1)
Change in functional status and symptoms via EQ-5D-5L (Combined Outcome measurement)
EQ-5D-5L VAS is a standardised measure of health status developed by the EuroQol Group in order to provide a simple, generic measure of health for clinical and economic appraisal visual analogue scale
Measured: From baseline (day 1) up to day 98 (FUP 1)
cumulative number of: days alive out of hospital (Combined Outcome measurement)
Counted in days
Measured: From baseline (day 1) up to day 180 (FUP 2)
cumulative number of: non-fatal HF events (Combined Outcome measurement)
Counted in events
Measured: From baseline (day 1) up to day 180 (FUP 2)
cumulative number of: hospital admissions (Combined Outcome measurement)
counted in numbers
Measured: From baseline (day 1) up to day 180 (FUP 2)
death
Number of participants died within the defined time points
Measured: From baseline (day 1) to day 180 (FUP 2)
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
Number of participants with treatment-related adverse events as assessed by CTCAE v4.03 counted in numbers
Measured: From baseline (day 1) to day 180 (FUP 2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2018
- Study start8 Mar 2018
- Primary completion1 Apr 2019 (estimated)
- Study completion31 Dec 2019 (estimated)
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 264 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr. Gerhard Pölzl
- Sponsor type
- University, hospital or other
- Collaborators
- Orion Corporation, Orion Pharma
- Responsible party
- Sponsor-investigator, Dr. Gerhard Pölzl, Medical University Innsbruck
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03437226
- Sponsor's protocol ID
- LeoDOR2017
- Acronym
- LeoDOR
- Status last verified
- Aug 2018
- First submitted
- 9 Oct 2017
- Last updated
- 22 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Repetitive Levosimendan Infusion for Patients With Advanced Chronic Heart Failure
- ClinicalTrials.gov ID
- NCT03437226
- Acronym / sponsor ID
- LeoDOR / LeoDOR2017
- Conditions
- Heart Failure
- Keywords
- Heart Failure, Levosimendan
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 264 participants (estimated)
- Lead sponsor
- Dr. Gerhard PölzlUniversity, hospital or other
- Collaborators
- Orion Corporation, Orion Pharma
- Study start
- 8 Mar 2018 (actual)
- Primary completion
- 1 Apr 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 19 Feb 2018 (actual)
- 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.
Repetitive levosimendan infusions for patients with advanced chronic heart failure (LeoDOR) A randomised, double-blind, placebo-controlled multicentre study with parallel group design.
Mortality and rehospitalisation rates are high in the vulnerable phase following heart failure hospitalisation. Previous studies suggest that these events can be reduced by repeat infusions of levosimendan in patients with advanced heart 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 |
|---|---|---|
| Levosimendan Arm | Experimental | Drug: Levosimendan 2.5 MG/MLPatients receive 6 or 24 hours infusion depending on the site. Levosimendan 2.5 MG/M 6h infusion group: 0,2 μg/kg/min 7 times (day 0, 14, 28, 42, 56, 70, 84) Levosimendan 24h infusion group: 0,1 μg/kg/min 5 times (day 0, 21,42,63,84) Levosimendan |
| Placebo Arm | Placebo comparator | Drug: PlacebosPatients receive 6 or 24 hours infusion depending on the site. 6h infusion group: 0,2 μg/kg/min 7 times (day 0, 14, 28, 42, 56, 70, 84) Placebo 24h infusion group: 0,1 μg/kg/min 5 times (day 0, 21,42,63,84) Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Written, signed and dated informed consent.
- Male and female patients over 18 years of age.
- Women of childbearing potential must have a monthly negative pregnancy test and must refrain from breastfeeding. Women who are postmenopausal (1 year since last menstrual cycle), surgically sterilised or who have undergone a hysterectomy are considered not to be of childbearing potential.
- CHF diagnosed at least 6 months before screening and treated with individually optimised long-term oral treatment for the last month, unless not tolerated (e.g., ACE-inhibitor or AT II blocker, beta-blocker, mineralocorticoid receptor antagonist, angiotensin II receptor blocker neprilysin inhibitor [ARNI] and with devices [e.g., CRT/ICD], as needed).
- Left ventricular ejection fraction less than or equal to 30% as assessed by echocardiography, radionuclide ventriculography or contrast angiography within the index hospitalisation.
Key exclusion criteria (22 listed)
- Severe obstruction of ventricular outflow tracts such as haemodynamically significant uncorrected primary valve disease or hypertrophic cardiomyopathy or impaired ventricular filling such as restrictive cardiomyopathy.
- Predominantly right heart failure a/o severe tricuspid regurgitation
- Cardiac surgery or coronary angioplasty within 30 days before study drug initiation.
- Acute coronary syndrome within 30 days before study drug initiation.
- Patients who are scheduled for cardiac surgery or angioplasty in the next 3 months
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 |
|---|---|---|
| Levosimendan 2.5 MG/MLAlso: Simdax, Orion Pharma, Espoo, FinlandLevosimendan Arm: 1 x 5 ml (1 vial) of levosimendan infusion concentrate is added to one 250 ml infusion bag of 5% glucose or 0.9% NaCl in diabetic patients. | Drug | Levosimendan Arm |
| PlacebosAlso: Placebo Levosimendan infusion concentratePlacebo Arm: 1 x 5 ml (1 vial) of placebo levosimendan infusion concentrate is added to one 250 ml infusion bag of 5% glucose or 0.9% NaCl in diabetic patients. | Drug | Placebo Arm |
Primary outcome
Time to death, high-urgent heart transplantation or ventricular assist device (VAD), time to non-fatal HF event
Time frame: From baseline (day 1) up to Follow-up 2 (day 180)
Time to event in days, from baseline visit (day 1) up to Follow-up 2 (day 180)
Change in NT-proBNP
Time frame: Change from Baseline NT-proBNP (day 1) to Follow-up 1 (day 90)
pg/ml
8 secondary outcomes
Change in functional status and symptoms via KCCQ (Combined Outcome measurement)
Time frame: From baseline (day 1) up to day 98 (FUP 1)
Change in functional status and symptoms via PGA (Combined Outcome measurement)
Time frame: From baseline (day 1) up to day 98 (FUP 1)
Change in functional status and symptoms via EQ-5D-5L (Combined Outcome measurement)
Time frame: From baseline (day 1) up to day 98 (FUP 1)
cumulative number of: days alive out of hospital (Combined Outcome measurement)
Time frame: From baseline (day 1) up to day 180 (FUP 2)
cumulative number of: non-fatal HF events (Combined Outcome measurement)
Time frame: From baseline (day 1) up to day 180 (FUP 2)
cumulative number of: hospital admissions (Combined Outcome measurement)
Time frame: From baseline (day 1) up to day 180 (FUP 2)
death
Time frame: From baseline (day 1) to day 180 (FUP 2)
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
Time frame: From baseline (day 1) to day 180 (FUP 2)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2018.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Levosimendan 2.5 MG/ML in people with Heart Failure, run by Dr. Gerhard Pölzl at 1 site in Austria.
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 8 inclusion and 22 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: status not confirmed, as of the sponsor's last update on 22 Aug 2018. 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 Austria. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kathrin Becker, PhD. (+43512900371 ext. 844, leodor@i-med.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to death, high-urgent heart transplantation or ventricular assist device (VAD), time to non-fatal HF event (time frame: From baseline (day 1) up to Follow-up 2 (day 180)). 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 22 Aug 2018.