Chronic Heart FailurePhase 2NCT00130884
Peroral Levosimendan in Chronic Heart Failure
A Phase 2 study testing levosimendan in people with Chronic Heart Failure and Heart Diseases, run by Orion Corporation, Orion Pharma at 1 site in Finland.
Trial summary
The study will investigate the efficacy of oral levosimendan in patients with chronic New York Heart Association (NYHA) IIIb-IV heart failure (HF) using a composite end-point evaluating patient symptoms, morbidity and mortality. The patients are on treatment for at least 6 months. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Heart Failure, Heart Diseases
- What is being tested?
- levosimendan
- How many people
- 300 participants
- Where
- 1 siteFinland
- Study dates
- Mar 2005to Mar 2006
- Phase
- Phase 2
- 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
- Diagnosed chronic heart failure
- Severe symptoms (NYHA IIIb-IV)
- Optimal on-going oral treatment for HF
- Left ventricular ejection fraction less than or equal to 30%
Who cannot join
- Severe obstruction of ventricular outflow tracts
- Acute myocardial infarction within 30 days before screening
- Cardiac surgery or coronary angioplasty within 30 days before screening
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Peroral Levosimendan in the Prevention of Further Hospitalisations in Patients With Chronic Heart Failure. A Randomised, Phase II, Double-Blind, Placebo-Controlled, Multi-Centre, Parallel-Group Study
The study will investigate the efficacy of oral levosimendan in patients with chronic New York Heart Association (NYHA) IIIb-IV heart failure (HF) using a composite end-point evaluating patient symptoms, morbidity and mortality. The patients are on treatment for at least 6 months.
Read the detailed description
The patients are randomised to 3 groups; higher or lower levosimendan dose group or placebo.
- Conditions
- Chronic Heart Failure, Heart Diseases
- Being tested
- levosimendan
- Keywords
- levosimendan, chronic heart failure, oral administration
- Medical subject headings
- Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
levosimendanDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite endpoint measuring symptoms, morbidity, mortality
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2005 (estimated)
- Study startMar 2005
- Study completionMar 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 300 participants
Sponsor and investigators
- Lead sponsor
- Orion Corporation, Orion Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Markku S Nieminen, MD, Principal investigator, Helsinki University Central Hospital, Finland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00130884
- Sponsor's protocol ID
- 3001081
- Status last verified
- Feb 2007
- First submitted
- 15 Aug 2005
- Last updated
- 21 Feb 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Peroral Levosimendan in the Prevention of Further Hospitalisations in Patients With Chronic Heart Failure. A Randomised, Phase II, Double-Blind, Placebo-Controlled, Multi-Centre, Parallel-Group Study
- ClinicalTrials.gov ID
- NCT00130884
- Acronym / sponsor ID
- 3001081
- Conditions
- Chronic Heart Failure, Heart Diseases
- Keywords
- levosimendan, chronic heart failure, oral administration
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants
- Lead sponsor
- Orion Corporation, Orion PharmaIndustry (pharma, biotech, devices)
- Study start
- Mar 2005
- Study completion
- Mar 2006
- First posted
- 16 Aug 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.
The study will investigate the efficacy of oral levosimendan in patients with chronic New York Heart Association (NYHA) IIIb-IV heart failure (HF) using a composite end-point evaluating patient symptoms, morbidity and mortality. The patients are on treatment for at least 6 months.
Detailed description
The patients are randomised to 3 groups; higher or lower levosimendan dose group or placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosed chronic heart failure
- Severe symptoms (NYHA IIIb-IV)
- Optimal on-going oral treatment for HF
- Left ventricular ejection fraction less than or equal to 30%
Key exclusion criteria (3 listed)
- Severe obstruction of ventricular outflow tracts
- Acute myocardial infarction within 30 days before screening
- Cardiac surgery or coronary angioplasty within 30 days before screening
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 | Drug | – |
Primary outcome
Composite endpoint measuring symptoms, morbidity, mortality
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 Feb 2007.
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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.
Markku S Nieminen, MD principal investigator
Helsinki University Central Hospital, Finland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing levosimendan in people with Chronic Heart Failure and Heart Diseases, run by Orion Corporation, Orion Pharma 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 4 inclusion and 3 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 Feb 2007. 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Composite endpoint measuring symptoms, morbidity, mortality. 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 Feb 2007.