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Heart FailurePhase 4NCT00219388

Efficacy and Safety of Treatment With Simdax® Versus Dobutrex® in Decompensated Heart Failure Patients.

A Phase 4 study testing Levosimendan in people with Heart Failure, run by Orion Corporation, Orion Pharma at 1 site in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to compare the effects of levosimendan with dobutamine on heart function in patients suffering of severe chronic heart failure. 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
How many people
60 participants
Where
1 siteSweden
Study dates
Nov 2002to Apr 2005
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

Main Inclusion Criteria:

  • Decompensated chronic heart failure of ischemic or non-ischemic origin, in NYHA class III to IV, despite optimised conventional treatment and who may benefit from intravenous positive inotropic agents as per the investigator's judgment.
  • Ongoing treatment with a beta-receptor blocking agent in a stable regimen for at least 3 months and at an optimal dose as per the investigator's judgment.
  • Left ventricular (LV) ejection fraction (EF) less than or similar to 35%.
  • CI < 2.5 l/min/m2.
  • Mean PCWP >15 mmHg.

Main Exclusion Criteria:

  • Significant mechanical obstruction affecting ventricular filling and/or outflow.
  • Systolic blood pressure 85 mmHg or less at screening and/or baseline.
  • Heart rate 130 bpm or greater, persistent for at least 5 minutes at screening and/or baseline.
  • Severe angina pectoris during the 6 hours before screening and/or baseline.
  • Deterioration of chronic heart failure due to an acute myocardial infarction within 5 days before screening measurements.
  • Administration of Simdax within 1 month before baseline.
  • A history of Torsades de Pointes.
  • Evidence of severe renal insufficiency (serum creatinine > 450 μmol/l or on dialysis) at screening.
  • Significant hepatic impairment or elevation of liver enzymes to 5 times the upper limit of normal range of the analysing laboratory at screening.
  • Acute bleeding or severe anaemia.
  • Heart surgery within 3 months before baseline.

Trial locations and contacts

1 site in 1 country.

Sweden1 site

  • Cardiology Department, Sahlgrenska University Hospital

    Gothenburg, 413 45

Other trials in Sweden

About this study

Official title: Efficacy and Safety of Short-term Intravenous Treatment With Simdax® Versus Dobutrex® in Decompensated Heart Failure Patients Treated With Beta-receptor Blocking Agents.

The purpose of this study is to compare the effects of levosimendan with dobutamine on heart function in patients suffering of severe chronic heart failure.

Read the detailed description

Patients with decompensate heart failure (NYHA III-IV) and in need of intravenous inotrop support and who fulfil all inclusion and no exclusion criteria will be randomised into the study in proportion 1:1. Although stratification will be done so patients treated with beta-receptor blocker carvedilol will be divided the same between the study groups.

All patients will receive infusions in parallell, one of the groups will receive active product (levosimendan or dobutamine) and the other will receive placebo (double-dummy technique).

Catheterisation for measurement of hemodynamic parameters will be performed according to routine methods at the clinic. The measurements of the hemodynamic variables will start 30 minutes before start of study drug infusion and will be finished 48 hours after start of infusion. The most important variables during the measurements is Cardiac Index (CI)and Pulmonary Capillary Wedge Pressure (PCWP).

Parallel registration will be done on ECG, blood pressure, blood frequency, central venous pressure, and lung artery pressure. Heart failure and other clinical symptoms will be registered continuously during 48 hours. Blood samples will be taken intermittent to record the blood values. Cogent rules for decreasing/increasing of the dose can be found in the study protocol, likewise rules for interruption or stoop for infusion.

Registration of side-effects will be done continuously. The recommendation for treatment for known side effects could be found in the protocol (section 5.3.4) and the protocol should be available during the study procedure.

One month after the study the patients will be followed up with a very careful examination and also of the amount of visits and reason for visits to hospital during the past 30-35 days.

Conditions
Heart Failure
Being tested
Levosimendan
Keywords
Safety, Efficacy, Levosimendan, Dobutamine, Intravenous, Invasive hemodynamics, Decompensated Heart Failure
Medical subject headings
Heart Failure

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.

  1. Compare the hemodynamic parameters Cardiac Index (CI) and Pulmonary Capillary Wedge Pressure (PCWP) from baseline to 24 hours, between the two groups.

Secondary outcomes (8)

  1. Compare the efficacy and safety between the treatment groups, with regard to:

  2. • Changes in hemodynamic parameters from baseline to 24 and 48 hours.

  3. • Change in study subject's and investigator's assessment of symptoms of heart failure at 48 hours and 1-month follow-up.

  4. • Change in New York Heart Association (NYHA) classat 48 hours and 1-month follow-up.

  5. • Ability to continue treatment with β-receptor blocking agents.

  6. • Days alive and out of hospital during the 1-month follow-up period.

  7. • Change in B-type Natriuretic Polypeptide (BNP)at 24 and 48 hours and 1-month follow-up.

  8. • Proportion of treatment discontinuations and/or need for rescue therapy due to lack of efficacy.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Sep 2005 (estimated)
  2. Study startNov 2002
  3. Study completionApr 2005

Resources

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
Double blind
Enrolment
60 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00219388
Sponsor's protocol ID
3001075
Other IDs
Sponsor: Orion Pharma
Status last verified
Sep 2005
First submitted
14 Sep 2005
Last updated
20 Mar 2017
Results posted
No

Publications

  • Follath F, Cleland JG, Just H, Papp JG, Scholz H, Peuhkurinen K, Harjola VP, Mitrovic V, Abdalla M, Sandell EP, Lehtonen L; Steering Committee and Investigators of the Levosimendan Infusion versus Dobutamine (LIDO) Study. Efficacy and safety of intravenous levosimendan compared with dobutamine in severe low-output heart failure (the LIDO study): a randomised double-blind trial. Lancet. 2002 Jul 20;360(9328):196-202. doi: 10.1016/s0140-6736(02)09455-2.

    PubMed 12133653

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Levosimendan in people with Heart Failure, run by Orion Corporation, Orion Pharma at 1 site in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

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 20 Mar 2017. 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 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. 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?

Compare the hemodynamic parameters Cardiac Index (CI) and Pulmonary Capillary Wedge Pressure (PCWP) from baseline to 24 hours, between the two groups.. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00219388, which also lists 1 linked publication.

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 20 Mar 2017.

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