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Acute Heart FailurePhase 3NCT00348504

Survival of Patients With Acute Heart Failure in Need of Intravenous Inotropic Support: a Multicentre, Parallel-Group, Randomised, Double-Blind, Double-Dummy Study of Levosimendan Versus Dobutamine in Patients With Acute Heart Failure.

A Phase 3 study testing levosimendan and dobutamine in people with Acute Heart Failure, run by Abbott at 1 site in United States.

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 primary objective of the study is to compare the efficacy of levosimendan and dobutamine on all-cause mortality in the 180 days following randomization. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Acute Heart Failure
What is being tested?
levosimendan and dobutamine
How many people
1,300 participants
Where
1 siteUnited States
Study dates
Mar 2003to Jun 2005
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. Females of childbearing potential must have a negative pregnancy test and must refrain from breastfeeding. Women who are postmenopausal [two years since last menstrual cycle], surgically sterilised or who have undergone a hysterectomy are considered not to be of childbearing potential
  • Hospitalised patients with acutely decompensated heart failure
  • Left ventricular ejection fraction less than or equal to 30 % as assessed using echocardiography, radionuclide ventriculography or contrast angiography within 12 months
  • Clinical need for intravenous inotropic support as evidenced by insufficient response to intravenous diuretics and/or vasodilators (nitroglycerin, nitroprusside) and at least one of the following at screening:
  • oliguria (mean urine output < 30 ml/h for at least 6 hours) and not a result of hypovolemia
  • dyspnoea at rest or mechanical ventilation for heart failure
  • haemodynamic impairment in those patients with Swan-Ganz catheter inserted (PCWP ≥ 18 mmHg and/or Cardiac Index ≤ 2.2 l/min/m2)

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
  • Weight ≥ 160 kg
  • Cardiac surgery within 30 days before screening
  • Stroke within 3 months before screening
  • Systolic blood pressure persistently less than 85 mmHg at screening or at baseline
  • Heart rate persistently 130 bpm or greater at screening or at baseline
Show all 18Show fewer
  • Serum potassium less than 3.5 mmol/l at screening
  • Administration of any inotropic agent (e.g. dobutamine, milrinone, amrinone, enoximone, epinephrine, norepinephrine) except digitalis or dopamine (with dose of less than or equal than 2 mg/kg/min) during the current hospitalisation
  • Hypersensitivity to levosimendan or dobutamine or any of their excipients
  • A history of Torsades de Pointes
  • Severe renal insufficiency (serum creatinine > 450 mmol/l [5.0 mg/dl]) or on dialysis
  • Significant hepatic impairment at discretion of the investigator
  • Acute bleeding
  • Severe anemia (haemoglobin < 8 g/dl) at screening
  • Septicaemia or septic shock
  • Other serious diseases limiting life expectancy considerably (e.g. end-stage cancer)
  • 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 30 days prior to screening

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Global Medical Information - Abbott

    Abbott Park, Illinois, 60064

Other trials in United States

About this study

The primary objective of the study is to compare the efficacy of levosimendan and dobutamine on all-cause mortality in the 180 days following randomization.

Being tested
levosimendan, dobutamine

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • levosimendanDrug

  • dobutamineDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. All-cause mortality in the 180 days following randomization.

Secondary outcomes (6)

  1. All-cause mortality during the 31 days following randomization

  2. Mean change in plasma BNP concentration from baseline to 24 hours after the start of the study drug infusion

  3. Number of day alive and out of hospital (DAOH) during the 180 days following randomization

  4. Patient's evaluation of change in dyspnea at 24 hours following randomization

  5. Patient's evaluation of change in Global Assessment at 24 hours following randomization

  6. Cardiovascular mortality during the 180 days following randomization

Timeline

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

  1. First posted4 Jul 2006 (estimated)
  2. Study startMar 2003
  3. Study completionJun 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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Enrolment
1,300 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00348504
Sponsor's protocol ID
3001077
Status last verified
Nov 2007
First submitted
30 Jun 2006
Last updated
20 Nov 2007
Results posted
No

Publications

  • Cohen-Solal A, Logeart D, Huang B, Cai D, Nieminen MS, Mebazaa A. Lowered B-type natriuretic peptide in response to levosimendan or dobutamine treatment is associated with improved survival in patients with severe acutely decompensated heart failure. J Am Coll Cardiol. 2009 Jun 23;53(25):2343-8. doi: 10.1016/j.jacc.2009.02.058.

    PubMed 19539144

  • Mebazaa A, Nieminen MS, Packer M, Cohen-Solal A, Kleber FX, Pocock SJ, Thakkar R, Padley RJ, Poder P, Kivikko M; SURVIVE Investigators. Levosimendan vs dobutamine for patients with acute decompensated heart failure: the SURVIVE Randomized Trial. JAMA. 2007 May 2;297(17):1883-91. doi: 10.1001/jama.297.17.1883.

    PubMed 17473298

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing levosimendan and dobutamine in people with Acute Heart Failure, run by Abbott at 1 site in United States.

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 18 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 20 Nov 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 United States. 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 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?

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?

All-cause mortality in the 180 days following randomization.. 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 NCT00348504, which also lists 2 linked publications.

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 Nov 2007.

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