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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00048425




Registration number
NCT00048425
Ethics application status
Date submitted
31/10/2002
Date registered
4/11/2002
Date last updated
15/12/2006

Titles & IDs
Public title
Evaluation of Intravenous Levosimendan Efficacy in the Short Term Treatment of Decompensated Chronic Heart Failure.
Scientific title
Randomized, Multicenter Evaluation of Intravenous Levosimendan Efficacy Versus Placebo in the Short Term Treatment of Decompensated Chronic Heart Failure: the REVIVE II Study.
Secondary ID [1] 0 0
3001069
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heart Failure, Congestive 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Levosimendan

Treatment: Drugs: Levosimendan
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
A clinical composite classification incorporating a Patient Global Assessment at 6 hours, 24 hours and Day 5, combined with clinical criteria for worsening heart failure through 5 days after the start of the study drug infusion.
Timepoint [1] 0 0

Eligibility
Key inclusion criteria
- A written informed consent must be obtained for hospitalized male or female patients
over 18 years old of age.

- The eligible patients must be diagnosed with worsening heart failure as evidenced by
dyspnea at rest, poor ejection fraction and have been treated with IV diuretics.

- It is allowable for the patients to be treated with IV inotropes and vasodilators.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
The following criteria would exclude the patient from study:

- invasive cardiac procedure (e.g. cardiac surgery, LVAD, cardioversion, cardiac
re-synchronization),

- rhythm disorders (e.g. earlier Torsades de Pointes, increased heart rate),

- severe ventricular outflow obstruction,

- angina,

- hypotension,

- uncorrected hypokalemia,

- CNS (e.g. stroke, TIA),

- respiratory (e.g. COPD, intubated patients, oral,

- intravenous or intramuscular steroids),

- renal insufficiency (e.g. increased serum creatinine, dialysis),

- hepatic impairment (e.g. significant increase in liver enzymes),

- decompensation from active infection and acute bleeding (e.g. severe anemia).

- Female patients of child bearing potential must have a negative pregnancy test and use
adequate contraceptive precautions.

- Also excluded is the use of amrinone and milrinone prior to randomization, a history
of hypersensitivity to levosimendan or any of the excipients and previous
participation in a clinical trial with any experimental treatment within the last 30
days.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/09/2002
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,TAS,VIC,WA
Recruitment hospital [1] 0 0
Canberra Hospital/Cardiology Department - Garran
Recruitment hospital [2] 0 0
Royal Prince Alfred Hospital/Department of Cardiology - Camperdown
Recruitment hospital [3] 0 0
Concord Hospital - Heart Failure Clinic/Department of Cardiology - Concord
Recruitment hospital [4] 0 0
Gosford Hospital - Gosford
Recruitment hospital [5] 0 0
Liverpool Hospital - Cardiology Research - Liverpool
Recruitment hospital [6] 0 0
Prince of Wales Hospital - Randwick
Recruitment hospital [7] 0 0
Royal North Shore Hospital - Cardiology Department - St. Leonards
Recruitment hospital [8] 0 0
St. George Hospital/Cardiology Department - Sydney
Recruitment hospital [9] 0 0
Royal Brisbane Hospital - Cardiology Department - Herston
Recruitment hospital [10] 0 0
The Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [11] 0 0
Flinders Medical Centre - Cardiac Research Department - Bedford Park
Recruitment hospital [12] 0 0
Queen Elizabeth Hospital/Cardiology Department - Woodville
Recruitment hospital [13] 0 0
Royal Hobart Hospital - Hobart
Recruitment hospital [14] 0 0
Launceston General Hospital/Cardiac Research Unit - Launceston
Recruitment hospital [15] 0 0
Box Hill Hospital - Coronary Care Unit - Box Hill
Recruitment hospital [16] 0 0
St. Vincent's Hospital - Cardiology Investigational Unit - Fitzroy
Recruitment hospital [17] 0 0
Karinia House/Geelong Hospital - Geelong
Recruitment hospital [18] 0 0
Level 2, Cardiology Department/Royal Melbourne Hospital - Parkville
Recruitment hospital [19] 0 0
Heart Research Institute/Sir Charles Gairdner Hospital - Nedlands
Recruitment postcode(s) [1] 0 0
2605 - Garran
Recruitment postcode(s) [2] 0 0
2050 - Camperdown
Recruitment postcode(s) [3] 0 0
NSW 2139 - Concord
Recruitment postcode(s) [4] 0 0
- Gosford
Recruitment postcode(s) [5] 0 0
2116 - Liverpool
Recruitment postcode(s) [6] 0 0
- Randwick
Recruitment postcode(s) [7] 0 0
- St. Leonards
Recruitment postcode(s) [8] 0 0
- Sydney
Recruitment postcode(s) [9] 0 0
QLD 4029 - Herston
Recruitment postcode(s) [10] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [11] 0 0
- Bedford Park
Recruitment postcode(s) [12] 0 0
5011 - Woodville
Recruitment postcode(s) [13] 0 0
7000 - Hobart
Recruitment postcode(s) [14] 0 0
7250 - Launceston
Recruitment postcode(s) [15] 0 0
- Box Hill
Recruitment postcode(s) [16] 0 0
- Fitzroy
Recruitment postcode(s) [17] 0 0
3220 - Geelong
Recruitment postcode(s) [18] 0 0
3050 - Parkville
Recruitment postcode(s) [19] 0 0
6009 - Nedlands
Recruitment outside Australia
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United States of America
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Alabama
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Arizona
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Arkansas
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Delaware
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Florida
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Kentucky
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Michigan
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Missouri
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Hadera
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Holon
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Jerusalem
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Nazareth
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Rehovot
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Zefat
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Zrifin

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Abbott
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Orion Corporation, Orion Pharma
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to evaluate the efficacy of a 24-hour infusion of levosimendan
compared with placebo in the treatment of decompensated chronic heart failure.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00048425
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Scott Krause
Address 0 0
Abbott
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00048425