Recombinant Human Relaxin for the Treatment of Decompensated CHF
NCT ID: NCT00406575
Last Updated: 2014-05-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
11 participants
INTERVENTIONAL
2006-11-30
2007-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Placebo
Participants receive diluent via continuous IV infusion for 48 hours.
Placebo
Placebo was the diluent used for preparation of the 100 µg/kg/day dose of active study medication.
Low Dose rhRlx
Participants receive recombinant human relaxin (rhRlx) via continuous IV infusion for 48 hours at a rate of 100 µg/kg/day (corresponding to a dose of 4.2 µg/kg/hr).
Recombinant human relaxin (rhRlx)
Recombinant human relaxin (rhRlx) diluted for continuous IV infusion.
High Dose rhRlx
Participants receive recombinant human relaxin (rhRlx) via continuous IV infusion for 48 hours at a rate of 500 µg/kg/day (corresponding to a dose of 21.0 µg/kg/hr).
Recombinant human relaxin (rhRlx)
Recombinant human relaxin (rhRlx) diluted for continuous IV infusion.
Interventions
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Placebo
Placebo was the diluent used for preparation of the 100 µg/kg/day dose of active study medication.
Recombinant human relaxin (rhRlx)
Recombinant human relaxin (rhRlx) diluted for continuous IV infusion.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Decompensated chronic CHF (NYHA Class III-IV)
* LVEF \< 35%
* PCWP \> 22 mmHg
* CI \< 2.3 L/min/m2
Exclusion Criteria
* Acute coronary syndrome
* Hypotension or shock
* Recent stroke
* Allergy or sensitivity to test agents
* Significant confounding conditions or medications
19 Years
ALL
No
Sponsors
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Corthera, Inc.(formerly BAS Medical, Inc.), a member of the Novartis group of companies
INDUSTRY
Responsible Party
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Principal Investigators
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Thomas Dschietzig, MD
Role: PRINCIPAL_INVESTIGATOR
Charite Hospital, Berlin, Germany
Locations
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Russian Scientific Centre of Surgery n.a. B.V.Petrovsky of Russian Academy of Medical Sciences
Moscow, , Russia
Educational Scientific Medical Center of the General Management Department of the President of Russian Federation. City Clinical Hospital №51
Moscow, , Russia
Countries
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Other Identifiers
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RLX.CHF.002
Identifier Type: -
Identifier Source: org_study_id
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