Recombinant Human Relaxin for the Treatment of Decompensated CHF
A Phase II Randomized, Double Blind, Placebo-Controlled Study of Recombinant Human Relaxin in Patients With Decompensated Congestive Heart Failure
1 other identifier
interventional
11
1 country
2
Brief Summary
Two doses of relaxin will be compared to placebo for the treatment of patients with decompensated CHF
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Nov 2006
Shorter than P25 for phase_2
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2006
CompletedFirst Submitted
Initial submission to the registry
November 30, 2006
CompletedFirst Posted
Study publicly available on registry
December 4, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2007
CompletedMay 7, 2014
May 1, 2014
2 months
November 30, 2006
May 6, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Cardiac hemodynamics
Baseline through 27 hours post-infusion or discharge from the hospital.
Secondary Outcomes (2)
Renal function
Baseline through Day 10
Safety and Tolerability assessed by number of patients with adverse events (AEs)
Baseline through Day 30
Study Arms (3)
Placebo
PLACEBO COMPARATORParticipants receive diluent via continuous IV infusion for 48 hours.
Low Dose rhRlx
EXPERIMENTALParticipants 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).
High Dose rhRlx
EXPERIMENTALParticipants 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).
Interventions
Placebo was the diluent used for preparation of the 100 µg/kg/day dose of active study medication.
Recombinant human relaxin (rhRlx) diluted for continuous IV infusion.
Eligibility Criteria
You may qualify if:
- Hospitalization
- Decompensated chronic CHF (NYHA Class III-IV)
- LVEF \< 35%
- PCWP \> 22 mmHg
- CI \< 2.3 L/min/m2
You may not qualify if:
- Acute CHF
- Acute coronary syndrome
- Hypotension or shock
- Recent stroke
- Allergy or sensitivity to test agents
- Significant confounding conditions or medications
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Russian Scientific Centre of Surgery n.a. B.V.Petrovsky of Russian Academy of Medical Sciences
Moscow, 119992, Russia
Educational Scientific Medical Center of the General Management Department of the President of Russian Federation. City Clinical Hospital №51
Moscow, 121309, Russia
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Thomas Dschietzig, MD
Charite Hospital, Berlin, Germany
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 30, 2006
First Posted
December 4, 2006
Study Start
November 1, 2006
Primary Completion
January 1, 2007
Study Completion
January 1, 2007
Last Updated
May 7, 2014
Record last verified: 2014-05