A Phase 2 interventional study of Placebo and Recombinant human relaxin (rhRlx) in Congestive Heart Failure (CHF), sponsored by Corthera, Inc.(formerly BAS Medical, Inc.), a member of the Novartis group of companies. Terminated at 2 sites in Russian Federation. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2014-05-07.
Sponsored by Corthera, Inc.(formerly BAS Medical, Inc.), a member of the Novartis group of companies · Phase 2, Interventional, and Treatment
Two doses of relaxin will be compared to placebo for the treatment of patients with decompensated CHF
Pilot clinical data suggest that recombinant human relaxin may be effective in treating patients with decompensated CHF. This study will randomize patients in blinded manner to one of two doses of intravenous relaxin or placebo. Serial evaluations will include cardiac and renal function, as well as safety and tolerability.
5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.
This study's enrollment of 11 is below the median of 72 across 3,736 interventional studies indexed under Heart Failure.
Browse Heart Failure studies →Corthera, Inc.(formerly BAS Medical, Inc.), a member of the Novartis group of companies is the lead sponsor of 5 studies on the registry; none are open to participants now.
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Participants receive diluent via continuous IV infusion for 48 hours.
Drug: Placebo
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).
Drug: Recombinant human relaxin (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).
Drug: Recombinant human relaxin (rhRlx)
Placebo was the diluent used for preparation of the 100 µg/kg/day dose of active study medication.
Also known as: Diluent
Recombinant human relaxin (rhRlx) diluted for continuous IV infusion.
Also known as: serelaxin, serelaxin (RLX030)
Cardiac hemodynamics
Time frame: Baseline through 27 hours post-infusion or discharge from the hospital.
Renal function
Renal function was to be assessed by evaluation of serum creatinine, creatinine clearance, BUN, uric acid, GFR, RBF, urine output, sodium clearance, and body weight.
Time frame: Baseline through Day 10
Safety and Tolerability assessed by number of patients with adverse events (AEs)
Time frame: Baseline through Day 30
This study is terminated, as verified in May 2014. You cannot join it, but the record below documents what was studied.
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Corthera, Inc.(formerly BAS Medical, Inc.), a member of the Novartis group of companies