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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
11
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.
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
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
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