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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Participants receive diluent via continuous IV infusion for 48 hours. |
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| Low Dose rhRlx | Experimental | 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). |
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| High Dose rhRlx | Experimental | 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Placebo was the diluent used for preparation of the 100 µg/kg/day dose of active study medication. |
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| Measure | Description | Time Frame |
|---|---|---|
| Cardiac hemodynamics | Baseline through 27 hours post-infusion or discharge from the hospital. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline through Day 10 |
| Safety and Tolerability assessed by number of patients with adverse events (AEs) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas Dschietzig, MD | Charite Hospital, Berlin, Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Russian Scientific Centre of Surgery n.a. B.V.Petrovsky of Russian Academy of Medical Sciences | Moscow | 119992 | Russia | |||
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C577649 | serelaxin protein, human |
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| Recombinant human relaxin (rhRlx) | Drug | Recombinant human relaxin (rhRlx) diluted for continuous IV infusion. |
|
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| Baseline through Day 30 |
| Educational Scientific Medical Center of the General Management Department of the President of Russian Federation. City Clinical Hospital №51 |
| Moscow |
| 121309 |
| Russia |