Heart Failure, Congestive
Conditions
Keywords
Congestive heart failure, Relaxin, Cardiac hemodynamics
Brief summary
This trial is a single center, open-label, dose-finding study of recombinant human relaxin (rhRlx) given intravenously (IV) to patients with stable, compensated CHF.
Detailed description
Serial cohorts of patients with stable CHF will be enrolled upon meeting eligibility criteria. Dose escalation will be guided by hemodynamic response, safety and tolerability. The effects of rhRlx on hemodynamics will be assessed.
Interventions
DRUGRelaxin
Sponsors
Corthera, Inc.(formerly BAS Medical, Inc.), a member of the Novartis group of companies
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Male and female patients over the age of 18 * New York Heart Association (NYHA) Class II-III CHF * Left Ventricular Ejection Fraction (LVEF) of \< 35%
Exclusion criteria
* Acute coronary syndrome * Acute decompensated CHF * Hypotension * Recent significant arrhythmia * Recent stroke * Significant renal or hepatic impairment * Pregnancy or child-bearing potential
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cardiac hemodynamics including PCWP, CO/CI, SVR | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety and tolerability | — |
| Tolerability | — |
Countries
Germany
Outcome results
None listed