A Pilot Study of Recombinant Human Relaxin (rhRlx) in Compensated Congestive Heart Failure
Primary Purpose
Heart Failure, Congestive
Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
Relaxin
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure, Congestive focused on measuring Congestive heart failure, Relaxin, Cardiac hemodynamics
Eligibility Criteria
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
Sites / Locations
- Charite Hospital
Outcomes
Primary Outcome Measures
Cardiac hemodynamics including PCWP, CO/CI, SVR
Secondary Outcome Measures
Safety and tolerability
Tolerability
Full Information
NCT ID
NCT00259116
First Posted
November 28, 2005
Last Updated
April 13, 2009
Sponsor
Corthera, Inc.(formerly BAS Medical, Inc.), a member of the Novartis group of companies
1. Study Identification
Unique Protocol Identification Number
NCT00259116
Brief Title
A Pilot Study of Recombinant Human Relaxin (rhRlx) in Compensated Congestive Heart Failure
Official Title
A Pilot Safety and Dose-Finding Trial of Intravenous Recombinant Human Relaxin (rhRlx) in Compensated Congestive Heart Failure
Study Type
Interventional
2. Study Status
Record Verification Date
April 2009
Overall Recruitment Status
Completed
Study Start Date
November 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Corthera, Inc.(formerly BAS Medical, Inc.), a member of the Novartis group of companies
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Congestive
Keywords
Congestive heart failure, Relaxin, Cardiac hemodynamics
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
18 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Relaxin
Primary Outcome Measure Information:
Title
Cardiac hemodynamics including PCWP, CO/CI, SVR
Secondary Outcome Measure Information:
Title
Safety and tolerability
Title
Tolerability
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sam Teichman, MD
Organizational Affiliation
BAS Medical - Sponsor
Official's Role
Study Director
Facility Information:
Facility Name
Charite Hospital
City
Berlin
ZIP/Postal Code
10117
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
A Pilot Study of Recombinant Human Relaxin (rhRlx) in Compensated Congestive Heart Failure
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