A Pilot Study of Recombinant Human Relaxin (rhRlx) in Com... | NCT00259116

Studies
A Pilot Study of Recombinant Human Relaxin (rhRlx) in Compensated Congestive Heart Failure

NCT00259116

Sponsor

Corthera, Inc.(formerly BAS Medical, Inc.), a member of the Novartis group of companies

Status

Completed

Last Update Posted

Apr 15, 2009Estimated

Enrollment

Phase

Phase 2

Conditions

Heart Failure, Congestive

Interventions

Relaxin

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2005

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Nov 28, 2005

First Submission Date that Met QC Criteria

Nov 28, 2005

First Posted Date

Nov 29, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 13, 2009

Last Update Posted Date

Apr 15, 2009Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

Corthera, Inc.(formerly BAS Medical, Inc.), a member of the Novartis group of companiesINDUSTRY

Collaborators

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
Relaxin	Drug

Measure	Description	Time Frame
Cardiac hemodynamics including PCWP, CO/CI, SVR

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Sam Teichman, MD	BAS Medical - Sponsor	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Charite Hospital		Berlin		10117	Germany

ID	Term
D006333	Heart Failure

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Intervention Browse Module

MeSH Terms

ID	Term
D012065	Relaxin

Ancestor Terms

ID	Term
D003339	Corpus Luteum Hormones
D042341	Gonadal Hormones
D006728	Hormones
D006730	Hormones, Hormone Substitutes, and Hormone Antagonists

Browse Leaves

Not provided

Browse Branches

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