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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

About this trial

This is an interventional treatment trial for Heart Failure, Congestive focused on measuring Congestive heart failure, Relaxin, Cardiac hemodynamics

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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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

Eligibility Criteria

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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