NCT00259116

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2005

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

November 28, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 29, 2005

Completed
Last Updated

April 15, 2009

Status Verified

April 1, 2009

First QC Date

November 28, 2005

Last Update Submit

April 13, 2009

Conditions

Heart Failure, Congestive

Keywords

Congestive heart failureRelaxinCardiac hemodynamics

Outcome Measures

Primary Outcomes (1)

  • Cardiac hemodynamics including PCWP, CO/CI, SVR

Secondary Outcomes (2)

  • Safety and tolerability

  • Tolerability

Interventions

RelaxinDRUG

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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%

You may not qualify if:

  • Acute coronary syndrome
  • Acute decompensated CHF
  • Hypotension
  • Recent significant arrhythmia
  • Recent stroke
  • Significant renal or hepatic impairment
  • Pregnancy or child-bearing potential

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Charite Hospital

Berlin, 10117, Germany

Location

MeSH Terms

Conditions

Heart Failure

Interventions

Relaxin

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Corpus Luteum HormonesGonadal HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptide HormonesPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Sam Teichman, MD

    BAS Medical - Sponsor

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 28, 2005

First Posted

November 29, 2005

Study Start

November 1, 2005

Last Updated

April 15, 2009

Record last verified: 2009-04

Locations

DE(1)