Efficacy and Safety of Relaxin for the Treatment of Acute... | NCT00520806

Studies
Efficacy and Safety of Relaxin for the Treatment of Acute Heart Failure

NCT00520806

Sponsor

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

Status

Completed

Last Update Posted

Oct 30, 2012Estimated

Enrollment

1,161Actual

Phase

Phase 2Phase 3

Conditions

Heart Failure, Congestive

Interventions

Relaxin
Placebo

Countries

United States
Israel

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

May 2012

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

Oct 2007

Primary Completion Date

Sep 2012Actual

Completion Date

Sep 2012Actual

First Submitted Date

Aug 24, 2007

First Submission Date that Met QC Criteria

Aug 24, 2007

First Posted Date

Aug 27, 2007Estimated

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

Oct 26, 2012

Last Update Posted Date

Oct 30, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Different doses of relaxin will be compared to placebo to determine efficacy and safety for the treatment of patients hospitalized with acute heart failure

Detailed Description

This is an international, randomized, double-blind, placebo-controlled, Phase II/III trial of intravenous recombinant relaxin for the treatment of signs and symptoms in patients hospitalized for acute decompensated heart failure. The Phase II pilot study has completed; the Phase III main portion of the trial is ongoing.

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 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

1,161Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Placebo	Placebo Comparator	48 hour iv infusion of placebo	Drug: Placebo
Relaxin	Experimental	48 hour iv infusion of relaxin at 30 ug/kg/day	Drug: Relaxin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Relaxin	Drug	Intravenous infusion for 48 h at 30 ug/kg/day	Relaxin

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Relief of dyspnea in acute heart failure		Up to day 5

Secondary Outcomes

Measure	Description	Time Frame
Days alive and out of hospital		Up to day 60
CV death or rehospitalization due to heart failure or renal failure		Up to day 60

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Hospitalized for acute heart failure
Dyspnea at rest or with minimal exertion
Pulmonary congestion
Able to provide informed consent
Systolic blood pressure > 125 mmHg
Impaired renal function defined as an eGFR of 30-75 mL/min/1.73m2

Exclusion Criteria:

Use of other IV therapies for acute heart failure
Fever or sepsis
Recent major neurologic event
Recent major surgery
Recent acute coronary syndrome
Other recent investigational drug use

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Thomas Severin, MD	Novartis Pharmaceuticals	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Northwestern University		Chicago	Illinois	60611	United States
Wayne State University/Detroit Receiving Hospital

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
35184572	Derived	Grand J, Miger K, Sajadieh A, Kober L, Torp-Pedersen C, Ertl G, Lopez-Sendon J, Pietro Maggioni A, Teerlink JR, Sato N, Gimpelewicz C, Metra M, Holbro T, Nielsen OW. Blood Pressure Drops During Hospitalization for Acute Heart Failure Treated With Serelaxin: A Patient-Level Analysis of 4 Randomized Controlled Trials. Circ Heart Fail. 2022 Apr;15(4):e009199. doi: 10.1161/CIRCHEARTFAILURE.121.009199. Epub 2022 Feb 21.
34514815

ID	Term
D006333	Heart Failure
D051437	Renal Insufficiency

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D007674	Kidney Diseases
D014570	Urologic Diseases

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