The Effects of Carperitide on Short and Long-term Prognos... | NCT00613964

Studies
The Effects of Carperitide on Short and Long-term Prognosis in Patients With Both Cardiac and Renal Failure

NCT00613964

Sponsor

Nara Medical University

Status

Terminated

Last Update Posted

Jul 22, 2011Estimated

Enrollment

200Estimated

Phase

Phase 4

Conditions

Heart Failure
Renal Failure

Interventions

Carperitide heart failure therapy
Standard heart failure therapy

Countries

Japan

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

Feb 2009

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2009

Primary Completion Date

May 2013Estimated

Completion Date

May 2013Estimated

First Submitted Date

Jan 31, 2008

First Submission Date that Met QC Criteria

Jan 31, 2008

First Posted Date

Feb 13, 2008Estimated

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

Jul 20, 2011

Last Update Posted Date

Jul 22, 2011Estimated

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

Carperitide (alpha-human atrial natriuretic peptide) improves systemic hemodynamics in patients with heart failure through a vasodilatory action, a natriuretic action, and inhibition of the renin-angiotensin-aldosterone system and has been widely-used in Japan. However, a paucity of report is available on the effects of carperitide on short and long-term prognosis in patients with both cardiac and renal failure. The purpose of this study is to evaluate the effects of carperitide therapy on short and long-term prognosis in patients with both cardiac and renal failure, in comparison with standard therapy.

Detailed Description

Not provided

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 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Standard Therapy	Placebo Comparator	Standard heart failure therapy excluding carperitide administration	Drug: Standard heart failure therapy
Carperitide Therapy	Active Comparator	Addition of carperitide administration to standard heart failure therapy	Drug: Carperitide heart failure therapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Carperitide heart failure therapy	Drug	carperitide(alpha-human atrial natriuretic peptide, 0.025-0.05μg/kg/min)	Carperitide Therapy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Unexpected rehospitalization for cardiovascular events, uremic symptom, initiation of maintenance dialysis, and kidney transplantation		at 6 months and 2 years

Secondary Outcomes

Measure	Description	Time Frame
All cause mortality		at discharge, 6 months, and 2 years
Sudden death		at discharge, 6 months, and 2 years
Cardiovascular death

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Heart failure of any etiology, diagnosed according to Framingham criteria
Estimated GFR \

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Yoshihiko Saito, MD, PhD	First Department of Internal Medicine, Nara Medical University	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
First Department of Internal Medicine, Nara Medical University		Nara		634-8522	Japan

Condition Browse Module

MeSH Terms

ID	Term
D006333	Heart Failure
D051437	Renal Insufficiency

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided