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

Primary Purpose

Heart Failure, Renal Failure

Status
Terminated
Phase
Phase 4
Locations
Japan
Study Type
Interventional
Intervention
Carperitide heart failure therapy
Standard heart failure therapy
Sponsored by
Nara Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure focused on measuring Natriuretic Peptides, Heart Failure, Renal Failure

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Heart failure of any etiology, diagnosed according to Framingham criteria
  • Estimated GFR </= 60 ml/min/1.73 m2)

Exclusion Criteria:

  • Severe heart failure required percutaneous cardiopulmonary bypass support (PCPS)
  • End-stage renal failure on maintenance dialysis
  • Severe hepatic dysfunction
  • Severe anemia
  • Allergic history of carperitide
  • Pregnant women

Sites / Locations

  • First Department of Internal Medicine, Nara Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Standard Therapy

Carperitide Therapy

Arm Description

Standard heart failure therapy excluding carperitide administration

Addition of carperitide administration to standard heart failure therapy

Outcomes

Primary Outcome Measures

Unexpected rehospitalization for cardiovascular events, uremic symptom, initiation of maintenance dialysis, and kidney transplantation

Secondary Outcome Measures

All cause mortality
Sudden death
Cardiovascular death
Plasma B-type natriuretic peptide concentration
Estimated GFR

Full Information

First Posted
January 31, 2008
Last Updated
July 20, 2011
Sponsor
Nara Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT00613964
Brief Title
The Effects of Carperitide on Short and Long-term Prognosis in Patients With Both Cardiac and Renal Failure
Official Title
The Effects of Carperitide on Short and Long-term Prognosis in Patients With Both Cardiac and Renal Failure
Study Type
Interventional

2. Study Status

Record Verification Date
February 2009
Overall Recruitment Status
Terminated
Study Start Date
May 2009 (undefined)
Primary Completion Date
May 2013 (Anticipated)
Study Completion Date
May 2013 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Nara Medical University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Renal Failure
Keywords
Natriuretic Peptides, Heart Failure, Renal Failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard Therapy
Arm Type
Placebo Comparator
Arm Description
Standard heart failure therapy excluding carperitide administration
Arm Title
Carperitide Therapy
Arm Type
Active Comparator
Arm Description
Addition of carperitide administration to standard heart failure therapy
Intervention Type
Drug
Intervention Name(s)
Carperitide heart failure therapy
Other Intervention Name(s)
Loop-diuretics etc + HANP
Intervention Description
carperitide(alpha-human atrial natriuretic peptide, 0.025-0.05μg/kg/min)
Intervention Type
Drug
Intervention Name(s)
Standard heart failure therapy
Intervention Description
Loop diuretics, Aldosterone blockers, Beta blockers, ACE inhibitors, Angiotensin receptor blockers, Nitrates, digitalis
Primary Outcome Measure Information:
Title
Unexpected rehospitalization for cardiovascular events, uremic symptom, initiation of maintenance dialysis, and kidney transplantation
Time Frame
at 6 months and 2 years
Secondary Outcome Measure Information:
Title
All cause mortality
Time Frame
at discharge, 6 months, and 2 years
Title
Sudden death
Time Frame
at discharge, 6 months, and 2 years
Title
Cardiovascular death
Time Frame
at discharge, 6 months, and 2 years
Title
Plasma B-type natriuretic peptide concentration
Time Frame
at discharge, 6 months, and 2 years
Title
Estimated GFR
Time Frame
at discharge, 6 months, and 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Heart failure of any etiology, diagnosed according to Framingham criteria Estimated GFR </= 60 ml/min/1.73 m2) Exclusion Criteria: Severe heart failure required percutaneous cardiopulmonary bypass support (PCPS) End-stage renal failure on maintenance dialysis Severe hepatic dysfunction Severe anemia Allergic history of carperitide Pregnant women
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yoshihiko Saito, MD, PhD
Organizational Affiliation
First Department of Internal Medicine, Nara Medical University
Official's Role
Study Chair
Facility Information:
Facility Name
First Department of Internal Medicine, Nara Medical University
City
Nara
ZIP/Postal Code
634-8522
Country
Japan

12. IPD Sharing Statement

Learn more about this trial

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

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