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

July 20, 2011 updated by: Nara Medical University
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Nara, Japan, 634-8522
        • First Department of Internal Medicine, Nara Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Standard Therapy
Standard heart failure therapy excluding carperitide administration
Drug: Standard heart failure therapy
Loop diuretics, Aldosterone blockers, Beta blockers, ACE inhibitors, Angiotensin receptor blockers, Nitrates, digitalis
Active Comparator: Carperitide Therapy
Addition of carperitide administration to standard heart failure therapy
Drug: Carperitide heart failure therapy
carperitide(alpha-human atrial natriuretic peptide, 0.025-0.05μg/kg/min)
Other Names:
  • Loop-diuretics etc + HANP

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
All cause mortality
Time Frame: at discharge, 6 months, and 2 years
at discharge, 6 months, and 2 years
Sudden death
Time Frame: at discharge, 6 months, and 2 years
at discharge, 6 months, and 2 years
Cardiovascular death
Time Frame: at discharge, 6 months, and 2 years
at discharge, 6 months, and 2 years
Plasma B-type natriuretic peptide concentration
Time Frame: at discharge, 6 months, and 2 years
at discharge, 6 months, and 2 years
Estimated GFR
Time Frame: at discharge, 6 months, and 2 years
at discharge, 6 months, and 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nara Medical University

Investigators

  • Study Chair: Yoshihiko Saito, MD, PhD, First Department of Internal Medicine, Nara Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2009

Primary Completion (Anticipated)

May 1, 2013

Study Completion (Anticipated)

May 1, 2013

Study Registration Dates

First Submitted

January 31, 2008

First Submitted That Met QC Criteria

January 31, 2008

First Posted (Estimate)

February 13, 2008

Study Record Updates

Last Update Posted (Estimate)

July 22, 2011

Last Update Submitted That Met QC Criteria

July 20, 2011

Last Verified

February 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Cardiol001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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