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

Phase 4

Terminated

• Conditions: Heart Failure; Renal Failure
• Interventions: Drug: Standard heart failure therapy; Drug: Carperitide heart failure therapy

• Registration Number: NCT00613964
• Lead Sponsor: Nara Medical University

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 available

Study Timeline

• Study First Submitted: 2008-01-31
• Study First Submitted QC: 2008-01-31
• Study First Posted: 2008-02-13
• Status Verified: 2009-02
• Study Start: 2009-05
• Last Update Submitted: 2011-07-20
• Last Update Posted: 2011-07-22
• Primary Completion: 2013-05
• Study Completion: 2013-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard Therapy	Standard heart failure therapy	Standard heart failure therapy excluding carperitide administration
Carperitide Therapy	Carperitide heart failure therapy	Addition of carperitide administration to standard heart failure therapy

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

First Department of Internal Medicine, Nara Medical University; 🇯🇵 Nara, Japan