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

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00613964
• Other study ID #: Cardiol001
• Status: Terminated
• Phase: Phase 4
• First received: January 31, 2008
• Last updated: July 20, 2011
• Start date: May 2009
• Est. completion date: May 2013

Study information

• Verified date: February 2009
• Source: Nara Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 200
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Heart Failure
• Renal Failure
• Renal Insufficiency

Intervention

Drug:
• Carperitide heart failure therapy
carperitide(alpha-human atrial natriuretic peptide, 0.025-0.05µg/kg/min)
• Standard heart failure therapy
Loop diuretics, Aldosterone blockers, Beta blockers, ACE inhibitors, Angiotensin receptor blockers, Nitrates, digitalis

Locations

Country	Name	City	State
Japan	First Department of Internal Medicine, Nara Medical University	Nara

Sponsors (1)

Lead Sponsor	Collaborator
Nara Medical University

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Unexpected rehospitalization for cardiovascular events, uremic symptom, initiation of maintenance dialysis, and kidney transplantation		at 6 months and 2 years	No
Secondary	All cause mortality		at discharge, 6 months, and 2 years	No
Secondary	Sudden death		at discharge, 6 months, and 2 years	No
Secondary	Cardiovascular death		at discharge, 6 months, and 2 years	No
Secondary	Plasma B-type natriuretic peptide concentration		at discharge, 6 months, and 2 years	No
Secondary	Estimated GFR		at discharge, 6 months, and 2 years	No