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

NCT ID: NCT00613964

Last Updated: 2011-07-22

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-05-31
• Study Completion Date: 2013-05-31

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.

Conditions

Heart Failure; Renal Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Standard Therapy

Standard heart failure therapy excluding carperitide administration

Group Type: PLACEBO_COMPARATOR

Standard heart failure therapy

Intervention Type: DRUG

Loop diuretics, Aldosterone blockers, Beta blockers, ACE inhibitors, Angiotensin receptor blockers, Nitrates, digitalis

Carperitide Therapy

Addition of carperitide administration to standard heart failure therapy

Group Type: ACTIVE_COMPARATOR

Carperitide heart failure therapy

Intervention Type: DRUG

carperitide(alpha-human atrial natriuretic peptide, 0.025-0.05μg/kg/min)

Interventions

Carperitide heart failure therapy

carperitide(alpha-human atrial natriuretic peptide, 0.025-0.05μg/kg/min)

Intervention Type: DRUG

Standard heart failure therapy

Loop diuretics, Aldosterone blockers, Beta blockers, ACE inhibitors, Angiotensin receptor blockers, Nitrates, digitalis

Intervention Type: DRUG

Other Intervention Names

Loop-diuretics etc + HANP

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nara Medical University

OTHER

Sponsor Role: lead

Responsible Party

First Department of Internal Medicine, Nara medical university

Principal Investigators

Yoshihiko Saito, MD, PhD

Role: STUDY_CHAIR

First Department of Internal Medicine, Nara Medical University

Locations

First Department of Internal Medicine, Nara Medical University

Nara, , Japan

Countries

Japan

Other Identifiers

Cardiol001

Identifier Type: -

Identifier Source: org_study_id