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

Nara Medical University

Status and phase: Terminated; Phase 4

Conditions: Renal Failure; Heart Failure

Treatments: Drug: Standard heart failure therapy; Drug: Carperitide heart failure therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT00613964

Cardiol001

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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200 participants in 2 patient groups, including a placebo group

Standard Therapy

Placebo Comparator group

Description:

Standard heart failure therapy excluding carperitide administration

Treatment:

Drug: Standard heart failure therapy

Carperitide Therapy

Active Comparator group

Description:

Addition of carperitide administration to standard heart failure therapy

Treatment:

Drug: Carperitide heart failure therapy