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

Status

Terminated

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00613964

Enrollment

200

Registered

2008-02-13

Start date

2009-05-31

Completion date

2013-05-31

Last updated

2011-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure, Renal Failure

Keywords

Natriuretic Peptides, Heart Failure, Renal Failure

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.

Interventions

DRUGCarperitide heart failure therapy

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

DRUGStandard heart failure therapy

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

20 Years to 80 Years

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
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

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026