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

NCT00613964 | Terminated Phase 4 DMC

• 1 other identifier: Cardiol001
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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

Keywords

Natriuretic Peptides; Heart Failure; Renal Failure

Outcome Measures

Primary Outcomes (1)

• Unexpected rehospitalization for cardiovascular events, uremic symptom, initiation of maintenance dialysis, and kidney transplantation

  at 6 months and 2 years

Secondary Outcomes (5)

• 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

Study Arms (2)

Standard Therapy

PLACEBO COMPARATOR

Standard heart failure therapy excluding carperitide administration

Drug: Standard heart failure therapy

Carperitide Therapy

ACTIVE COMPARATOR

Addition of carperitide administration to standard heart failure therapy

Drug: Carperitide heart failure therapy

Interventions

Carperitide heart failure therapy DRUG

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

Also known as: Loop-diuretics etc + HANP

Carperitide Therapy

Standard heart failure therapy DRUG

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

Standard Therapy

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Heart failure of any etiology, diagnosed according to Framingham criteria
• Estimated GFR \</= 60 ml/min/1.73 m2)

You may not qualify if:

• 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

Sponsors & Collaborators

• Nara Medical University: lead

Study Sites (1)

First Department of Internal Medicine, Nara Medical University

Nara, 634-8522, Japan

Location

MeSH Terms

Conditions

Heart Failure; Renal Insufficiency

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Yoshihiko Saito, MD, PhD

  First Department of Internal Medicine, Nara Medical University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 31, 2008
• First Posted: February 13, 2008
• Study Start: May 1, 2009
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: July 22, 2011

Record last verified: 2009-02

Locations

JP (1)