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

This study has been terminated.
Sponsor:
Information provided by:
Nara Medical University
ClinicalTrials.gov Identifier:
NCT00613964
First received: January 31, 2008
Last updated: July 20, 2011
Last verified: February 2009
History of Changes
  Purpose

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.


Condition Intervention Phase
Heart Failure
Renal Failure
 Drug: Carperitide heart failure therapy
Drug: Standard heart failure therapy
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: The Effects of Carperitide on Short and Long-term Prognosis in Patients With Both Cardiac and Renal Failure

Resource links provided by NLM:

MedlinePlus related topics: Heart Failure
U.S. FDA Resources

Further study details as provided by Nara Medical University:

Primary Outcome Measures:
  • Unexpected rehospitalization for cardiovascular events, uremic symptom, initiation of maintenance dialysis, and kidney transplantation [ Time Frame: at 6 months and 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • All cause mortality [ Time Frame: at discharge, 6 months, and 2 years ] [ Designated as safety issue: No ]
  • Sudden death [ Time Frame: at discharge, 6 months, and 2 years ] [ Designated as safety issue: No ]
  • Cardiovascular death [ Time Frame: at discharge, 6 months, and 2 years ] [ Designated as safety issue: No ]
  • Plasma B-type natriuretic peptide concentration [ Time Frame: at discharge, 6 months, and 2 years ] [ Designated as safety issue: No ]
  • Estimated GFR [ Time Frame: at discharge, 6 months, and 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: May 2009
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Standard Therapy
Standard heart failure therapy excluding carperitide administration
 Drug: Standard heart failure therapy
Loop diuretics, Aldosterone blockers, Beta blockers, ACE inhibitors, Angiotensin receptor blockers, Nitrates, digitalis
Active Comparator: Carperitide Therapy
Addition of carperitide administration to standard heart failure therapy
 Drug: Carperitide heart failure therapy
carperitide(alpha-human atrial natriuretic peptide, 0.025-0.05μg/kg/min)
Other Name: Loop-diuretics etc + HANP

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00613964

Locations
Japan
First Department of Internal Medicine, Nara Medical University
Nara, Japan, 634-8522
Sponsors and Collaborators
Nara Medical University
Investigators
Study Chair: Yoshihiko Saito, MD, PhD First Department of Internal Medicine, Nara Medical University
  More Information

No publications provided

Responsible Party: Yoshihiko Saito, First Department of Internal Medicine, Nara medical university
ClinicalTrials.gov Identifier: NCT00613964     History of Changes
Other Study ID Numbers: Cardiol001
Study First Received: January 31, 2008
Last Updated: July 20, 2011
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Nara Medical University:
Natriuretic Peptides
Heart Failure
Renal Failure

Additional relevant MeSH terms:
Heart Failure
Renal Insufficiency
Heart Diseases
Cardiovascular Diseases
Kidney Diseases
Urologic Diseases
Diuretics
 Sodium Potassium Chloride Symporter Inhibitors
Natriuretic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 22, 2013