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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:
ClinicalTrials.gov Identifier:
NCT00613964
First Posted: February 13, 2008
Last Update Posted: July 22, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Nara Medical University
  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
Intervention Model: Parallel Assignment
Masking: Single (Participant)
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:


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 ]

Secondary Outcome Measures:
  • All cause mortality [ Time Frame: at discharge, 6 months, and 2 years ]
  • Sudden death [ Time Frame: at discharge, 6 months, and 2 years ]
  • Cardiovascular death [ Time Frame: at discharge, 6 months, and 2 years ]
  • Plasma B-type natriuretic peptide concentration [ Time Frame: at discharge, 6 months, and 2 years ]
  • Estimated GFR [ Time Frame: at discharge, 6 months, and 2 years ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Yoshihiko Saito, First Department of Internal Medicine, Nara medical university
ClinicalTrials.gov Identifier: NCT00613964     History of Changes
Other Study ID Numbers: Cardiol001
First Submitted: January 31, 2008
First Posted: February 13, 2008
Last Update Posted: July 22, 2011
Last Verified: February 2009

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
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action