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

Study Overview
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Brief Summary
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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.

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

Conditions
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Heart Failure, Renal Failure

Intervention / Treatment
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* Drug: Carperitide heart failure therapy
* Drug: Standard heart failure therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Standard Therapy<br>Standard heart failure therapy excluding carperitide administration | Drug: Standard heart failure therapy<br>* Loop diuretics, Aldosterone blockers, Beta blockers, ACE inhibitors, Angiotensin receptor blockers, Nitrates, digitalis<br>|
| Active Comparator: Carperitide Therapy<br>Addition of carperitide administration to standard heart failure therapy | Drug: Carperitide heart failure therapy<br>* carperitide(alpha-human atrial natriuretic peptide, 0.025-0.05μg/kg/min)<br>* Other names: Loop-diuretics etc + HANP;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Unexpected rehospitalization for cardiovascular events, uremic symptom, initiation of maintenance dialysis, and kidney transplantation |  | at 6 months and 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Natriuretic Peptides, Heart Failure, Renal Failure