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Sponsored by: |
University of Roma La Sapienza |
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Information provided by: | University of Roma La Sapienza |
ClinicalTrials.gov Identifier: | NCT00527059 |
The purpose of this study is to evaluate the effect of levosimendan infusion, in addition to standard therapy,on renal function in patients with Acute Heart Failure,compared with standard therapy alone.
Condition | Intervention | Phase |
---|---|---|
Heart Failure Renal Insufficiency |
Drug: Levosimendan in addition to standard therapy Drug: spironolactone, beta-blockers,ecc |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Renal Effects of Levosimendan in Patients Admitted With Acute Decompensated Heart Failure |
Estimated Enrollment: | 21 |
Study Start Date: | October 2007 |
Estimated Study Completion Date: | March 2008 |
Arms | Assigned Interventions |
---|---|
1: Experimental
patients with acute heart failure
|
Drug: Levosimendan in addition to standard therapy
intravenous infusion of levosimendan (10 minutes bolus with 6 mcg/Kg according to physician judgement, followed by 0.1 mcg/Kg/min for 24 hours) in addition to standard therapy
|
2: Active Comparator
standard therapy for heart failure
|
Drug: spironolactone, beta-blockers,ecc |
The term "cardiorenal syndrome" has been applied to the presence or development of a renal dysfunction in HF patients and may be the major precipitant of decompensation and cause for admission in these patients. The renal hypoperfusion that occurs with cardiac injury can lead to sodium and water retention and activation of the renin-angiotensin-aldosterone system and neurohormonal pathways with resultant deleterious effects on the myocardium. A vicious cycle may then ensue and be associated with increased cardiovascular complications. In this regard, renal dysfunction is of a functional nature and thus means to intervene with this vicious cycle need to be sought.
Several studies already demonstrated the deleterious effects of renal dysfunction on prognosis in patients with HF due to chronic left ventricular dysfunction.
Levosimendan increases myocardial contractility without significant changes in the intracellular calcium ion and cyclic adenosine monophosphate concentrations and does not enhance myocardial oxygen demand. By its action on the potassium channels this drug also dilates the coronary and peripheral arteries and exerts an anti-ischemic,anti-stunning effect. To date, the effects of levosimendan on renal function in patients with worsening chronic HF, remain unknown.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Francesco Fedele, professor | 0039-0649979020 | francesco.fedele@uniroma1.it |
Italy | |
Department of Cardiovascular, Respiratory and Morphological Sciences, University of Rome La Sapienza | |
Rome, viale del Policlinico 155, Italy, 00161 |
Principal Investigator: | Francesco Fedele, professor | Department of Cardiovascular, Respiratory and Morphological Sciences, University of Rome La Sapienza |
Study ID Numbers: | LEV1068 |
Study First Received: | September 7, 2007 |
Last Updated: | September 7, 2007 |
ClinicalTrials.gov Identifier: | NCT00527059 |
Health Authority: | Italy: Ethics Committee |
Cardiorenal syndrome |
Heart Failure Renal Insufficiency Heart Diseases Urologic Diseases |
Kidney Diseases Spironolactone Simendan |
Vasodilator Agents Molecular Mechanisms of Pharmacological Action Cardiotonic Agents Hormone Antagonists Diuretics Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Enzyme Inhibitors Cardiovascular Agents |
Protective Agents Pharmacologic Actions Phosphodiesterase Inhibitors Aldosterone Antagonists Natriuretic Agents Therapeutic Uses Cardiovascular Diseases Anti-Arrhythmia Agents |