Renal Effects of Levosimendan in Patients Admitted With Acute Decompensated Heart Failure
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|ClinicalTrials.gov Identifier: NCT00527059|
Recruitment Status : Unknown
Verified September 2007 by University of Roma La Sapienza.
Recruitment status was: Not yet recruiting
First Posted : September 10, 2007
Last Update Posted : September 10, 2007
|Condition or disease||Intervention/treatment||Phase|
|Heart Failure Renal Insufficiency||Drug: Levosimendan in addition to standard therapy Drug: spironolactone, beta-blockers,ecc||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||21 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Renal Effects of Levosimendan in Patients Admitted With Acute Decompensated Heart Failure|
|Study Start Date :||October 2007|
|Estimated Study Completion Date :||March 2008|
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
Active Comparator: 2
standard therapy for heart failure
Drug: spironolactone, beta-blockers,ecc
- Primary endpoint: GFR measured by inulin Clearance. [ Time Frame: 0, 24. 48 and 72 hours after Levosimendan infusion starting ]
- Secondary endpoints: •Other renal function measures: BUN, albumin, urine volume, sodium excretion and plasma sodium, and cystatin. •Hemodynamic parameters: PCWP, PAP, cardiac output, HR, BP, renal blood flow. [ Time Frame: 0,1,24,48 and 72 hours after Levosimendan infusion started ]
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): NCT00527059
|Contact: Francesco Fedele, firstname.lastname@example.org|
|Department of Cardiovascular, Respiratory and Morphological Sciences, University of Rome La Sapienza||Not yet recruiting|
|Rome, viale del Policlinico 155, Italy, 00161|
|Principal Investigator:||Francesco Fedele, professor||Department of Cardiovascular, Respiratory and Morphological Sciences, University of Rome La Sapienza|