Renal Effects of Levosimendan in Patients Admitted With Acute Decompensated Heart Failure
Information source: University of Roma La Sapienza
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Heart Failure; Renal Insufficiency
Intervention: Levosimendan in addition to standard therapy (Drug); spironolactone, beta-blockers,ecc (Drug)
Phase: Phase 4
Status: Not yet recruiting
Sponsored by: University of Roma La Sapienza Official(s) and/or principal investigator(s):
Francesco Fedele, professor, Principal Investigator, Affiliation: Department of Cardiovascular, Respiratory and Morphological Sciences, University of Rome La Sapienza
Overall contact:
Francesco Fedele, professor, Phone: 0039-0649979020, Email: francesco.fedele@uniroma1.it
Summary
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.
Clinical Details
Official title: Renal Effects of Levosimendan in Patients Admitted With Acute Decompensated Heart Failure
Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Primary outcome: Primary endpoint:
GFR measured by inulin Clearance.
Secondary outcome: 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.
Detailed description:
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.
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- an ejection fraction (EF) 40% by transthoracic echocardiogram,
- a baseline pulmonary capillary wedge pressure (PCWP) 20 mm Hg
- a MDRD (Modification of Diet Renal Disease) score > 30 and < 60
- and a standard therapy for HF that should include angiotensin converting enzyme
inhibitors, angiotensin receptor blockers, aldosterone blocking agents
(spironolactone) and beta-blockers, unless contraindicated
Exclusion Criteria:
- patients receiving other oral or i. v. inotropes,
- oral or i. v. diuretics
- or receiving nitroglycerine or nitroprusside,
- patients with systolic blood pressure <110 mmHg,
- mechanical ventilation,
- anticipated survival <30 days,
- absence of thoracic windows for echocardiography,
- acute coronary syndromes,
- sustained ventricular tachycardia or ventricular fibrillation,
- documented renal artery stenosis, requiring dialysis,
- requiring admission primarily for concurrent morbidity,
- severe aortic or mitral regurgitation,
- left ventricular failure primarily from uncorrected obstructive valvular disease,
hypertrophic obstructive cardiomyopathy, restrictive/obstructive cardiomyopathy,
- uncorrected thyroid disease,
- known amyloid cardiomyopathy
- or known malfunctioning artificial heart valve.
Locations and Contacts
Francesco Fedele, professor, Phone: 0039-0649979020, Email: francesco.fedele@uniroma1.it
Department of Cardiovascular, Respiratory and Morphological Sciences, University of Rome La Sapienza, Rome, viale del Policlinico 155 00161, Italy
Additional Information
Starting date: October 2007
Ending date: March 2008
Last updated: September 7, 2007
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