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Renal Effects of Levosimendan in Patients Admitted With Acute Decompensated Heart Failure

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2007 by University of Roma La Sapienza.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00527059
First Posted: September 10, 2007
Last Update Posted: September 10, 2007
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:
University of Roma La Sapienza
  Purpose
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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Renal Effects of Levosimendan in Patients Admitted With Acute Decompensated Heart Failure

Resource links provided by NLM:


Further study details as provided by University of Roma La Sapienza:

Primary Outcome Measures:
  • Primary endpoint: GFR measured by inulin Clearance. [ Time Frame: 0, 24. 48 and 72 hours after Levosimendan infusion starting ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 21
Study Start Date: October 2007
Estimated Study Completion Date: March 2008
Arms Assigned Interventions
Experimental: 1
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

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

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  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): NCT00527059


Contacts
Contact: Francesco Fedele, professor 0039-0649979020 francesco.fedele@uniroma1.it

Locations
Italy
Department of Cardiovascular, Respiratory and Morphological Sciences, University of Rome La Sapienza Not yet recruiting
Rome, viale del Policlinico 155, Italy, 00161
Sponsors and Collaborators
University of Roma La Sapienza
Investigators
Principal Investigator: Francesco Fedele, professor Department of Cardiovascular, Respiratory and Morphological Sciences, University of Rome La Sapienza
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00527059     History of Changes
Other Study ID Numbers: LEV1068
First Submitted: September 7, 2007
First Posted: September 10, 2007
Last Update Posted: September 10, 2007
Last Verified: September 2007

Keywords provided by University of Roma La Sapienza:
Cardiorenal syndrome

Additional relevant MeSH terms:
Heart Failure
Renal Insufficiency
Heart Diseases
Cardiovascular Diseases
Kidney Diseases
Urologic Diseases
Spironolactone
Adrenergic beta-Antagonists
Simendan
Mineralocorticoid Receptor Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Diuretics, Potassium Sparing
Diuretics
Natriuretic Agents
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Arrhythmia Agents
Cardiotonic Agents
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Vasodilator Agents
Protective Agents