Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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.
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
Sponsor:
Information provided by:
University of Roma La Sapienza

Tracking Information
First Submitted Date  ICMJE September 7, 2007
First Posted Date  ICMJE September 10, 2007
Last Update Posted Date September 10, 2007
Study Start Date  ICMJE October 2007
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: September 7, 2007)
Primary endpoint: GFR measured by inulin Clearance. [ Time Frame: 0, 24. 48 and 72 hours after Levosimendan infusion starting ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: September 7, 2007)
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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE Renal Effects of Levosimendan in Patients Admitted With Acute Decompensated Heart Failure
Official Title  ICMJE Renal Effects of Levosimendan in Patients Admitted With Acute Decompensated Heart Failure
Brief 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.
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.

Study Type  ICMJE Interventional
Study Phase Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Heart Failure
  • Renal Insufficiency
Intervention  ICMJE
  • 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
  • Drug: spironolactone, beta-blockers,ecc
Study Arms
  • Experimental: 1
    patients with acute heart failure
    Intervention: Drug: Levosimendan in addition to standard therapy
  • Active Comparator: 2
    standard therapy for heart failure
    Intervention: Drug: spironolactone, beta-blockers,ecc
Publications * Fedele F, Bruno N, Brasolin B, Caira C, D'Ambrosi A, Mancone M. Levosimendan improves renal function in acute decompensated heart failure: possible underlying mechanisms. Eur J Heart Fail. 2014 Mar;16(3):281-8. doi: 10.1002/ejhf.9. Epub 2013 Dec 11.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: September 7, 2007)
21
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date March 2008
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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.
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00527059
Other Study ID Numbers  ICMJE LEV1068
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE University of Roma La Sapienza
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Francesco Fedele, professor Department of Cardiovascular, Respiratory and Morphological Sciences, University of Rome La Sapienza
PRS Account University of Roma La Sapienza
Verification Date September 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP