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

September 7, 2007 updated by: University of Roma La Sapienza
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Anticipated)

21

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Rome, viale del Policlinico 155, Italy, 00161
        • Department of Cardiovascular, Respiratory and Morphological Sciences, University of Rome La Sapienza

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
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
0,1,24,48 and 72 hours after Levosimendan infusion started

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Roma La Sapienza

Investigators

  • Principal Investigator: Francesco Fedele, professor, Department of Cardiovascular, Respiratory and Morphological Sciences, University of Rome La Sapienza

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2007

Study Completion (Anticipated)

March 1, 2008

Study Registration Dates

First Submitted

September 7, 2007

First Submitted That Met QC Criteria

September 7, 2007

First Posted (Estimate)

September 10, 2007

Study Record Updates

Last Update Posted (Estimate)

September 10, 2007

Last Update Submitted That Met QC Criteria

September 7, 2007

Last Verified

September 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LEV1068

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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