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

Primary Purpose

Heart Failure, Renal Insufficiency

Status
Unknown status
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
Levosimendan in addition to standard therapy
spironolactone, beta-blockers,ecc
Sponsored by
University of Roma La Sapienza
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure focused on measuring Cardiorenal syndrome

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Department of Cardiovascular, Respiratory and Morphological Sciences, University of Rome La Sapienza

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

patients with acute heart failure

standard therapy for heart failure

Outcomes

Primary Outcome Measures

Primary endpoint: GFR measured by inulin Clearance.

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.

Full Information

First Posted
September 7, 2007
Last Updated
September 7, 2007
Sponsor
University of Roma La Sapienza
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1. Study Identification

Unique Protocol Identification Number
NCT00527059
Brief Title
Renal Effects of Levosimendan in Patients Admitted With Acute Decompensated Heart Failure
Official Title
Renal Effects of Levosimendan in Patients Admitted With Acute Decompensated Heart Failure
Study Type
Interventional

2. Study Status

Record Verification Date
September 2007
Overall Recruitment Status
Unknown status
Study Start Date
October 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2008 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
University of Roma La Sapienza

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Renal Insufficiency
Keywords
Cardiorenal syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
21 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
patients with acute heart failure
Arm Title
2
Arm Type
Active Comparator
Arm Description
standard therapy for heart failure
Intervention Type
Drug
Intervention Name(s)
Levosimendan in addition to standard therapy
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
spironolactone, beta-blockers,ecc
Primary Outcome Measure Information:
Title
Primary endpoint: GFR measured by inulin Clearance.
Time Frame
0, 24. 48 and 72 hours after Levosimendan infusion starting
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Francesco Fedele, professor
Phone
0039-0649979020
Email
francesco.fedele@uniroma1.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francesco Fedele, professor
Organizational Affiliation
Department of Cardiovascular, Respiratory and Morphological Sciences, University of Rome La Sapienza
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Cardiovascular, Respiratory and Morphological Sciences, University of Rome La Sapienza
City
Rome, viale del Policlinico 155
ZIP/Postal Code
00161
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
24464960
Citation
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.
Results Reference
derived

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

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