NCT00527059

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
21

participants targeted

Target at below P25 for phase_4 heart-failure

Timeline
Completed

Started Oct 2007

Shorter than P25 for phase_4 heart-failure

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 7, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 10, 2007

Completed
21 days until next milestone

Study Start

First participant enrolled

October 1, 2007

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
Last Updated

September 10, 2007

Status Verified

September 1, 2007

First QC Date

September 7, 2007

Last Update Submit

September 7, 2007

Conditions

Heart FailureRenal Insufficiency

Keywords

Cardiorenal syndrome

Outcome Measures

Primary Outcomes (1)

  • Primary endpoint: GFR measured by inulin Clearance.

    0, 24. 48 and 72 hours after Levosimendan infusion starting

Secondary Outcomes (1)

  • 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.

    0,1,24,48 and 72 hours after Levosimendan infusion started

Study Arms (2)

1

EXPERIMENTAL

patients with acute heart failure

Drug: Levosimendan in addition to standard therapy

2

ACTIVE COMPARATOR

standard therapy for heart failure

Drug: spironolactone, beta-blockers,ecc

Interventions

Levosimendan in addition to standard therapyDRUG

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

1
spironolactone, beta-blockers,eccDRUG
2

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Rome, Viale Del Policlinico 155, 00161, Italy

Location

Related Publications (1)

  • 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.

    PMID: 24464960DERIVED

MeSH Terms

Conditions

Heart FailureRenal InsufficiencyCardio-Renal Syndrome

Interventions

SimendanSpironolactone

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

HydrazonesHydrazinesOrganic ChemicalsPyridazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsLactonesPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Francesco Fedele, professor

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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Francesco Fedele, professor

CONTACT

0039-0649979020francesco.fedele@uniroma1.it

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 7, 2007

First Posted

September 10, 2007

Study Start

October 1, 2007

Study Completion

March 1, 2008

Last Updated

September 10, 2007

Record last verified: 2007-09

Locations

IT(1)