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Intermittent Intravenous Levosimendan in Ambulatory Advanced Chronic Heart Failure Patients

NCT01536132 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2016-02-17

No results posted yet for this study

Summary

The purpose of this study is to determine the safety and efficacy of intravenous administration of intermittent doses of levosimendan (infusions of 0,2 μg/kg/min, of levosimendan or placebo, without bolus, for 6 hours every 2 weeks) compared to placebo in ambulatory patients with advanced chronic heart failure.

Conditions

Interventions

DRUG

Levosimendan

0.2 micrograms/kg/min is administered intravenously without bolus for 6 hours every two weeks.

DRUG

Placebo

Placebo (same appearance than active drug) is administered with the same dosing regime

Sponsors & Collaborators

  • Parc de Salut Mar

    lead OTHER

Principal Investigators

  • JOSEP COMIN COLET, MD PHD · HOSPITAL DEL MAR MEDICAL RESEARCH INSTITUTE

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-04-30
Primary Completion
2013-10-31
Completion
2015-11-30

Countries

  • Spain

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01536132 on ClinicalTrials.gov