Levosimendan Versus Dobutamine for Renal Function in Heart Failure

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Study Completion Date

2017-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Although inotropes have a favorable effect on central hemodynamics in patients with heart failure, their effect on renal hemodynamics is incompletely defined. The purpose of this study is to evaluate the efficacy of a 75 min intravenous infusion of levosimendan compared to a 75 min infusion of dobutamine on renal hemodynamics and function in patients with chronic heart failure and signs of cardiorenal syndrome. The investigators hypothesis is that patients treated with levosimendan will show greater increases in renal blood flow and glomerular filtration rate (GFR) than those treated with dobutamine.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Efficacy and Safety of Treatment With Simdax® Versus Dobutrex® in Decompensated Heart Failure Patients.

NCT00219388

Heart Failure

COMPLETED PHASE4

Survival of Patients With Acute Heart Failure in Need of Intravenous Inotropic Support: a Multicentre, Parallel-Group, Randomised, Double-Blind, Double-Dummy Study of Levosimendan Versus Dobutamine in Patients With Acute Heart Failure.

NCT00348504

Acute Heart Failure

COMPLETED PHASE3

Clinical Outcomes of Levosimendan Versus Dobutamine Versus Milrinone in Cases With Acute Decompensated Heart Failure With Impaired Renal Function

NCT07186062

Acute Decompensated Heart Failure (ADHF) Cardiorenal Syndrome (CRS)

COMPLETED

Levosimendan Infusion in Critically Ill Patients With Cardiogenic Shock

NCT04917497

Cardiogenic Shock Cardiorenal Syndrome Acute Kidney Failure

COMPLETED

Peroral Levosimendan in Chronic Heart Failure

NCT00130884

Chronic Heart Failure Heart Diseases

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cardiorenal Syndrome

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Levosimendan

Levosimendan administration is initiated with a loading dose of 12μg/kg given over 10 min followed by a continuous infusion of 0.1 μg/kg/min for 65 min.

Group Type ACTIVE_COMPARATOR

Levosimendan

Intervention Type DRUG

Dobutamine

Dobutamine is given as a continuous infusion without a bolus dose. The infusion rate is started at 5.0 μg/kg/min for 10 minutes, and thereafter increased to 7,5 μg/kg/min for 65 min.

Group Type ACTIVE_COMPARATOR

Dobutamine

Intervention Type DRUG

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Levosimendan

Intervention Type DRUG

Dobutamine

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Simdax Dobutrex

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Written, signed and dated informed consent
* Male and Female subjects ≥18 years of age
* Chronic congestive heart failure scheduled for right sided cardiac catheterization
* Left ventricular ejection fraction ≤ 40% determined by echocardiography
* Elevation of N Terminal-proBNP ≥ 500 ng/L
* Cardiorenal syndrome (30ml/min ≤ estimated GFR ≤ 80 ml/min (MDRD)

Exclusion Criteria

* Acute heart failure, untreated
* Systolic blood pressure \< 80 mmHg
* Tachycardia above 100 bpm
* Angina Canadian Cardiovascular Society (CCS) class III or higher
* Aortic stenosis
* Hypertrophic cardiomyopathy
* Restrictive cardiomyopathy
* The presence of kidney disease diagnosed before heart failure
* Administration of radiographic contrast \< 1 week
* Radiographic contrast allergy
* In the Investigator's opinion, the patient has a clinically significant disease that could be adversely affected by study participation

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No