Clinical Trials Logo

Clinical Trial Summary

Purpose: This study evaluates the subacute effect of levosimendan infusion on exercise capacity and exercise hemodynamics compared with placebo in patients with advanced chronic heart failure.

Hypothesis: Treatment with 6 hours infusion of levosimendan compared with placebo improves exercise capacity and exercise hemodynamics evaluated by change in CO/PCWP.

Design: The study is a prospective multi-center, double-blinded, placebo controlled randomized study. 42 consecutive patients who meet the eligibility criteria will be enrolled.


Clinical Trial Description

Background: Patients with advanced heart failure (HF) symptoms (NYHA III-IV) have poor quality of life and significantly impaired functional capacity despite optimal medical management. Exercise intolerance in HF results from multiple pathophysiological processes, but central hemodynamics during exercise are important determinants. In patients with advanced HF, intermittent levosimendan infusion is sometimes used to relieve symptoms and possibly improve prognosis. A short-term effect of levosimendan infusion on exercise capacity has previously been reported. However, the underlying mechanisms behind such an improvement, as well as more durable effects of levosimendan on exercise capacity in advanced chronic HF, have not been clearly established. Also the hemodynamic effect of levosimendan has not been investigated in advanced chronic HF during exercise.

To our knowledge no previous studies have evaluated the subacute effect of levosimendan infusion on exercise capacity and exercise hemodynamics in patients with advanced chronic HF. This study will hopefully improve the understanding of the role of levosimendan in the management of these patients.

Purpose: This study evaluates the subacute effect of levosimendan infusion on exercise capacity and exercise hemodynamics compared with placebo in patients with advanced chronic HF.

Hypothesis: Treatment with 6 hours infusion of levosimendan 0.2 µg/kg/min compared with placebo improves exercise capacity and exercise hemodynamics evaluated by change in CO/PCWP (Day 0 to Day 5 (4-6) after infusion) in patients with advanced chronic HF.

Design: The study is a prospective multi-center, double-blinded, placebo controlled randomized study. The study population will consist of 42 consecutive patients who meet the eligibility criteria. Patients will be randomized 1:1 to treatment with either levosimendan or placebo. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03576677
Study type Interventional
Source Rigshospitalet, Denmark
Contact Finn Gustafsson, MD, professor, PhD, DMSci
Phone +45 35459743
Email finng@dadlnet.dk
Status Not yet recruiting
Phase Phase 4
Start date August 1, 2018
Completion date July 30, 2020

See also
  Status Clinical Trial Phase
Recruiting NCT03615469 - Building Strength Through Rehabilitation for Heart Failure Patients (BISTRO-STUDY) N/A
Active, not recruiting NCT03549169 - Decision Making for the Management the Symptoms in Adults of Heart Failure N/A
Withdrawn NCT03091998 - Subcu Administration of CD-NP in Heart Failure Patients With Left Ventricular Assist Device Support Phase 1
Recruiting NCT03087084 - RESpiration deTection From Implanted Cardiac Devices in Subjects With Heart Failure (REST-HF) N/A
Recruiting NCT03300791 - Predictive Models of Readmission in Heart Failure N/A
Completed NCT03294512 - Pilot and Feasibility Study of a MAWDS (Medications, Activity, Weight, Diet and Symptoms) Heart Failure Mobile Platform N/A
Recruiting NCT03565328 - The Effect of Nicotinamide Riboside on Skeletal Muscle Function in Heart Failure Subjects Phase 2
Recruiting NCT03560167 - Early Feasibility Study of the AccuCinch® Ventricular Repair System in Patients With Prior Mitral Valve Intervention (PMVI) and Recurrent Mitral Regurgitation - The CorCinch-PMVI Study N/A
Not yet recruiting NCT03647891 - Impact of Early Diagnosis and Treatment of OSA on Hospital Readmission in Hospitalized Cardiac Patients N/A
Recruiting NCT03281122 - A Study of BMS-986224 in Healthy Subjects and Heart Failure Patients With Reduced Ejection Fraction Phase 1
Recruiting NCT02275819 - Exercise Training in Heart Failure: Changes in Cardiac Structure and Function
Completed NCT03238729 - Proof-of-Concept Study of Heart Habits Application for Patients With Heart Failure N/A
Not yet recruiting NCT03360448 - AC6 Gene Transfer in Patients With Reduced Left Ventricular Ejection Fraction Heart Failure Phase 3
Not yet recruiting NCT03587064 - Comparison of CRT-D and CRT-DX Systems (CRT-NEXT) N/A
Not yet recruiting NCT02784912 - Biomarkers in Risk Stratification of Sustainted Ventricular Tachycardia or Electrical Storm After Ablation N/A
Recruiting NCT02674438 - Comparison of Outcomes and Access to Care for Heart Failure Trial Phase 3
Recruiting NCT02922478 - Role of Comorbidities in Chronic Heart Failure Study N/A
Recruiting NCT03013270 - Aerobic, Resistance, Inspiratory Training Outcomes in Heart Failure N/A
Recruiting NCT02911493 - Reducing Sedentary Time in Patients With Heart Failure N/A
Recruiting NCT02823795 - The Supporting Patient Activation in Transition to Home Intervention N/A