Heart Failure Clinical Trial
Official title:
Effect of Levosimendan or Placebo on Exercise Capacity and Hemodynamics in Patients With Advanced Chronic Heart Failure (LOCO-CHF Trial)
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.
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.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05196659 -
Collaborative Quality Improvement (C-QIP) Study
|
N/A | |
Recruiting |
NCT05650307 -
CV Imaging of Metabolic Interventions
|
||
Recruiting |
NCT05654272 -
Development of CIRC Technologies
|
||
Active, not recruiting |
NCT05896904 -
Clinical Comparison of Patients With Transthyretin Cardiac Amyloidosis and Patients With Heart Failure With Reduced Ejection Fraction
|
N/A | |
Completed |
NCT05077293 -
Building Electronic Tools To Enhance and Reinforce Cardiovascular Recommendations - Heart Failure
|
||
Recruiting |
NCT05631275 -
The Role of Bioimpedance Analysis in Patients With Chronic Heart Failure and Systolic Ventricular Dysfunction
|
||
Enrolling by invitation |
NCT05564572 -
Randomized Implementation of Routine Patient-Reported Health Status Assessment Among Heart Failure Patients in Stanford Cardiology
|
N/A | |
Enrolling by invitation |
NCT05009706 -
Self-care in Older Frail Persons With Heart Failure Intervention
|
N/A | |
Recruiting |
NCT04177199 -
What is the Workload Burden Associated With Using the Triage HF+ Care Pathway?
|
||
Terminated |
NCT03615469 -
Building Strength Through Rehabilitation for Heart Failure Patients (BISTRO-STUDY)
|
N/A | |
Recruiting |
NCT06340048 -
Epicardial Injection of hiPSC-CMs to Treat Severe Chronic Ischemic Heart Failure
|
Phase 1/Phase 2 | |
Recruiting |
NCT05679713 -
Next-generation, Integrative, and Personalized Risk Assessment to Prevent Recurrent Heart Failure Events: the ORACLE Study
|
||
Completed |
NCT04254328 -
The Effectiveness of Nintendo Wii Fit and Inspiratory Muscle Training in Older Patients With Heart Failure
|
N/A | |
Completed |
NCT03549169 -
Decision Making for the Management the Symptoms in Adults of Heart Failure
|
N/A | |
Recruiting |
NCT05572814 -
Transform: Teaching, Technology, and Teams
|
N/A | |
Enrolling by invitation |
NCT05538611 -
Effect Evaluation of Chain Quality Control Management on Patients With Heart Failure
|
||
Recruiting |
NCT04262830 -
Cancer Therapy Effects on the Heart
|
||
Completed |
NCT06026683 -
Conduction System Stimulation to Avoid Left Ventricle Dysfunction
|
N/A | |
Withdrawn |
NCT03091998 -
Subcu Administration of CD-NP in Heart Failure Patients With Left Ventricular Assist Device Support
|
Phase 1 | |
Recruiting |
NCT05564689 -
Absolute Coronary Flow in Patients With Heart Failure With Reduced Ejection Fraction and Left Bundle Branch Block With Cardiac Resynchronization Therapy
|