Chronic Stable Heart Failure Clinical Trial
Official title:
Efficacy and Safety of Pulsed Infusions of Levosimendan in Outpatients With Advanced Heart Failure - A Multicenter, Double-blind, Placebo Controlled Prospective Trial With Two Arms
The purpose of this study is to compare the effects of a pulsed application of Levosimendan versus placebo on the composite end-point functional capacity and quality of life.
BACKGROUND Significant advances have been made in the treatment of congestive heart failure
(CHF) in the past few years. Neurohumoral therapy with ACE-inhibitors, ß-blockers and
aldosterone antagonists has been established to significantly reduce morbidity and
mortality. However, despite the advances of modern therapy advanced CHF remains a syndrome
with a poor prognosis. Additionally, this syndrome is associated with poor quality of life
and leads to progressive debiliation and cardial cachexia. Repeat hospitalizations for acute
heart failure are common among severe CHF patients. Besides the discomfort for the patients
hospital admissions constitute the lion's share of the health expenditure for the heart
failure syndrome.
Inotropic support is provided to patients suffering acute heart failure refractory to
neurohumoral therapy. This approach is performed according to the AHA/ACC- as well as to ESC
Guidelines for therapy of CHF. Inotropic therapy is targeted on hemodynamic stabilization,
improvement of functional status, and reduction of rehospitalization.
Moreover, in many centres treatment with inotropes such as dobutamine and milrinone are an
integral part of the applied bridge to transplant concept in severe heart failure patients.
In fact, continuous or pulsed inotropic support in severe heart failure patients has been
tested repeatedly in small clinical studies.
Intermittent ambulatory low dose administration of dobutamine versus conventional therapy
did not improve functional capacity in the DICE-Trial. By contrast, several case series with
different dose regimens of dobutamine indicated improvement of functional status.
TRIAL RATIONALE Based on its pharmacologic profile Levosimendan appears to be promising in
the treatment of severe chronic heart failure functional NYHA class III/IV to improve
quality of life and physical activity and to reduce hospital admissions for acute heart
failure.
Repeat drug administration may be superior over a single shot therapy to maintain beneficial
long-term results.
For economical reasons and for the sake of the patients comfort drug administration should
ideally be managed on an outpatient basis rather than in the hospital. Therefore and for
practical reasons, a time period of six hours for drug administration might be reasonable.
Dosing of the drug will be based on the experiences in the Russlan Trial and on a small case
report by Martys. In the latter study serial administration of levosimendan for 6 hours
(bolus of 12 mcg/kg followed by a continuous infusion of 0,1 μg/kg/min for 50min and 0,2
μg/kg/min for the next 5 hours) induced a significant fall of BNP.
In an outpatient setting, however, a bolus should be not be given for safety reasons.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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