Outcome and Safety of Intermittent Dobutamine Infusion at a Day-Care Center in Advanced Heart Failure Patients
Status:
Unknown status
Trial end date:
2016-10-01
Target enrollment:
Participant gender:
Summary
Heart failure (HF) is a prevalent disease reaching 1-2% of adult population in developed
countries, and 10% in patients over 70 years. In the past HF patients had a 5-year mortality
rate of 60-70% of HF with high rate of hospitalization and disability leading to a HF
epidemic. Treatment improvements in the past decades have significantly reduced
hospitalization and mortality. However, there is an increasing subset of patients (>10%) with
advanced HF symptoms (functional class III/IV) for whom current management strategies are
limited and do not provide a significant improvement in morbidity, mortality and quality of
life.
Specialized HF clinics, implementing a comprehensive therapeutic approach, were suggested to
be beneficial in this population. However, the design of these clinics is variable with
different methods of follow-up, therapy and supervision. Intermittent infusions of dobutamine
were previously inconclusive regarding symptom alleviation and hemodynamic improvement and
raised a concern of increased mortality in HF patients. Furthermore, the evidence scope is
narrow since most trials including inconsistent and relatively high dobutamine dosages.
Accordingly, current guidelines do not provide specific recommendations for dobutamine
therapy in stable HF patients, and indication for treatment are limited for acute HF with
hypotension and signs of hypoperfusion, or alleviation of symptoms in severely symptomatic
patients in stage D HF.
The primary aim of the proposed study is to evaluate the impact of intermittent low-dose
dobutamine infusion on clinical and hemodynamic parameters in advanced HF patients treated in
a tertiary heart failure clinic in the setting of a randomized clinical trial. We hypothesize
that intermittent therapy with low-dose dobutamine will be associated with improved
functional capacity and quality of life among patients with advanced heart failure, thereby
providing evidence for beneficial effects of a potentially important therapeutic regimen in
this high risk population.