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Outcome and Safety of Intermittent Dobutamine Infusion at a Day-Care Center in Advanced Heart Failure Patients

NCT01930734 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2013-08-30

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Dobutamine

Dobutamine infusion up to 5mcg/Kg/min

DRUG

Normal Saline

Normal Saline solution 0.9% Placebo Arm

Sponsors & Collaborators

  • Sheba Medical Center

    lead OTHER_GOV

Principal Investigators

  • Dov Freimark, Prof. MD. · Leviev Heart Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-10-31
Primary Completion
2015-10-31
Completion
2016-10-31

Countries

  • Israel

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01930734 on ClinicalTrials.gov