Outcome and Safety of Intermittent Dobutamine Infusion at a Day-Care Center in Advanced Heart Failure Patients (DoBHF)
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|ClinicalTrials.gov Identifier: NCT01930734|
Recruitment Status : Unknown
Verified August 2013 by Sheba Medical Center.
Recruitment status was: Not yet recruiting
First Posted : August 29, 2013
Last Update Posted : August 30, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Heart Failure||Drug: Dobutamine Drug: Normal Saline||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Randomized-Controlled-Double Blind Trial of Low Dose Dobutamine in Advanced Heart Failure Patients in a Day-Care Clinic|
|Study Start Date :||October 2013|
|Estimated Primary Completion Date :||October 2015|
|Estimated Study Completion Date :||October 2016|
Placebo Comparator: Normal Saline
Normal Saline Placebo infusion containing Normal Saline NaCl 0.9% twice a week for a total duration of 6 months.
Placebo will be given at the same rate as the Dobutamine infusion, under the same measures.
Drug: Normal Saline
Normal Saline solution 0.9% Placebo Arm
Twice weekly, IV Dobutamine infusion up to 5mcg/Kg/min infusion, for the duration of 6 months. Medication will be administered under medical supervision and continues ECG and vital sign monitoring. Routine electrolyte and renal function testing will be performed and electrolytes corrected as indicated.
Dobutamine infusion up to 5mcg/Kg/min
Other Name: Dobutrex
- • Improvement in maximal oxygen consumption (VO2 max) [ Time Frame: 6 months and 12 months ]
- • Combined endpoint of heart failure or all-cause mortality at 6 and 12 months of follow-up [ Time Frame: 6 and 12 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01930734
|Leviev Heart Center, Chaim Sheba Medical Center|
|Ramat-Gan, Israel, 5262179|
|Contact: Eddward Koifman, MD +972035302642 email@example.com|
|Principal Investigator:||Dov Freimark, Prof. MD.||Leviev Heart Center|