Ignite Creation Date:
2025-12-25 @ 2:30 AM
Ignite Modification Date:
2026-04-14 @ 10:45 PM
Study NCT ID:
NCT01930734
Status:
UNKNOWN
Last Update Posted:
2013-08-30
First Post:
2013-08-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Outcome and Safety of Intermittent Dobutamine Infusion at a Day-Care Center in Advanced Heart Failure Patients
Sponsor:
Sheba Medical Center
Organization:
Study Overview
Official Title:
Randomized-Controlled-Double Blind Trial of Low Dose Dobutamine in Advanced Heart Failure Patients in a Day-Care Clinic
Status:
UNKNOWN
Status Verified Date:
2013-08
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DoBHF
Brief 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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: