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

Heart Failure Clinical Trial

— DoBHF  

Official title:

Randomized-Controlled-Double Blind Trial of Low Dose Dobutamine in Advanced Heart Failure Patients in a Day-Care Clinic

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01930734
• Other study ID #: SHEBA-13-0341-DF-CTIL
• Status: Not yet recruiting
• Phase: Phase 4
• First received: August 25, 2013
• Last updated: August 29, 2013
• Start date: October 2013
• Est. completion date: October 2016

Study information

• Verified date: August 2013
• Source: Sheba Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: October 2016
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age over 18

• Symptomatic HF with NYHA III-IV

• Left ventricular ejection fraction < 30%

• Maximal tolerated dosage of Angiotensin receptor blocker (ARB) or Angiotensin converting enzyme inhibitor (ACEI), aldosterone antagonists and ß-Blockers according to blood pressure, heart rate, renal function and potassium levels

• Prior implementation of resynchronization therapy and implantable defibrillator as indicated??

• Prior HF hospitalization in the past 12 months

• Unsatisfactory response to intravenous diuretics during hospitalization or ambulatory care.

Exclusion Criteria:

• Active ischemia

• Acute coronary syndrome or cardiac surgery within 3 months

• Hemodynamic and respiratory instability, with systolic blood pressure below 85mmHg, and oxygen saturation below 90% at rest

• Uncontrolled hypertension >180/110 mmHg

• Contra-indication to dobutamine therapy

• Hemodialysis therapy

• Malignant ventricular arrythmias

• Drug or alcohol abuse

• Sepsis or ongoing systemic infection

• Active myocarditis

• Severe valvular stenosis

• Non-compliance

• Life-threatening extra-cardiac disease or malignancy with a life expectancy below 1 year

• Inability to sign an informed consent

• Participation in another trial during the previous 6 months

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Heart Failure

Intervention

Drug:
• Dobutamine
Dobutamine infusion up to 5mcg/Kg/min
• Normal Saline
Normal Saline solution 0.9% Placebo Arm

Locations

Country	Name	City	State
Israel	Leviev Heart Center, Chaim Sheba Medical Center	Ramat-Gan

Sponsors (1)

Lead Sponsor	Collaborator
Sheba Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	• Improvement in maximal oxygen consumption (VO2 max)		6 months and 12 months	No
Secondary	• Combined endpoint of heart failure or all-cause mortality at 6 and 12 months of follow-up		6 and 12 months	Yes