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

NCT ID: NCT01930734

Last Updated: 2013-08-30

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-31
• Study Completion Date: 2016-10-31

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.

Conditions

Heart Failure

Keywords

Heart Failure; Dobutamine

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: PLACEBO_COMPARATOR

Normal Saline

Intervention Type: DRUG

Normal Saline solution 0.9% Placebo Arm

Dobutamine

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.

Group Type: EXPERIMENTAL

Dobutamine

Intervention Type: DRUG

Dobutamine infusion up to 5mcg/Kg/min

Interventions

Dobutamine

Dobutamine infusion up to 5mcg/Kg/min

Intervention Type: DRUG

Normal Saline

Normal Saline solution 0.9% Placebo Arm

Intervention Type: DRUG

Other Intervention Names

Dobutrex

Eligibility Criteria

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 β-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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sheba Medical Center

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dov Freimark, Prof. MD.

Role: PRINCIPAL_INVESTIGATOR

Leviev Heart Center

Locations

Leviev Heart Center, Chaim Sheba Medical Center

Ramat Gan, , Israel

Countries

Israel

Facility Contacts

Eddward Koifman, MD

Role: primary

Other Identifiers

SHEBA-13-0341-DF-CTIL

Identifier Type: -

Identifier Source: org_study_id