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

NCT01930734 | Unknown Phase 4

• 1 other identifier: SHEBA-13-0341-DF-CTIL
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• • Improvement in maximal oxygen consumption (VO2 max)

  6 months and 12 months

Secondary Outcomes (1)

• • Combined endpoint of heart failure or all-cause mortality at 6 and 12 months of follow-up

  6 and 12 months

Study Arms (2)

Normal Saline

PLACEBO COMPARATOR

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

Dobutamine

EXPERIMENTAL

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.

Drug: Dobutamine

Interventions

Dobutamine DRUG

Dobutamine infusion up to 5mcg/Kg/min

Also known as: Dobutrex

Dobutamine

Normal Saline DRUG

Normal Saline solution 0.9% Placebo Arm

Normal Saline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Sheba Medical Center: lead

Study Sites (1)

Leviev Heart Center, Chaim Sheba Medical Center

Ramat Gan, 5262179, Israel

Location

MeSH Terms

Conditions

Heart Failure

Interventions

Dobutamine; Saline Solution

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Catecholamines; Amines; Organic Chemicals; Phenethylamines; Ethylamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Dov Freimark, Prof. MD.

  Leviev Heart Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2013
• First Posted: August 29, 2013
• Study Start: October 1, 2013
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2016
• Last Updated: August 30, 2013

Record last verified: 2013-08

Locations

IL (1)