Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Information provided by (Responsible Party):
Sheba Medical Center

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.


Condition or disease Intervention/treatment Phase
Heart Failure Drug: Dobutamine Drug: Normal Saline Phase 4

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
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

Experimental: 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.
Drug: Dobutamine
Dobutamine infusion up to 5mcg/Kg/min
Other Name: Dobutrex




Primary Outcome Measures :
  1. • Improvement in maximal oxygen consumption (VO2 max) [ Time Frame: 6 months and 12 months ]

Secondary Outcome Measures :
  1. • Combined endpoint of heart failure or all-cause mortality at 6 and 12 months of follow-up [ Time Frame: 6 and 12 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Locations
Layout table for location information
Israel
Leviev Heart Center, Chaim Sheba Medical Center Not yet recruiting
Ramat-Gan, Israel, 5262179
Contact: Eddward Koifman, MD    +972035302642    eddiekoman@gmail.com   
Sponsors and Collaborators
Sheba Medical Center
Investigators
Layout table for investigator information
Principal Investigator: Dov Freimark, Prof. MD. Leviev Heart Center

Layout table for additonal information
Responsible Party: Sheba Medical Center
ClinicalTrials.gov Identifier: NCT01930734     History of Changes
Other Study ID Numbers: SHEBA-13-0341-DF-CTIL
First Posted: August 29, 2013    Key Record Dates
Last Update Posted: August 30, 2013
Last Verified: August 2013
Keywords provided by Sheba Medical Center:
Heart Failure
Dobutamine
Additional relevant MeSH terms:
Layout table for MeSH terms
Heart Failure
Heart Diseases
Cardiovascular Diseases
Dobutamine
Cardiotonic Agents
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic beta-1 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Protective Agents