Use of Beta-agonists in Stable Severe Congestive Heart Failure

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. Identifier: NCT01447069
Recruitment Status : Unknown
Verified August 2011 by Rabin Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : October 5, 2011
Last Update Posted : October 5, 2011
Information provided by (Responsible Party):
Rabin Medical Center

Brief Summary:
The purpose of this study is to determine whether Salbutamol is effective in the treatment of severe heart failure due to ischemic and non- ischemic cardiomyopathy.

Condition or disease Intervention/treatment Phase
Ischemic Cardiomyopathy Non-ischemic Cardiomyopathy Heart Failure Drug: Salbutamol Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : October 2011
Estimated Primary Completion Date : March 2012
Estimated Study Completion Date : March 2012

Arm Intervention/treatment
Active Comparator: Salbutamol
The patients in the study groups will receive the selective β2 agonist, Salbutamol, in addition to their ongoing optimal heart failure therapy.
Drug: Salbutamol
The initial dose will be 0.5mg bid, with acceleration of the dose every two weeks by 1mg, up to a maximal dose of 2mg bid or an increase in heart rate by 50% above the baseline heart rate, as long as it remains <100 bpm
No Intervention: control
The patients in the control group will continue with their regular optimal medical therapy without any intervention.

Primary Outcome Measures :
  1. Changes in plasma level of N-terminal pro-BNP at twelve weeks relative to baseline pro-BNP. [ Time Frame: 12 weeks from baseline pro-BNP assessment ]

Secondary Outcome Measures :
  1. Adverse cardiovascular event: Death, ICD discharge, significant ventricular arrhythmias and hospitalization due to heart failure exacerbation [ Time Frame: 12 weeks after baseline assessment ]
    Record events of death, ICD discharge and hospitalization due to heart failure exacerbation. Interrogate ICD memory for significant ventricular arrhythmias (ventricular tachycardia and ventricular fibrillation) that did not cause ICD discharge.

  2. NYHA class changes [ Time Frame: 12 weeks after baseline assessment ]
    We will assess NYHA functional class at baseline and after 12 weeks from the beginning of study medication.

  3. Echocardiography parameters changes [ Time Frame: 12 weeks after baseline assessment ]

    END-SYSTOLIC DIAMETER: _ _ _ MM END-DIASTOLIC DIAMETER: _ _ _ MM LVEF (SIMPSON'S) : _____% Left atrial diameter: ____MM Left atrial area:______cm2 dP/dT: ___32/∆t (mm Hg/msec) E/A: ___ E': ___ cm/s E/E': _____ E wave deceleration time:_____msec Isovolumic relaxation time (IVRT):_____msec

    Dimensionless myocardial performance index (MPI) (n<0.4) :

    MPI=(TST-ET)/ET TST- total systolic time -from the end of mitral inflow A wave to the beginning of mitral inflow E wave ET - ejection time - time from the beginning to the end of left ventricular outflow tract Doppler envelope

  4. Minnesota Living with Heart Failure Questionnaire changes [ Time Frame: 12 weeks after baseline assessment ]
    repeat Minnesota Living with Heart Failure Questionnaire assessment

  5. Non-ventricular arrhythmias and electrolytes disturbances [ Time Frame: baseline, 1 week, 4 weeks, 8 weeks and 12 weeks ]
    Plain ECG will be performed at the specified time intervals to detect asymptomatic non-ventricular arrhythmias (atrial fibrillation, atrial flutter, atrial premature beats, etc.) The venous blood will be drawn at the specified time intervals to follow closely after potassium levels (for timely detection of salbutamol induced hypokalemia and to correct accordingly), as well to monitor sodium levels as a prognostic and clinical marker of heart failure exacerbation

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Ambulatory Patients with a diagnosis of ischemic and non-ischemic cardiomyopathy with a measured EF <35%, class III as defined by the NYHA with ICD and who receive optimal pharmacological therapy.

Exclusion Criteria:

  • Heart Failure class I, II, IV
  • atrial fibrillation
  • any significant valvular disease
  • chronic obstructive pulmonary disease who treated with inhaled β2 agonist
  • significant kidney disease with eGFR <30%
  • severe uncontrolled electrolyte abnormalities
  • prior allergic reaction to Salbutamol
  • Pregnancy and nursing women

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 identifier (NCT number): NCT01447069

Contact: Zaza Iakobishvili, MD 972-3-937100
Contact: Tuvia Ben Gal, MD 972-3-6930

Rabin medical center Not yet recruiting
Petah Tikva, Israel, 49100
Contact: Zaza Iakobishvili, MD    972-3-9377100   
Contact: Tuvia Ben Gal, MD    972-3-9376930   
Principal Investigator: Zaza Iakobishvili, MD, PhD         
Principal Investigator: Tuvia Ben Gal, MD         
Sponsors and Collaborators
Rabin Medical Center

Responsible Party: Rabin Medical Center Identifier: NCT01447069     History of Changes
Other Study ID Numbers: BTA-HF-01
First Posted: October 5, 2011    Key Record Dates
Last Update Posted: October 5, 2011
Last Verified: August 2011

Keywords provided by Rabin Medical Center:
heart failure stage 3
beta 2 agonist
N-terminal pro-brain natriuretic peptide
ejection fraction <35%

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Tocolytic Agents
Reproductive Control Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action