Use of Beta-agonists in Stable Severe Congestive Heart Failure

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2011 by Rabin Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by (Responsible Party):
Rabin Medical Center
ClinicalTrials.gov Identifier:
NCT01447069
First received: September 25, 2011
Last updated: October 2, 2011
Last verified: August 2011
  Purpose

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 Intervention
Ischemic Cardiomyopathy
Non-ischemic Cardiomyopathy
Heart Failure
Drug: Salbutamol

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Rabin Medical Center:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Adverse cardiovascular event: Death, ICD discharge, significant ventricular arrhythmias and hospitalization due to heart failure exacerbation [ Time Frame: 12 weeks after baseline assessment ] [ Designated as safety issue: Yes ]
    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.

  • NYHA class changes [ Time Frame: 12 weeks after baseline assessment ] [ Designated as safety issue: Yes ]
    We will assess NYHA functional class at baseline and after 12 weeks from the beginning of study medication.

  • Echocardiography parameters changes [ Time Frame: 12 weeks after baseline assessment ] [ Designated as safety issue: No ]

    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


  • Minnesota Living with Heart Failure Questionnaire changes [ Time Frame: 12 weeks after baseline assessment ] [ Designated as safety issue: Yes ]
    repeat Minnesota Living with Heart Failure Questionnaire assessment

  • Non-ventricular arrhythmias and electrolytes disturbances [ Time Frame: baseline, 1 week, 4 weeks, 8 weeks and 12 weeks ] [ Designated as safety issue: Yes ]
    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


Estimated Enrollment: 30
Study Start Date: October 2011
Estimated Study Completion Date: March 2012
Estimated Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01447069

Contacts
Contact: Zaza Iakobishvili, MD 972-3-937100 zazai@clalit.org.il
Contact: Tuvia Ben Gal, MD 972-3-6930 bengalt@clalit.org.il

Locations
Israel
Rabin medical center Not yet recruiting
Petah Tikva, Israel, 49100
Contact: Zaza Iakobishvili, MD    972-3-9377100    zazai@clalit.org.il   
Contact: Tuvia Ben Gal, MD    972-3-9376930    bengalt@clalit.org.il   
Principal Investigator: Zaza Iakobishvili, MD, PhD         
Principal Investigator: Tuvia Ben Gal, MD         
Sponsors and Collaborators
Rabin Medical Center
  More Information

No publications provided

Responsible Party: Rabin Medical Center
ClinicalTrials.gov Identifier: NCT01447069     History of Changes
Other Study ID Numbers: BTA-HF-01
Study First Received: September 25, 2011
Last Updated: October 2, 2011
Health Authority: Israel: Ethics Commission

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
Cardiomyopathies
Heart Diseases
Cardiovascular Diseases
Albuterol
Natriuretic Peptide, Brain
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Tocolytic Agents
Reproductive Control Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Natriuretic Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on August 28, 2014