Use of Beta-agonists in Stable Severe Congestive Heart Failure

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.

Study Overview

• Status: Unknown
• Conditions: Heart Failure; Ischemic Cardiomyopathy; Non-ischemic Cardiomyopathy
• Intervention / Treatment: Drug: Salbutamol

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Petah Tikva, Israel, 49100
    • Rabin Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Changes in plasma level of N-terminal pro-BNP at twelve weeks relative to baseline pro-BNP.	12 weeks from baseline pro-BNP assessment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse cardiovascular event: Death, ICD discharge, significant ventricular arrhythmias and hospitalization due to heart failure exacerbation	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.	12 weeks after baseline assessment
NYHA class changes	We will assess NYHA functional class at baseline and after 12 weeks from the beginning of study medication.	12 weeks after baseline assessment
Echocardiography parameters changes	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	12 weeks after baseline assessment
Minnesota Living with Heart Failure Questionnaire changes	repeat Minnesota Living with Heart Failure Questionnaire assessment	12 weeks after baseline assessment
Non-ventricular arrhythmias and electrolytes disturbances	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	baseline, 1 week, 4 weeks, 8 weeks and 12 weeks

Collaborators and Investigators

• Sponsor: Rabin Medical Center

Study record dates

Study Major Dates

• Study Start: October 1, 2011
• Primary Completion (Anticipated): March 1, 2012
• Study Completion (Anticipated): March 1, 2012

Study Registration Dates

• First Submitted: September 25, 2011
• First Submitted That Met QC Criteria: October 2, 2011
• First Posted (Estimate): October 5, 2011

Study Record Updates

• Last Update Posted (Estimate): October 5, 2011
• Last Update Submitted That Met QC Criteria: October 2, 2011
• Last Verified: August 1, 2011

More Information

Terms related to this study

• Keywords: heart failure stage 3; beta 2 agonist; N-terminal pro-brain natriuretic peptide; ejection fraction <35%
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure; Cardiomyopathies; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Adrenergic Agonists; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Reproductive Control Agents; Adrenergic beta-2 Receptor Agonists; Adrenergic beta-Agonists; Tocolytic Agents; Albuterol
• Other Study ID Numbers: BTA-HF-01