Use of Beta-agonists in Stable Severe Congestive Heart Failure

Not Applicable

• Conditions: Ischemic Cardiomyopathy; Non-ischemic Cardiomyopathy; Heart Failure
• Interventions: Drug: Salbutamol

• Registration Number: NCT01447069
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2011-08
• Study First Submitted: 2011-09-25
• Study Start: 2011-10
• Study First Submitted QC: 2011-10-02
• Last Update Submitted: 2011-10-02
• Study First Posted: 2011-10-05
• Last Update Posted: 2011-10-05
• Primary Completion: 2012-03
• Study Completion: 2012-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Salbutamol	Salbutamol	The patients in the study groups will receive the selective β2 agonist, Salbutamol, in addition to their ongoing optimal heart failure therapy.

Primary Outcome Measures

Name	Time	Method
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

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

Trial Locations

Locations (1)

Rabin medical center; 🇮🇱 Petah Tikva, Israel