Use of Beta-agonists in Stable Severe Congestive Heart Failure

Heart Failure Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01447069
• Other study ID #: BTA-HF-01
• Status: Not yet recruiting
• Phase: N/A
• First received: September 25, 2011
• Last updated: October 2, 2011
• Start date: October 2011
• Est. completion date: March 2012

Study information

• Verified date: August 2011
• Source: Rabin Medical Center
• Contact: Zaza Iakobishvili, MD
• Phone: 972-3-937100
• Email: zazai[@]clalit.org.il
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 ß2 agonist

• significant kidney disease with eGFR <30%

• severe uncontrolled electrolyte abnormalities

• prior allergic reaction to Salbutamol

• Pregnancy and nursing women

Study Design

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

Related Conditions & MeSH terms

• Cardiomyopathies
• Heart Failure
• Ischemic Cardiomyopathy
• Non-ischemic Cardiomyopathy

Intervention

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

Locations

Country	Name	City	State
Israel	Rabin medical center	Petah Tikva

Sponsors (1)

Lead Sponsor	Collaborator
Rabin Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in plasma level of N-terminal pro-BNP at twelve weeks relative to baseline pro-BNP.		12 weeks from baseline pro-BNP assessment	No
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	No
Secondary	Minnesota Living with Heart Failure Questionnaire changes	repeat Minnesota Living with Heart Failure Questionnaire assessment	12 weeks after baseline assessment	Yes
Secondary	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	Yes