Use of Beta-agonists in Stable Severe Congestive Heart Failure

Clalit Health Services

Status: Unknown

Conditions: Heart Failure; Non-ischemic Cardiomyopathy; Ischemic Cardiomyopathy

Treatments: Drug: Salbutamol

Study type: Interventional

Funder types: Other

Identifiers

NCT01447069

BTA-HF-01

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Salbutamol

Active Comparator group

Description:

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

Treatment:

Drug: Salbutamol

control

No Intervention group

Description:

The patients in the control group will continue with their regular optimal medical therapy without any intervention.