Use of Beta-agonists in Stable Severe Congestive Heart Failure

Rabin Medical Center30 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Ischemic Cardiomyopathy Non-ischemic Cardiomyopathy Heart Failure

Interventions

SalbutamolDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Rabin medical center

Petah Tikva, Israel

Outcomes

Primary Outcomes

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

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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

Time frame: 12 weeks after baseline assessment

Minnesota Living with Heart Failure Questionnaire changes

repeat Minnesota Living with Heart Failure Questionnaire assessment

Time frame: 12 weeks after baseline assessment

Non-ventricular arrhythmias and electrolytes disturbances

Central Contacts

Zaza Iakobishvili, MD

CONTACT

972-3-937100 zazai@clalit.org.il

Tuvia Ben Gal, MD

CONTACT

972-3-6930 bengalt@clalit.org.il

Data from ClinicalTrials.gov

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