search
Back to results

Use of Beta-agonists in Stable Severe Congestive Heart Failure

Primary Purpose

Ischemic Cardiomyopathy, Non-ischemic Cardiomyopathy, Heart Failure

Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Salbutamol
Sponsored by
Rabin Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ischemic Cardiomyopathy focused on measuring heart failure stage 3, beta 2 agonist, N-terminal pro-brain natriuretic peptide, ejection fraction <35%

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Rabin medical center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Salbutamol

control

Arm Description

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

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

Outcomes

Primary Outcome Measures

Changes in plasma level of N-terminal pro-BNP at twelve weeks relative to baseline pro-BNP.

Secondary Outcome Measures

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.
NYHA class changes
We will assess NYHA functional class at baseline and after 12 weeks from the beginning of study medication.
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
Minnesota Living with Heart Failure Questionnaire changes
repeat Minnesota Living with Heart Failure Questionnaire 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

Full Information

First Posted
September 25, 2011
Last Updated
October 2, 2011
Sponsor
Rabin Medical Center
search

1. Study Identification

Unique Protocol Identification Number
NCT01447069
Brief Title
Use of Beta-agonists in Stable Severe Congestive Heart Failure
Study Type
Interventional

2. Study Status

Record Verification Date
August 2011
Overall Recruitment Status
Unknown status
Study Start Date
October 2011 (undefined)
Primary Completion Date
March 2012 (Anticipated)
Study Completion Date
March 2012 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rabin Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Cardiomyopathy, Non-ischemic Cardiomyopathy, Heart Failure
Keywords
heart failure stage 3, beta 2 agonist, N-terminal pro-brain natriuretic peptide, ejection fraction <35%

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Salbutamol
Arm Type
Active Comparator
Arm Description
The patients in the study groups will receive the selective β2 agonist, Salbutamol, in addition to their ongoing optimal heart failure therapy.
Arm Title
control
Arm Type
No Intervention
Arm Description
The patients in the control group will continue with their regular optimal medical therapy without any intervention.
Intervention Type
Drug
Intervention Name(s)
Salbutamol
Intervention Description
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
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
Adverse cardiovascular event: Death, ICD discharge, significant ventricular arrhythmias and hospitalization due to heart failure exacerbation
Description
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
Title
NYHA class changes
Description
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
Title
Echocardiography parameters changes
Description
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
Title
Minnesota Living with Heart Failure Questionnaire changes
Description
repeat Minnesota Living with Heart Failure Questionnaire assessment
Time Frame
12 weeks after baseline assessment
Title
Non-ventricular arrhythmias and electrolytes disturbances
Description
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
Time Frame
baseline, 1 week, 4 weeks, 8 weeks and 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zaza Iakobishvili, MD
Phone
972-3-937100
Email
zazai@clalit.org.il
First Name & Middle Initial & Last Name or Official Title & Degree
Tuvia Ben Gal, MD
Phone
972-3-6930
Email
bengalt@clalit.org.il
Facility Information:
Facility Name
Rabin medical center
City
Petah Tikva
ZIP/Postal Code
49100
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zaza Iakobishvili, MD
Phone
972-3-9377100
Email
zazai@clalit.org.il
First Name & Middle Initial & Last Name & Degree
Tuvia Ben Gal, MD
Phone
972-3-9376930
Email
bengalt@clalit.org.il
First Name & Middle Initial & Last Name & Degree
Zaza Iakobishvili, MD, PhD
First Name & Middle Initial & Last Name & Degree
Tuvia Ben Gal, MD

12. IPD Sharing Statement

Learn more about this trial

Use of Beta-agonists in Stable Severe Congestive Heart Failure

We'll reach out to this number within 24 hrs