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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Salbutamol | Active Comparator | The patients in the study groups will receive the selective β2 agonist, Salbutamol, in addition to their ongoing optimal heart failure therapy. |
|
| control | No Intervention | The patients in the control group will continue with their regular optimal medical therapy without any intervention. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Salbutamol | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in plasma level of N-terminal pro-BNP at twelve weeks relative to baseline pro-BNP. | 12 weeks from baseline pro-BNP assessment |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zaza Iakobishvili, MD | Contact | 972-3-937100 | zazai@clalit.org.il | |
| Tuvia Ben Gal, MD | Contact | 972-3-6930 | bengalt@clalit.org.il |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rabin medical center | Petah Tikva | 49100 | Israel |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000420 | Albuterol |
| ID | Term |
|---|---|
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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| 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 |
| 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 |
| Minnesota Living with Heart Failure Questionnaire changes | repeat Minnesota Living with Heart Failure Questionnaire assessment | 12 weeks after baseline 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 | baseline, 1 week, 4 weeks, 8 weeks and 12 weeks |
| D000588 |
| Amines |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |