Use of Beta-agonists in Stable Severe Congestive Heart Failure
Recruitment status was Not yet recruiting
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
- 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 ] [ Designated as safety issue: No ]
- Adverse cardiovascular event: Death, ICD discharge, significant ventricular arrhythmias and hospitalization due to heart failure exacerbation [ Time Frame: 12 weeks after baseline assessment ] [ Designated as safety issue: Yes ]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 [ Time Frame: 12 weeks after baseline assessment ] [ Designated as safety issue: Yes ]We will assess NYHA functional class at baseline and after 12 weeks from the beginning of study medication.
- Echocardiography parameters changes [ Time Frame: 12 weeks after baseline assessment ] [ Designated as safety issue: No ]
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 [ Time Frame: 12 weeks after baseline assessment ] [ Designated as safety issue: Yes ]repeat Minnesota Living with Heart Failure Questionnaire assessment
- Non-ventricular arrhythmias and electrolytes disturbances [ Time Frame: baseline, 1 week, 4 weeks, 8 weeks and 12 weeks ] [ Designated as safety issue: Yes ]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
|Study Start Date:||October 2011|
|Estimated Study Completion Date:||March 2012|
|Estimated Primary Completion Date:||March 2012 (Final data collection date for primary outcome measure)|
Active Comparator: Salbutamol
The patients in the study groups will receive the selective β2 agonist, Salbutamol, in addition to their ongoing optimal heart failure therapy.
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
No Intervention: control
The patients in the control group will continue with their regular optimal medical therapy without any intervention.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01447069
|Contact: Zaza Iakobishvili, MDfirstname.lastname@example.org|
|Contact: Tuvia Ben Gal, MDemail@example.com|
|Rabin medical center||Not yet recruiting|
|Petah Tikva, Israel, 49100|
|Contact: Zaza Iakobishvili, MD 972-3-9377100 firstname.lastname@example.org|
|Contact: Tuvia Ben Gal, MD 972-3-9376930 email@example.com|
|Principal Investigator: Zaza Iakobishvili, MD, PhD|
|Principal Investigator: Tuvia Ben Gal, MD|