Use of Beta-agonists in Stable Severe Congestive Heart Failure
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2011
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 25, 2011
CompletedStudy Start
First participant enrolled
October 1, 2011
CompletedFirst Posted
Study publicly available on registry
October 5, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2012
CompletedOctober 5, 2011
August 1, 2011
5 months
September 25, 2011
October 2, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Changes in plasma level of N-terminal pro-BNP at twelve weeks relative to baseline pro-BNP.
12 weeks from baseline pro-BNP assessment
Secondary Outcomes (5)
Adverse cardiovascular event: Death, ICD discharge, significant ventricular arrhythmias and hospitalization due to heart failure exacerbation
12 weeks after baseline assessment
NYHA class changes
12 weeks after baseline assessment
Echocardiography parameters changes
12 weeks after baseline assessment
Minnesota Living with Heart Failure Questionnaire changes
12 weeks after baseline assessment
Non-ventricular arrhythmias and electrolytes disturbances
baseline, 1 week, 4 weeks, 8 weeks and 12 weeks
Study Arms (2)
Salbutamol
ACTIVE COMPARATORThe patients in the study groups will receive the selective β2 agonist, Salbutamol, in addition to their ongoing optimal heart failure therapy.
control
NO INTERVENTIONThe patients in the control group will continue with their regular optimal medical therapy without any intervention.
Interventions
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 Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Rabin medical center
Petah Tikva, 49100, Israel
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 25, 2011
First Posted
October 5, 2011
Study Start
October 1, 2011
Primary Completion
March 1, 2012
Study Completion
March 1, 2012
Last Updated
October 5, 2011
Record last verified: 2011-08