Ischemic CardiomyopathyNCT01447069
Use of Beta-agonists in Stable Severe Congestive Heart Failure
A study testing Salbutamol in people with Ischemic Cardiomyopathy and Non-ischemic Cardiomyopathy, run by Rabin Medical Center at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Ischemic Cardiomyopathy, Non-ischemic Cardiomyopathy, Heart Failure
- What is being tested?
- Salbutamol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteIsrael
- Study dates
- Oct 2011to Mar 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Israel1 site
Rabin medical center
Petah Tikva, 49100
Zaza Iakobishvili, MD, 972-3-9377100, zazai@clalit.org.il
Tuvia Ben Gal, MD, 972-3-9376930, bengalt@clalit.org.il
About this study
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.
- Being tested
- Salbutamol
- Keywords
- heart failure stage 3, beta 2 agonist, N-terminal pro-brain natriuretic peptide, ejection fraction <35%
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Salbutamol |
| control | No intervention | The patients in the control group will continue with their regular optimal medical therapy without any intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in plasma level of N-terminal pro-BNP at twelve weeks relative to baseline pro-BNP.
Measured: 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
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.
Measured: 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.
Measured: 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
Measured: 12 weeks after baseline assessment
Minnesota Living with Heart Failure Questionnaire changes
repeat Minnesota Living with Heart Failure Questionnaire assessment
Measured: 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
Measured: baseline, 1 week, 4 weeks, 8 weeks and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2011 (estimated)
- Study startOct 2011
- Primary completionMar 2012 (estimated)
- Study completionMar 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic CardiomyopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rabin Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01447069
- Sponsor's protocol ID
- BTA-HF-01
- Status last verified
- Aug 2011
- First submitted
- 25 Sep 2011
- Last updated
- 5 Oct 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Beta-agonists in Stable Severe Congestive Heart Failure
- ClinicalTrials.gov ID
- NCT01447069
- Acronym / sponsor ID
- BTA-HF-01
- Keywords
- heart failure stage 3, beta 2 agonist, N-terminal pro-brain natriuretic peptide, ejection fraction <35%
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Mar 2012 (estimated)
- Study completion
- Mar 2012 (estimated)
- First posted
- 5 Oct 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Salbutamol | Active comparator | Drug: SalbutamolThe 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (8 listed)
- 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%
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SalbutamolThe 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 | Drug | Salbutamol |
Primary outcome
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
5 secondary outcomes
Adverse cardiovascular event: Death, ICD discharge, significant ventricular arrhythmias and hospitalization due to heart failure exacerbation
Time frame: 12 weeks after baseline assessment
NYHA class changes
Time frame: 12 weeks after baseline assessment
Echocardiography parameters changes
Time frame: 12 weeks after baseline assessment
Minnesota Living with Heart Failure Questionnaire changes
Time frame: 12 weeks after baseline assessment
Non-ventricular arrhythmias and electrolytes disturbances
Time frame: baseline, 1 week, 4 weeks, 8 weeks and 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Salbutamol in people with Ischemic Cardiomyopathy and Non-ischemic Cardiomyopathy, run by Rabin Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zaza Iakobishvili, MD (972-3-937100, zazai@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2011.