Coronary Artery BypassDROP-BBNCT05414331
WithDRawal Impact Of Postoperative Beta-Blocker
A study testing Discontinuing all beta-blocker in people with Coronary Artery Bypass, run by Yale University at 1 site in United States.
Trial summary
The investigators will evaluate the impact of withdrawing beta-blocker medication after coronary artery bypass surgery with this randomized controlled trial. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Bypass
- What is being tested?
- Discontinuing all beta-blocker
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Nov 2022to 30 May 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants who underwent coronary artery bypass graft(CABG) surgery at Yale New Haven Hospital who presented to 1-month postoperative visit
- ejection fraction >50%, and in sinus rhythm at the time of hospital discharge or enrollment.
Who cannot join
- those who underwent combined valve + CABG surgery or aorta + CABG surgery.
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale New Haven Hospital
New Haven, Connecticut, 06511
About this study
The investigators will evaluate the impact of withdrawing beta-blocker medication after coronary artery bypass surgery with this randomized controlled trial.
Read the detailed description
Aim 1: The primary aim is to evaluate the impact of withdrawing BB on exercise capacity (peak oxygen consumption, VO2 max) in patients who underwent CABG. The investigators hypothesize that withdrawing BB 1 month after CABG will improve exercise capacity 2 months after CABG.
Aim 2: The secondary objectives are to evaluate the impact of withdrawing BB on a MACCE (major adverse cardiac and cerebrovascular event) and fatigue-related symptoms in patients who underwent CABG. The investigators hypothesize that withdrawing BB after CABG for 1 year will be non-inferior to continuing BB in terms of MACCE incidence.
- Conditions
- Coronary Artery Bypass
- Being tested
- Discontinuing all beta-blocker
- Keywords
- beta-blocker
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Discontinuing all beta-blockerOther
All beta-blockers will be stopped 2 months after CABG
| Study group | Role | What they receive |
|---|---|---|
| Continuation of beta-blocker regimen | No intervention | Participants will continue with current standard of care on current beta-blocker regimen |
| Withdrawing of beta-blockers | Experimental | Discontinuation of all BB, and medication changes will be made at the 1-month clinic visit. A cardiopulmonary exercise test (CPET) will be performed 1 month after the randomization (2 months after CABG). Receives: Other: Discontinuing all beta-blocker |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak oxygen consumption (VO2 max) to measure cardiorespiratory fitness
Peak oxygen measured in ml/kg/min consumption will be measured on CPET 1 month after randomization and be compared controls. This is an important measure of exercise capacity, which has been shown to decrease in other population when on beta-blocker. The higher the measure, the better with measures greater than 12.3 ml/kg/min as positive.
Measured: 1 month
Secondary outcomes (6)
Adherence to medication and adjudication of endpoint
Phone follow-ups at 3 months after CABG to ensure medication adherence and to adjudicate whether the endpoint had occurred
Measured: 3 months
Adherence to medication and adjudication of endpoint
Phone follow-ups at 6 months after CABG to ensure medication adherence and to adjudicate whether the endpoint had occurred
Measured: 6 months
Adherence to medication and adjudication of endpoint
Phone follow-ups at 12 months after CABG to ensure medication adherence and to adjudicate whether the endpoint had occurred
Measured: 12 months
Change in activity level measured using the Veterans Specific Activity Questionnaire(VSAQ)
VSAQ, a 10-item self reported questionnaire will be used to assess activity levels. Participants choose which item best describes their condition best. Items range from 1(low activity) to 13(higher activity). The higher the score, the more active.
Measured: baseline and 3 months
Change in fatigue measured using the Fatigue Assessment Scale (FAS)
The FAS is a self reported 10-item general fatigue questionnaire to assess fatigue. Five questions reflect physical fatigue and 5 questions (questions 3 and 6-9) mental fatigue. The total score ranges from 10 to 50. A total FAS score < 22 indicates no fatigue, a score ≥ 22 indicates fatigue.
Measured: baseline and 3 months
Change in vertigo symptoms measured using the Vertigo Symptom Scale-short form
The 15-item short form self report Vertigo Symptom Scale will be used to assess symptoms: 8 items relating to vertigo-balance, and 7 items relating to autonomic-anxiety symptoms. Each item is scored on a 5-point scale (range 0-4) and the total scale score ranges 0-60 with higher scores indicating more severe problems. Severe dizziness indicated by a score of ≥ 12 points .
Measured: baseline and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2022
- Study start4 Nov 2022
- Primary completion2 May 2024
- Study completion30 May 2024
Why it stopped: The study was terminated as both investigators left the institution.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery BypassStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Aim 1: The investigators will enroll patients with preserved EF (EF ≥50%) who underwent isolated elective or non-elective CABG at Yale New Haven Hospital (YNHH). Blocked randomization will be applied to ensure an equal sample size. Patients will be randomized to 1) continuation of the current BB regimen and 2) discontinuation of all BB, and medication changes will be made at the 1-month clinic visit. A cardiopulmonary exercise test (CPET) will be performed 1 month after the randomization (2 months after CABG). Aim 2: Patients will be randomized at a 1-month postoperative visit, and the outcome will be adjudicated at 12 months since CABG. The safety endpoint is all-cause death, myocardial infarction, stroke, or repeat revascularization at 12 months. The investigators will measure patient-reported outcome on 1) 10-item activity level (VSAQ), 2) Fatigue Assessment Scale. 3) 15-item Vertigo Symptom Scale at the time of enrollment and 3 months.
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- Glenn Memorial Fund
- Responsible party
- Sponsor
- Investigators
- Arnar Geirsson, MD, Principal investigator, Yale UniversityMakoto Mori, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05414331
- Sponsor's protocol ID
- 2000032771
- Acronym
- DROP-BB
- Status last verified
- Apr 2025
- First submitted
- 7 Jun 2022
- Last updated
- 6 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- WithDRawal Impact Of Postoperative Beta-Blocker
- ClinicalTrials.gov ID
- NCT05414331
- Acronym / sponsor ID
- DROP-BB / 2000032771
- Conditions
- Coronary Artery Bypass
- Keywords
- beta-blocker
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated as both investigators left the institution.
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- Glenn Memorial Fund
- Study start
- 4 Nov 2022 (actual)
- Primary completion
- 2 May 2024 (actual)
- Study completion
- 30 May 2024 (actual)
- First posted
- 10 Jun 2022 (actual)
- 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 investigators will evaluate the impact of withdrawing beta-blocker medication after coronary artery bypass surgery with this randomized controlled trial.
Detailed description
Aim 1: The primary aim is to evaluate the impact of withdrawing BB on exercise capacity (peak oxygen consumption, VO2 max) in patients who underwent CABG. The investigators hypothesize that withdrawing BB 1 month after CABG will improve exercise capacity 2 months after CABG.
Aim 2: The secondary objectives are to evaluate the impact of withdrawing BB on a MACCE (major adverse cardiac and cerebrovascular event) and fatigue-related symptoms in patients who underwent CABG. The investigators hypothesize that withdrawing BB after CABG for 1 year will be non-inferior to continuing BB in terms of MACCE incidence.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Aim 1: The investigators will enroll patients with preserved EF (EF ≥50%) who underwent isolated elective or non-elective CABG at Yale New Haven Hospital (YNHH). Blocked randomization will be applied to ensure an equal sample size. Patients will be randomized to 1) continuation of the current BB regimen and 2) discontinuation of all BB, and medication changes will be made at the 1-month clinic visit. A cardiopulmonary exercise test (CPET) will be performed 1 month after the randomization (2 months after CABG). Aim 2: Patients will be randomized at a 1-month postoperative visit, and the outcome will be adjudicated at 12 months since CABG. The safety endpoint is all-cause death, myocardial infarction, stroke, or repeat revascularization at 12 months. The investigators will measure patient-reported outcome on 1) 10-item activity level (VSAQ), 2) Fatigue Assessment Scale. 3) 15-item Vertigo Symptom Scale at the time of enrollment and 3 months.
| Arm | Type | Receives |
|---|---|---|
| Continuation of beta-blocker regimen | No intervention | –Participants will continue with current standard of care on current beta-blocker regimen |
| Withdrawing of beta-blockers | Experimental | Other: Discontinuing all beta-blockerDiscontinuation of all BB, and medication changes will be made at the 1-month clinic visit. A cardiopulmonary exercise test (CPET) will be performed 1 month after the randomization (2 months after CABG). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Participants who underwent coronary artery bypass graft(CABG) surgery at Yale New Haven Hospital who presented to 1-month postoperative visit
- ejection fraction >50%, and in sinus rhythm at the time of hospital discharge or enrollment.
Key exclusion criteria (1 listed)
- those who underwent combined valve + CABG surgery or aorta + CABG surgery.
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 |
|---|---|---|
| Discontinuing all beta-blockerAll beta-blockers will be stopped 2 months after CABG | Other | Withdrawing of beta-blockers |
Primary outcome
Peak oxygen consumption (VO2 max) to measure cardiorespiratory fitness
Time frame: 1 month
Peak oxygen measured in ml/kg/min consumption will be measured on CPET 1 month after randomization and be compared controls. This is an important measure of exercise capacity, which has been shown to decrease in other population when on beta-blocker. The higher the measure, the better with measures greater than 12.3 ml/kg/min as positive.
6 secondary outcomes
Adherence to medication and adjudication of endpoint
Time frame: 3 months
Adherence to medication and adjudication of endpoint
Time frame: 6 months
Adherence to medication and adjudication of endpoint
Time frame: 12 months
Change in activity level measured using the Veterans Specific Activity Questionnaire(VSAQ)
Time frame: baseline and 3 months
Change in fatigue measured using the Fatigue Assessment Scale (FAS)
Time frame: baseline and 3 months
Change in vertigo symptoms measured using the Vertigo Symptom Scale-short form
Time frame: baseline and 3 months
Results and safety
The study was stopped early (reason given: The study was terminated as both investigators left the institution.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2025.
- Individual participant dataSharing planned: No
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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.
Arnar Geirsson, MD principal investigator
Yale University
Makoto Mori, MD principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Discontinuing all beta-blocker in people with Coronary Artery Bypass, run by Yale University at 1 site in United States.
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 2 inclusion and 1 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: stopped early, as of the sponsor's last update on 6 Apr 2025. 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 United States. 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?
The study was stopped early (reason given: The study was terminated as both investigators left the institution.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak oxygen consumption (VO2 max) to measure cardiorespiratory fitness (time frame: 1 month). 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 6 Apr 2025.