Post-operative Atrial Fibrillation (POAF)Phase 1/2NCT03793465
Pilot-Tart Cherry, Mitral Transcriptome, and POAF Incidence
A Phase 1/2 study testing tart cherry concentrate in people with Post-operative Atrial Fibrillation (POAF), run by University of Michigan at 1 site in United States.
Trial summary
Assess impact of Tart Cherry Concentrate in cardiac surgical patients on POAF and related clinical and economic outcomes. Measure inflammation gene transcripts in cardiac tissue. Read more about this study
- Who is it for?
- Ages 50 to 79 years
- Conditions the study is for
- Post-operative Atrial Fibrillation (POAF)
- What is being tested?
- tart cherry concentrate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Feb 2019to Jan 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
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 50 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and female patients (age 50-79) at the Mitral Valve Clinic/CVC undergoing elective cardiac surgery for mitral valve repair without the Cox MAZE procedure (MVR patients also undergoing CABG and/or tricuspid valve repair are also eligible)
- In sinus rhythm (no pre-operative atrial fibrillation, no hx of AF)
Who cannot join
- Age ≥ 80 years
- Diagnosed pre-operative chronic or paroxysmal AF
- Prior ablation procedure for AF
- Previous cardiac surgery
- Implanted pacemaker
- Active smoker
Show all 13Show fewer
- Comorbidities such as congenital or cardiac re-operation
- Use of antiarrhythmic agents
- Active inflammatory or infectious disease or malignancy
- Diagnosed autoimmune disease
- Corticosteroid or other immunomodulatory or immunosuppressive medication
- Known sensitivity to sorbitol
- Known gastric sensitivity to acidic juices like orange juice
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot-Tart Cherry, Mitral Transcriptome and POAF Incidence
Assess impact of Tart Cherry Concentrate in cardiac surgical patients on POAF and related clinical and economic outcomes. Measure inflammation gene transcripts in cardiac tissue.
- Being tested
- tart cherry concentrate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tart cherry concentrateDietary supplement
Consume 2 servings (1 ounce or 2 tablespoon/serving) per day for three days before cardiac surgery
| Study group | Role | What they receive |
|---|---|---|
| Tart Cherry Concentrate | Experimental | Single arm, open-label design. Commercial Montmorency tart cherry juice concentrate. Servings (1 ounce or 2 tablespoon/serving) per day for three days Receives: Dietary Supplement: tart cherry concentrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient-reported tolerability score
Patients will complete a brief questionnaire regarding gastrointestinal status, using the Bristol Stool Form Scale
Measured: One week
Efficacy as measured by total number of days in hospital within 60 days of surgery
Total number of days in hospital within 60 days of the index surgery
Measured: 60 days
Efficacy as measured by altered (+/- 0.5 fold change) atrial transcript expression (mRNA) related to NFκB activation
Altered (+/- 0.5 fold change) atrial transcript expression (mRNA) related to NFκB activation
Measured: 30 days
Secondary outcomes (13)
Time to conversion to normal sinus rhythm
Perioperative time to conversion to normal sinus rhythm
Measured: 30 days
Heart rhythm at hospital discharge
Heart rhythm at hospital discharge
Measured: 30 days
Heart rhythm at 30 days
Heart rhythm at 30 days
Measured: 30 days
Need for permanent pacemaker within 30 days of surgery
Need for permanent pacemaker within 30 days of surgery
Measured: 30 days
Cerebrovascular thromboembolism [stroke, TIA]
Incidences (yes/no, total number) of Cerebrovascular thromboembolism [stroke, TIA]
Measured: 30 days
Non-cerebrovascular thromboembolism
Incidences (yes/no, total number) of Non-cerebrovascular thromboembolism
Measured: 30 days
Bleeding
Incidences (yes/no, total number) of Bleeding
Measured: 30 days
Cerebrovascular events
Incidences (yes/no, total number) of Cerebrovascular events
Measured: 30 days
Incidences of postoperative clinical events
Incidences (yes/no, total number) of Non-cerebrovascular events
Measured: 30 days
Length of Hospital Stay
LOS [Index hospitalization]
Measured: 60 days
Number of Re-hospitalization and ED visits
Number of Re-hospitalization and ED visits
Measured: 60 days
Number of Outpatient Interventions
Number of Outpatient interventions
Measured: 60 days
Total Costs for Hospital stay
Costs [incident hospital stay]
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2019
- Study start8 Feb 2019
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-operative Atrial Fibrillation (POAF)Studies of the same condition, open and under way.
- More trials run by University of MichiganThe 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 1/2
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single arm, open-label design. Commercial Montmorency tart cherry juice concentrate. Consumption - 2 servings (1 ounce or 2 tablespoon/serving) per day for three days before cardiac surgery
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- Cherry Marketing Institute
- Responsible party
- Principal investigator, Steven Bolling, University of Michigan
- Investigators
- Steven F Bolling, MD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03793465
- Sponsor's protocol ID
- HUM00145800
- Status last verified
- Feb 2026
- First submitted
- 2 Jan 2019
- Last updated
- 5 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot-Tart Cherry, Mitral Transcriptome and POAF Incidence
- ClinicalTrials.gov ID
- NCT03793465
- Acronym / sponsor ID
- HUM00145800
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- Cherry Marketing Institute
- Study start
- 8 Feb 2019 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 4 Jan 2019 (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.
Assess impact of Tart Cherry Concentrate in cardiac surgical patients on POAF and related clinical and economic outcomes. Measure inflammation gene transcripts in cardiac tissue.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single arm, open-label design. Commercial Montmorency tart cherry juice concentrate. Consumption - 2 servings (1 ounce or 2 tablespoon/serving) per day for three days before cardiac surgery
| Arm | Type | Receives |
|---|---|---|
| Tart Cherry Concentrate | Experimental | Dietary Supplement: tart cherry concentrateSingle arm, open-label design. Commercial Montmorency tart cherry juice concentrate. Servings (1 ounce or 2 tablespoon/serving) per day for three days |
Who may qualify
- Ages
- 50 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Males and female patients (age 50-79) at the Mitral Valve Clinic/CVC undergoing elective cardiac surgery for mitral valve repair without the Cox MAZE procedure (MVR patients also undergoing CABG and/or tricuspid valve repair are also eligible)
- In sinus rhythm (no pre-operative atrial fibrillation, no hx of AF)
Key exclusion criteria (13 listed)
- Age ≥ 80 years
- Diagnosed pre-operative chronic or paroxysmal AF
- Prior ablation procedure for AF
- Previous cardiac surgery
- Implanted pacemaker
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 |
|---|---|---|
| tart cherry concentrateConsume 2 servings (1 ounce or 2 tablespoon/serving) per day for three days before cardiac surgery | Dietary supplement | Tart Cherry Concentrate |
Primary outcome
Patient-reported tolerability score
Time frame: One week
Patients will complete a brief questionnaire regarding gastrointestinal status, using the Bristol Stool Form Scale
Efficacy as measured by total number of days in hospital within 60 days of surgery
Time frame: 60 days
Total number of days in hospital within 60 days of the index surgery
Efficacy as measured by altered (+/- 0.5 fold change) atrial transcript expression (mRNA) related to NFκB activation
Time frame: 30 days
Altered (+/- 0.5 fold change) atrial transcript expression (mRNA) related to NFκB activation
13 secondary outcomes
Time to conversion to normal sinus rhythm
Time frame: 30 days
Heart rhythm at hospital discharge
Time frame: 30 days
Heart rhythm at 30 days
Time frame: 30 days
Need for permanent pacemaker within 30 days of surgery
Time frame: 30 days
Cerebrovascular thromboembolism [stroke, TIA]
Time frame: 30 days
Non-cerebrovascular thromboembolism
Time frame: 30 days
Bleeding
Time frame: 30 days
Cerebrovascular events
Time frame: 30 days
Incidences of postoperative clinical events
Time frame: 30 days
Length of Hospital Stay
Time frame: 60 days
Number of Re-hospitalization and ED visits
Time frame: 60 days
Number of Outpatient Interventions
Time frame: 60 days
Total Costs for Hospital stay
Time frame: 60 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2026.
- Individual participant dataSharing planned: No
Related trials for Post-operative Atrial Fibrillation (POAF)
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The DefiPace Study
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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.
Steven F Bolling, MD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing tart cherry concentrate in people with Post-operative Atrial Fibrillation (POAF), run by University of Michigan 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 13 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: under way, not looking for participants, as of the sponsor's last update on 5 Feb 2026. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Patient-reported tolerability score (time frame: One week). The study lists 3 primary outcomes in all. 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 Feb 2026.