Minocycline + Amiodarone for Atrial Fibrillation

(MINA Trial)

Recruiting at 1 trial location

Overseen By Abdallah Alameddine, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Baystate Medical Center

Must not be taking: Immunosuppressants, Corticosteroids, Estrogen

Disqualifiers: Atrial fibrillation, Hepatic dysfunction, Renal dysfunction, Thyrotoxicosis, COPD, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 5

Duration: 2 weeks

60 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you are taking immunosuppressants, long-term oral corticosteroids, or estrogen replacement, you may not be eligible to participate.

What data supports the effectiveness of the drug combination Minocycline and Amiodarone for treating atrial fibrillation?

Amiodarone is a powerful drug used to treat atrial fibrillation by maintaining a normal heart rhythm after it has been restored. It is more effective than some other drugs like sotalol or propafenone for this purpose. However, it can interact with other medications and has potential side effects, so careful monitoring is necessary. ^{1 2 3 4 5}

Is the combination of Minocycline and Amiodarone generally safe for humans?

Minocycline, used for various conditions, can cause serious side effects like autoimmune disorders and hypersensitivity reactions, though these are rare. It's important for doctors to monitor for these effects during treatment. ^{6 7 8 9 10}

What makes the combination of Minocycline and Amiodarone unique for treating atrial fibrillation?

The combination of Minocycline and Amiodarone for atrial fibrillation is unique because it pairs an antibiotic (Minocycline) with an antiarrhythmic drug (Amiodarone), which is not a common approach for this condition. Amiodarone is known for its effectiveness in controlling heart rhythm, but combining it with Minocycline could offer a novel mechanism or benefit that is not yet fully understood in the context of atrial fibrillation. ^{1 2 11 12 13}

What is the purpose of this trial?

. New- onset postoperative atrial fibrillation (POAF) is a common complication after cardiac surgery and its occurrence increases with age. POAF can result in clinically significant morbidity and mortality. The national trend in the US is that the population older than 65 years is increasing, making healthcare expenditure related to POAF to be a major burden on health care system. Effective treatment of POAF is imperative in ensuring quality of care and reduction of costs. In 2021 there is a projected total of 377,763 cardiovascular surgeries in the US alone with approximately half of which will have POAF with longer postoperative length of stay (+3.9 days) and higher discharge costs (+$13,993) than no-POAF patients (Reference: Ann Thorac Surg. 2015 Jan;99(1):109-14). Amiodarone, the currently used therapy, is often insufficient to prevent POAF and has multiple side-effects. In this study, we expect to improve the incidence of POAF by using a common acne drug (Minocycline) that is safe and that could be incorporated in clinical care of this disease.

Research Team

Abdallah k Alameddine, MD

Principal Investigator

Baystate Medical Center

Eligibility Criteria

This trial is for adults over 18 who've had non-congenital cardiac surgery and can use an iPhone to download ECGs. It's not for those with recent cancer, thyroid issues, current or past atrial fibrillation, severe lung disease, liver/kidney dysfunction, inflammatory diseases, on certain medications like immunosuppressants or steroids, pregnant women, or with a history of substance abuse.

Inclusion Criteria

You must have an iPhone and be able to download ECGs onto it.

I have had heart surgery, including bypass or valve repair/replacement.

I have had heart surgery, such as bypass or valve repair.

Exclusion Criteria

I have liver or kidney problems.

I have a condition like lupus, severe arthritis, thyroiditis, or inflammatory bowel disease.

I am on long-term steroids, immunosuppressants, or estrogen replacement.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive intravenous minocycline combined with oral amiodarone or oral amiodarone alone for prevention of POAF

2 weeks

Daily visits for 5 days, then follow-up visits

Follow-up

Participants are monitored for safety and effectiveness after treatment, including telemetry, Holter monitoring, or daily wireless ECG sensors

6 weeks

Treatment Details

Interventions

• Amiodarone
• Minocycline

Trial Overview The study tests if adding Minocycline to Amiodarone reduces the risk of developing atrial fibrillation after heart surgery more effectively than using Amiodarone alone. The goal is to improve patient outcomes and reduce healthcare costs associated with this common post-surgery complication.

Participant Groups

Group I: minocycline Experimental Treatment 2 Interventions

intravenous minocycline 100 mg daily x 5 days starting intra-operatively combined with oral amiodarone (400 mg twice daily for 7 days, then 200 mg twice daily for the next 7 days

Group II: Amiodarone Experimental Treatment 1 Intervention

oral amiodarone

Who Is Running the Clinical Trial?

Baystate Medical Center

Lead Sponsor

Trials

67

Recruited

44,500+

References

1. United States pubmed.ncbi.nlm.nih.gov

New antiarrhythmic agents: amiodarone, aprindine, disopyramide, ethmozin, mexiletine, tocainide, verapamil. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Drug interactions with amiodarone. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Amiodarone: guidelines for use and monitoring. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Pharmacologic management of atrial fibrillation: established and emerging options. [2014]

5. New Zealand pubmed.ncbi.nlm.nih.gov

New antiarrhythmic drugs. [2018]

6. Switzerland pubmed.ncbi.nlm.nih.gov

A Review of Systemic Minocycline Side Effects and Topical Minocycline as a Safer Alternative for Treating Acne and Rosacea. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Minocycline-induced dermatomyositis. [2013]

8. France pubmed.ncbi.nlm.nih.gov

[Minocycline]. [2013]

9. United States pubmed.ncbi.nlm.nih.gov

N,N-dimethylglycyl-amido derivative of minocycline and 6-demethyl-6-desoxytetracycline, two new glycylcyclines highly effective against tetracycline-resistant gram-positive cocci. [2021]

10. Netherlands pubmed.ncbi.nlm.nih.gov

[Side effects of minocycline in the treatment of acne vulgaris]. [2013]

11. United States pubmed.ncbi.nlm.nih.gov

High-performance liquid chromatographic determination of 12 antiarrhythmic drugs in plasma using solid-phase column extraction. [2019]

12. Spain pubmed.ncbi.nlm.nih.gov

Dramatic reduction of ventricular tachycardia burden after dronedarone plus mexiletine treatment in a patient refractory to hybrid ablation. [2021]

13. England pubmed.ncbi.nlm.nih.gov

Lack of interaction between amiodarone and mexiletine in cardiac arrhythmia patients. [2019]