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Blood test may help Fine-Tune heart drug dosing

NCT ID NCT07487714

Disease control Sponsor: Tomsk National Research Medical Center of the Russian Academy of Sciences Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only This study
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether measuring amiodarone levels in the blood helps doctors choose the right dose for people with paroxysmal atrial fibrillation (a type of irregular heartbeat). About 80 adults will receive different daily doses (100, 200, or 400 mg) and be monitored for three months. The goal is to see if this approach reduces the return of atrial fibrillation episodes.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Amiodarone
What this could lead to
If successful, this could show that adjusting amiodarone dose based on blood levels improves control of atrial fibrillation with fewer side effects.
What could go wrong
This is a small, early-phase study (80 participants) and may not prove that blood monitoring is better than standard care. Amiodarone also has known risks like thyroid and lung problems.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 80 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2026

Expected to finish

Aug 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion criteria: 1. The patient must have a documented electrocardiogram (ECG) or 24-hour ECG monitoring for paroxysmal AF. 2. Patient age \>18 years. 3. Signed informed consent for participation in the study. 4. Indications for amiodarone. Exclusion criteria for the study 1. Contraindications to the administration of amiodarone according to the drug's instructions for use 2. Patients with coronary artery disease with confirmed ischemia based on stress tests and the need for revascularization based on coronary angiography and multispiral computed tomography coronary angiography. 3. Patients with resistant arterial hypertension. 4. Planned catheter treatment of atrial fibrillation during the follow up period or early within 3 months postoperative period for catheter treatment of atrial fibrillation. 5. Thrombosis of the heart cavities. 6. Concomitant therapy with psychotropic drugs, antiarrhythmics of class IA and III, antibiotics, antifungal drugs, antimalarial and antiprotozoal drugs, antitumor, antiemetic drugs and drugs affecting gastrointestinal motility, antihistamines; 7. Patients incapacitated due to psychoneurological conditions; 8. Pregnant women or women of childbearing age planning pregnancy during the study.

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Conditions

The condition(s) this trial relates to.

atrial fibrillation paroxysmal atrial fibrillation

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Paroxysmal af Therapeutic drug monitoring (TDM) Treatment decisions

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Kievskaya street 111a Cardiology research institute

    Tomsk, 634012, Russia

More trials for these conditions

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