Using Mirabegron to Control Arrhythmia-1 (MACH-1)
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
Objectives:
Primary objective: To evaluate if mirabegron can reduce the VT burden. Secondary objective: To test the hypothesis that mirabegron can reduce the average skin sympathetic nerve activity (aSKNA).
Endpoints: The primary endpoint is the burden of VT detected by ICD. The secondary endpoint is the average skin sympathetic nerve activity, symptoms, and quality of life (QOL) questionnaires.
Study Population: This is a pilot study in patients with an ICD and, on average, > 2 episodes of VT per month over the past 2 months despite guideline-recommended medical therapy (GRMT).
Phase: Phase 2.
Description of Sites/Facilities Enrolling Participants: The investigators will enroll patients in the cardiac device clinic at the Smidt Heart Institute, Cedars-Sinai Medical Center. Dr. Ashkan Ehdaie (co-investigator) directs the clinic, which routinely follows up on patients with ICDs.
Description of Study Intervention: The investigators will give the patients 50 mg/day of mirabegron orally for three months.
Study Duration: One-year.
Participant Duration: Approximately three months. The primary endpoint takes 2 months to complete. The investigators will call the patient at 3 months to determine if there are any complications. The patient will then exit the study.
Studietyp
Inskrivning (Beräknad)
Fas
- Fas 2
Kontakter och platser
Studiekontakt
- Namn: Peng-Sheng Chen, MD
- Telefonnummer: 310-967-2707
- E-post: peng-sheng.chen@csmc.edu
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Beskrivning
Inclusion Criteria:
In order to be eligible to participate in this study, an individual must meet all the following criteria:
- Provision of signed and dated informed consent form.
- Age > 18 years old.
Documented VT on ICD.
- with > 2 episodes of VT per month (on average) over the past 2 months.
- despite guideline-recommended medical therapy (GRMT).
Exclusion Criteria:
An individual who meets any of the following criteria will be excluded from participation in this study:
- Patients who are pacemaker-dependent because the pacing artifacts will complicate skin sympathetic nerve activity (SKNA) analysis.
- Clinically unstable (for example, acute myocardial infarction, decompensated heart failure, undergoing cancer chemotherapy, and other acute illness requiring hospitalization)
- Uncontrolled hypertension (systolic blood pressure ≥180 mm Hg or diastolic blood pressure ≥110 mm Hg, or both)25
- Active thyrotoxicosis
- Any experimental medication concomitantly or within 4 weeks of participation in the study
- Currently participating in a different clinical trial
- Severe renal impairment (CrCl < 30 ml/min)
- Hepatic disease (Child-Pugh Class C)
- Pregnant
- Breastfeeding
- Cannot speak, write, and answer questions in English
- Does not have the capacity to consent
- Severe renal impairment (CrCl < 30 ml/min)
- Hepatic disease (Child-Pugh Class C)
- Pregnant
- Breastfeeding
- Cannot speak, write, and answer questions in English
- Does not have the capacity to consent
- Patients who are known to be allergic to mirabegron or skin patch electrodes
- Patients taking codeine, oxycodone, thioridazine, flecainide, propafenone, and digoxin. (see explanation below)
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: mirabegron
The investigators will give the patients 50 mg/day of mirabegron orally for three months.
|
Mirabegron is a beta-3 agonist approved by FDA to treat overactive bladder.
Our preclinical studies showed that it is antiarrhythmic in the ventricles.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
The primary endpoint is reduction of the burden of VT detected by ICD
Tidsram: 3 months
|
The patients with ICD will record the VT burden.
The investigators will use that number as the primary outcomes measure.
|
3 months
|
Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- STUDY00004239
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
IPD-planbeskrivning
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Studerar en amerikansk FDA-reglerad produktprodukt
produkt tillverkad i och exporterad från U.S.A.
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .