Effects of Carvedilol on Suppressing the Premature Ventricular Complex/Ventricular Tachycardia From Outflow Tract

NCT03587558 | Unknown Phase 4 DMC

• 1 other identifier: 2017-07-022
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 11

Brief Summary

Carvedilol is known to be effective in reducing ventricular arrhythmias and mortality in patients with heart failure. It is suggested that one of the mechanisms is its ability to block store overload-induced Calcium release which activates spontaneous calcium release by Ryanodine receptors. Ventricular outflow tract tachyarrhythmia is known to be associated with calcium overload due to activation of Ryanodine receptors. The aim of this study is to evaluate the efficacy of Carvedilol on premature ventricular complex(PVC)/ventricular tachycardia(VT) originating from outflow tract.

Conditions

Ventricular Premature Complexes; Outflow Tract; Carvedilol

Keywords

carvedilol; SOICR; triggered activity; outflow tract PVC/VT

Outcome Measures

Primary Outcomes (1)

• PVC burden

  Percentage of PVC/VT beat out of 24 hour total heart beat in Holter monitoring

  3 months after reaching the maximum tolerated dose

Secondary Outcomes (2)

• Symptom assessment scale

  3 months after reaching the maximum tolerated dose

• Side effect of drugs

  3 months after reaching the maximum tolerated dose

Study Arms (2)

Carvedilol group

EXPERIMENTAL

Patients in this group are taking carvedilol to inhibit outflow tract PVC/VT. Dilatrend® sustained release form of Chong Kun Dang Pharmaceutical will be used (initial dose: 8 mg sustained release form). Outpatient follow-up will be performed every 2 weeks and the dose is increased from the initial dose to a maximal tolerable dose, at the discretion of the investigator.

Drug: Carvedilol

Flecainide group

ACTIVE COMPARATOR

Patients in this group are taking flecainide to inhibit outflow tract PVC/VT. Tambocor® of JW Pharmaceutical will be used. Outpatient follow-up will be performed every 2 weeks and the dose is increased from the initial dose to a maximal tolerable dose, at the discretion of the investigator.

Drug: Flecainide

Interventions

Carvedilol DRUG

Patients in this group are taking carvedilol to inhibit outflow tract PVC/VT.

Also known as: Dilatrend

Carvedilol group

Flecainide DRUG

Patients in this group are taking flecainide to inhibit outflow tract PVC/VT.

Also known as: Tambocor

Flecainide group

Eligibility Criteria

• Age: 19 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with ventricular premature complexes/ventricular tachycardias originating from ventricular outflow tract confirmed on the 12-lead surface ECG
• Patients with PVC burden of 5% or more in 24-hour Holter monitoring
• Patients with normal left ventricular function
• left ventricular ejection fraction ≥50%
• Patients without structural heart disease

You may not qualify if:

• Pregnant, trying to become pregnant or breast feeding
• History of bronchial asthma
• History of coronary arterial disease

Sponsors & Collaborators

• Keimyung University Dongsan Medical Center: lead
• Chong Kun Dang Pharmaceutical Corp.: collaborator

Study Sites (11)

Keimyung University Dongsan Medical Center

Daegu, 41931, South Korea

RECRUITING

Division of Cardiology, Department of Internal Medicine, Kyungpook National University Hospital

Daegu, 41944, South Korea

RECRUITING

Division of Cardiology, Department of Internal Medicine, Yeungnam University Hospital

Daegu, 42415, South Korea

RECRUITING

Division of Cardiology, Department of Internal Medicine, Daegu Catholic University Medical Center

Daegu, 42472, South Korea

RECRUITING

Chonnam National University Hospital

Gwangju, 61469, South Korea

RECRUITING

Korea University Anam Hospital

Seoul, 02841, South Korea

RECRUITING

Seoul National University Hospital

Seoul, 03080, South Korea

RECRUITING

Severance Cardiovascular Hospital

Seoul, 03722, South Korea

RECRUITING

Seoul Asan Medical Center

Seoul, 05505, South Korea

RECRUITING

Seoul Samsung Medical Center

Seoul, 06351, South Korea

RECRUITING

Seoul St. Mary's Hospital

Seoul, 06591, South Korea

RECRUITING

MeSH Terms

Conditions

Ventricular Premature Complexes

Interventions

Carvedilol; Flecainide

Condition Hierarchy (Ancestors)

Cardiac Complexes, Premature; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 3-Ring; Piperidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Seongwook Han, M.D., Ph.D.

  Keimyung University Dongsan Medical Center

  STUDY CHAIR

Central Study Contacts

Jongmin Hwang, M.D., Ph.D.

CONTACT

+82-53-250-7333; dsmcep@dsmc.or.kr

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2018
• First Posted: July 16, 2018
• Study Start: September 5, 2017
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2020
• Last Updated: July 18, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data will be available within 6 months of study completion.
• Access Criteria: Data access requests will be reviewed by an external independent Review Panel. Requestors will be required to sign a Data Access Agreement.

Locations

KR (11)