Comparison of the efficacy of Ranolazine with placebo for reducing ventricular premature beats (VPBs) in patients with high burden of VPBs in holter monitoring
Comparison of the efficacy of ranolazine with placebo for reducing ventricular premature beats (VPBs) in patients with high burden of VPBs
Design
Randomized placebo-controlled trial, double blinded, two arm parallel 1:1 groups; with 96 participants;
Random sequence wil be generated by R software, blockrand package
Settings and conduct
Using block randomization, patients will be allocated to two arms (1:1 ratio), receiving ranolazine or placebo. After 30 days, second visit will be done and patients will be assessed with Holter monitoring. Blinding will be achieved through using ranolazine and placebo pills that are identical in appearance, and are manufactured by the same pharmaceutical company. Participants, the principal investigator, the echocardiography specialist, the recruiting physician, the outcome assessor, and nurse investigators who collect data and complete forms will all be blinded in the trial.
Participants/Inclusion and exclusion criteria
Inclusion: Age of 18 years or older; with a premature ventricular beat burden between 10-30%.
Exclusion: Ventricular tachycardia or fibrillation; atrial fibrillation; long QT interval; history of renal or hepatic disease; concurrent use of medications known to have drug interactions with ranolazine; prior recent use of ranolazine; history of adverse effects with ranolazine; pregnancy or breast feeding; not having informed consent
Intervention groups
Intervention: ranolazine 1000 mg Bid for 30 days; manufactured by Koushan Pharmed
Control: placebo for 30 days; manufactured by Koushan Pharmed
Main outcome variables
Difference in ventricular premature beat burden before and after treatment
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220515054863N2
Registration date:2022-11-01, 1401/08/10
Registration timing:prospective
Last update:2022-11-01, 1401/08/10
Update count:0
Registration date
2022-11-01, 1401/08/10
Registrant information
Name
Masih Tajdini
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8802 9600
Email address
mtajdini@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-12-01, 1401/09/10
Expected recruitment end date
2023-09-01, 1402/06/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the efficacy of Ranolazine with placebo for reducing ventricular premature beats (VPBs) in patients with high burden of VPBs in holter monitoring
Public title
Efficacy of Ranolazine in treating ventricular premature beats
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Minimum age of 18
PVC burden between 10 to 30 percent among whole beats
Exclusion criteria:
Patients with Atrial Fibrillation (AF)
Patients diagnosed with ischemic ventricular tachycardia (VT)
Patients with a history of serious ventricular tachyarrhythmias in the past 4 weeks (e.g., sustained ventricular tachycardia and ventricular fibrillation)
Patients who have a QT interval higher than 550 milliseconds or consume medications that prolong the QT interval
Patients with a heart transplant
Patients undergoing dialysis
Patients with a creatinine clearance below 30 ml/min or a blood creatinine over 2.5 mg/dl
Patients with moderate to severe hepatic dysfunction
Patients receiving metformin with a dose extending 1000 mg Bid
Patients receiving simvastatin with a daily dose extending 20 mg
Patients receiving Dabigatran
Patients receiving a CYP3A4 inhibitor (Ketoconazole, Clarithromycin, Ritonavir, Diltiazem, Fluconazole, Erythromycin, Verapamil or grapefruit juice)
Patients with a history of Ranolazine consumption in the past two months
Patients who have previously discontinued Ranolazine due to side effects
Pregnant or breastfeeding patients, or patients planning for pregnancy during the study period
Patients without informed consent
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
96
Randomization (investigator's opinion)
Randomized
Randomization description
Eligible participants will be randomized to two 1:1 parallel arms receiving ranolazine or placebo. The random sequence will be generated by R software "blockrand" package, with the method of block randomization in block sizes of 2, 4, and 6.
Trial medications (ranolazine and placebo) will be identical in appearance, and stored in sequentially numbered sealed opaque unlabeled boxing. An unblinded investigator will put a number on the medications’ boxing prior to the start of recruitment, according to the random sequence. Each patient who is enrolled will receive the appropriate sequentially numbered and blinded box of medications, which contains pills prescribed for the duration of the study.
Patients will receive medications after enrollment, completion of baseline forms, and providing informed consent. A randomization log will be kept at the recruitment site to ensure sequential allocation of treatments. Allocation concealment is ensured by using variable block sizes. Moreover, the ranolazine and placebo pills and their boxing are completely identical; therefore, guessing the next treatment allocation would not be possible.
Blinding (investigator's opinion)
Double blinded
Blinding description
Blinding will be achieved through using ranolazine and placebo pills that are identical in appearance, and are manufactured by the same pharmaceutical company (Koushan Pharmed).
Participants, the principal investigator, the echocardiography specialist, the recruiting physician, the outcome assessor, and nurse investigators who collect data and complete forms will all be blinded in the trial. Each participant receives a unique code and all of the forms will be filled out based on the code. During the statistical analysis, it will be determined whether each code is related to Ranolazine or placebo.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tehran Heart Center-Tehran University of Medical Sciences