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Investigating the effect of rose hip alcoholic extract on the ventricular arrhythmia in heart failure patients with Implantable Cardioverter Defibrillator

Protocol summary

Study aim
Investigating the effect of rose hip alcoholic extract on the ventricular arrhythmia in heart failure patients with Implantable Cardioverter Defibrillator
Design
Phase 3 randomized double-blinded placebo parallel clinical trial on 72 patients. Randomization using Randomaization.com
Settings and conduct
This study will be performed on heart failure patients with an Implantable Cardioverter Defibrillator in the heart ward of Imam Reza Hospital in Mashhad. Patients are randomly assigned to rose hip and placebo groups. Randomization will be done using a block method with a block size of 4. The blocked randomization method is used with the volume of each block of four. Sealed envelopes will be used to conceal allocation. A person not involved in sampling and data collection will prepare envelopes and randomize allocation. Due to the use of a placebo similar to the intervention treatment, the investigator and the participants will not be informed of the assigned treatment, and the analyst will also be unaware of the assigned treatment for the two groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age older than 18 years old; Heart failure diagnosis; ICD implantation > 3 months before eligibility test; Signed written informed consent to participate in the study. Not-Inclusion criteria: New York Heart Association Class IV heart failure; Renal dysfunction with eGFR < 30; Hepatic dysfunction; Body mass index < 18.5 kg/m2; Pregnant or suspected pregnancy; ICDs unable to record cardiac arrhythmias.
Intervention groups
Intervention group: Taking 250 mg Rose hip alcoholic extract tablets four times a day. Placebo group: Taking placebo tablets four times a day.
Main outcome variables
Frequency of the ventricular arrhythmias (PVC, NSVT, VT, VF)

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220516054874N17
Registration date: 2024-07-05, 1403/04/15
Registration timing: registered_while_recruiting

Last update: 2024-07-05, 1403/04/15
Update count: 0
Registration date
2024-07-05, 1403/04/15
Registrant information
Name
Vafa Baradaran Rahimi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3800 2301
Email address
baradaranrv@mums.ac.ir
Recruitment status
recruiting
Funding source
Expected recruitment start date
2024-07-05, 1403/04/15
Expected recruitment end date
2026-07-06, 1405/04/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of rose hip alcoholic extract on the ventricular arrhythmia in heart failure patients with Implantable Cardioverter Defibrillator
Public title
The effect of rose hip alcoholic extract on the ventricular arrhythmia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age older than 18 years old Heart failure diagnosis ICD implantation > 6 months before eligibility test Signed written informed consent to participate in the study
Exclusion criteria:
New York Heart Association Class IV heart failure Renal dysfunction with eGFR < 20 Hepatic dysfunction Body mass index < 18.5 kg/m2 Pregnant or suspected pregnancy Patients with the following events within 3months before the eligibility test: alteration of antiarrhythmic drug, catheter ablation for ventricular arrhythmia, coronary revascularization, open-heart surgery, development of coronary artery disease, stroke or transient ischemic stroke, seizure, infection requiring hospitalization, heart failure requiring hospitalization Other comorbidities including various infections, major surgery, type 1 diabetes, pituitary or adrenal insufficiency, cancer ICDs unable to record cardiac arrhythmias
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
Sample size
Target sample size: 72
Randomization (investigator's opinion)
Randomized
Randomization description
The blocked randomization method is used. The volume of each block will be four. Then the list of possible blocks is written and numbers assigned to them, for example (AABB(1)- BBAA(2)- BABA(3)- BAAB(4)), which will be 18 blocks according to the sample size of 72. Then random numbers between 1 and 18are selected according to the randomization site Randomaization.com and finally, the treatment allocation list is determined based on the random numbers. Sealed envelopes will be used to conceal allocation. A person not involved in sampling and data collection will prepare envelopes and randomize allocation.
Blinding (investigator's opinion)
Double blinded
Blinding description
Blinding will performed using sealed envelopes. Due to the use of a placebo similar to the intervention treatment, the investigator and the participants will not be informed of the assigned treatment, and the analyst will also be unaware of the assigned treatment for the two groups. Finally, after analyzing the data, the researcher who prepared the packages will reveal the codes A and B.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committee of Imam Reza Hospital Educational, Research and Treatment Center, Mashhad
Street address
Imam Reza Hospital educational complex building, Imam Reza Hospital, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
Approval date
2024-05-13, 1403/02/24
Ethics committee reference number
IR.MUMS.IRH.REC.1403.041

Health conditions studied

1

Description of health condition studied
Ventricular arrhythmia
ICD-10 code
I47
ICD-10 code description
Paroxysmal tachycardia

Primary outcomes

1

Description
Frequency of the ventricular arrhythmias (PVC, NSVT, VT, VF)
Timepoint
The beginning of the study and one months later
Method of measurement
ICD (implantable cardioverter-defibrillator) record

Secondary outcomes

1

Description
Hospitalization
Timepoint
The beginning of the study and one month later
Method of measurement
Checklist

Intervention groups

1

Description
Intervention group: Taking rose hip alcoholic extract 250 mg tablets four times a day for one month
Category
Treatment - Drugs

2

Description
Control group: Taking placebo tablets, which look exactly like 250 mg rose hip alcoholic extract tablet. Placebo will be prepared in the Pharmaceutics Laboratory of Mashhad School of Pharmacy and will be performed four times a day for one month.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Department of Cardiology, Imam Reza Hospital
Full name of responsible person
Dr. Zahra Zandi
Street address
Imam Reza hospital, Ebnsina Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
Phone
+98 51 3854 3031
Email
zandiz@mums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Mohsen Tafaghodi
Street address
Qurashi Building, Next to Hoveyzeh Cinema, University Street, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 1538
Email
Ramresearch@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Zahra Zandi
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Cardiology
Street address
Imam Reza hospital, Ahmadabad Blvd, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
0095 5138012739
Email
zandiz@mums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Zahra Zandi
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Cardiology
Street address
Imam Reza hospital, Ahmadabad Blvd, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
0095 5138012739
Email
zandiz@mums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Vafa Baradaran Rahimi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Ghaeem hospital, Ahmadabad Blvd, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
0095 5138012739
Email
baradaranrv@mums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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