Comparison of the effect of single-pill combination of valsartan / amlodipine with valsartan alone on left ventricular diastolic dysfunction(LVDD) in patients with hypertension(HTN)
Comparison of the effect of single-drug combination of valsartan / amlodipine with valsartan alone on left ventricular diastolic dysfunction in patients with hypertension
Design
In this double_blind clinical trial, 122 patients with hypertension and left ventricular diastolic dysfunction were randomly divided into two groups using sas software.In Phase 2, 61 patient in one group will receive single pill Valsartan/ Amlodipine 80/5 and in the other group 61 patient will receive Valsartan 80 alone.
Settings and conduct
Outpatients referred to the Clinic of Bou Ali Sina Hospital in Qazvin between 1399-1400, patients who suffered from high blood pressure, randomly devided to two Groups.we tried in first group a single-Pill Valsartan/Amlodipine 80/5 and Valsartan 80 for the second group.Once at the end of the first month,If the blood pressure is not reached to the target,our approach will be increasing the dose of the single pill Valsartan/Amlodipine to160/5 in the first group and using valsartan twice daily in second group.Finally, if the blood pressure is not controlled, that patient excluded from this study and treated with other classes of drugs.Then second echocardiography is performed sixth months later and evaluate left ventricular diastolic function.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 1- HTN ( Grade 1 and more)
2- detectingLVDD on echocardiography
Exclusion criteria:
1-Taking ARB or ACEI drugs in the last three months
2 -left ventricular ejection fraction(LVEF) less than50%
3- Previous allergy or contraindication to the use of the studied drugs
4 Serum Cr above 1.5
5- Lack of blood pressure control
6 -Patient dissatisfaction with continuing the study
7 -Severe valvular disease on echo
Intervention groups
A group receiving single-pill Valsartan /Amlodipine
A group receiving Valsartan alone
Main outcome variables
Left ventricular diastolic dysfunction
General information
Reason for update
Acronym
LVDD
IRCT registration information
IRCT registration number:IRCT20201102049232N1
Registration date:2021-01-01, 1399/10/12
Registration timing:registered_while_recruiting
Last update:2021-01-01, 1399/10/12
Update count:0
Registration date
2021-01-01, 1399/10/12
Registrant information
Name
Ali Pazoki
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 28 3332 6034
Email address
a.pazoki@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-12-21, 1399/10/01
Expected recruitment end date
2021-06-22, 1400/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of single-pill combination of valsartan / amlodipine with valsartan alone on left ventricular diastolic dysfunction(LVDD) in patients with hypertension(HTN)
Public title
effect of valsartan / amlodipine on LVDD
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All patients with newly diagnosed hypertension
Patients with hypertension with evidence of echocardiographic LVDD
Exclusion criteria:
Taking ARB or ACEI drugs in the last three months
Left Ventricular Ejection Fraction less than 50%
Major valvular heart disease
Previous allergy or contraindication to the use of the studied drugs
Serum creatinine above 1.5
Lack of blood pressure control with the studied drugs
Patient dissatisfaction with continuing the study
Age
To 70 years old
Gender
Both
Phase
2-3
Groups that have been masked
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
122
Randomization (investigator's opinion)
Randomized
Randomization description
Simple Randomization
sas Random allocation software
Blinding (investigator's opinion)
Double blinded
Blinding description
The attending physician in the clinic, after examining and examining the entry criteria and after randomization, refers the patient along with the form sheet and completing the initial information for monitoring and delivery of the drug.
After delivery of the drug, the patient is referred to the echo unit for echo and monitoring. From now on, the monitors and people who do the echo at the beginning of the visit and 6 months later and the project analyzer do not know about the patient's medication.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Qazvin University of Medical Sciences
Street address
Bou Ali Street, Bou Ali Sina Hospital
City
qazvin
Province
Qazvin
Postal code
3413786165
Approval date
2020-08-19, 1399/05/29
Ethics committee reference number
IR.QUMS.REC.1399.179
Health conditions studied
1
Description of health condition studied
hypertension
ICD-10 code
I10
ICD-10 code description
Essential (primary) hypertension
2
Description of health condition studied
Left ventricular diastolic dysfunction
ICD-10 code
I50.3
ICD-10 code description
Diastolic (congestive) heart failure
Primary outcomes
1
Description
Left ventricular diastolic dysfunction
Timepoint
At the beginning of the study and 6 months after starting medication for hypertension
Method of measurement
Trans thoracic echocardiography
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: There is a group that receive Abaidi's single pill Valsartan / Amlodipine 80/5 for one month and if the blood pressure is not controlled, the dose will increase to160/5.
Category
Treatment - Drugs
2
Description
Intervention group:There is a group that receives Valsartan80 mg daily of Abaidi alone for a month, and if blood pressure is not controlled, the dose will increase to 160 mg
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Bou Ali Sina Hospital
Full name of responsible person
Zohreh Toudehrousta
Street address
Bou Ali Street -Qazvin
City
Qazvin
Province
Qazvin
Postal code
3413786165
Phone
+98 28 3332 6033
Email
dralipazoki@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Dr. Mohammad Mehdi Emamjumeh
Street address
Qazvin University of Medical Sciences ,Shahid Bahonar Blvd ,Qazvin,
City
Qazvin
Province
Qazvin
Postal code
3419915315
Phone
+98 28 3337 5152
Email
info@qums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Dr. Abidi Pharmaceutical Company
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Industry
Person responsible for general inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Ali Pazoki
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Cardiology
Street address
Bouali Street, Bouali Hospital, Secretariat
City
Qazvin
Province
Qazvin
Postal code
3413786165
Phone
+98 28 3332 6034
Fax
Email
a.pazoki@qums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Ali Pazoki
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Cardiology
Street address
Bouali Street, Bouali Hospital, Secretariat
City
Qazvin
Province
Qazvin
Postal code
3413786165
Phone
+98 28 3332 6034
Fax
Email
a.pazoki@qums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
zohre Toudehrousta
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Cardiology
Street address
Bou Ali Sina Hospital ,Bou Ali Street
City
Qazvin
Province
Qazvin
Postal code
3413786165
Phone
+98 28 3332 6032
Email
zohretuderusta@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is 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
Yes - There is a plan to make this available
Title and more details about the data/document
All data is potentially shareable after unidentified individuals
When the data will become available and for how long
Access period starts 6 months after the results are published
To whom data/document is available
Academic and scientific researchers and Industries
Under which criteria data/document could be used
Permission is granted to use the data for meta-analysis or to design other studies
From where data/document is obtainable
Submit request via email
dralipazoki@gmail.com
a.pazoki@qums.ac.ir
What processes are involved for a request to access data/document
If the applicant submits a request, if 6 months have passed since the publication of the article, it will be answered in less than 1 week.