]>
IRCT20240701062299N2 IRCT 2025-01-28 Shiraz University of Medical Sciences Bisoprolol vs, standard therapy; managing Hypertension in adults The effect of bisoprolol monotherapy for the management of hypertension of otherwise healthy adults younger than 60 years compared to the standard therapy with valsartanamlodipine 2022-08-01 anticipated 70 Complete https://irct.ir/trial/81026 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Factorial, Purpose: Treatment, Randomization description: After checking eligibility, patients are randomly selected using block randomization method with a block size of 4. To achieve blinding, patients are randomly divided into groups A and B. Group A is assigned to bisoprolol and group B is assigned to valsartan + amlodipine, Blinding description: To achieve blinding, patients are randomly divided into groups A and B. Group A will be allocated to bisoprolol and Group B to valsartan + amlodipine, but this allocation will not be evident to the project implementers and study analysts until the end of the study. 3 Hypertension. Intervention 1: Intervention group: bisoprolol monotherapy. Intervention 2: Control group: valsartan-amlodipine. Yes - There is a plan to make this available What will be shared: Only a part of the data, such as information about the main outcome or the like, can be shared. When: Start of the Access Period 6 months after the results are printed To whom: It will be available for researchers working in academic and scientific institutions Conditions: - Where to obtain: Info@kojuriclinic.com How to obtain: Start of the Access Period 6 months after the results are printed Comments:
public Javad Kojuri
Cardiology department, Alzahra Heart Hospital, Sibooye Blvd
Shiraz Iran (Islamic Republic of) - +98 71 3735 5093 kojurij@yahoo.com Shiraz University of Medical Sciences scientific Javad Kojuri
Cardiology department, Alzahra Heart Hospital, Sibooye Blvd
Shiraz Iran (Islamic Republic of) - +98 71 3735 5093 kojurij@yahoo.com Shiraz University of Medical Sciences Iran (Islamic Republic of) age between 18 and 60 years stage one or two hypertension recently diagnosed 16 years 60 years Both any contraindications to beta-blockers, CCBs, or ARBs (e.g. symptomatic bradycardia, asthma, advanced renal failure, serum potassium > 5.5 mEq/L, severe edema of the lower extremities, etc.), associated complications that suggest the use of a specific agent (e.g., diabetes, heart failure, CKD, etc.), They will have extremely high blood pressure (SBP>= 180 and/or DBP>= 110), and the use of other medications that interact with beta-blockers, CCBs, or ARBs. Treatment - Drugs Treatment - Drugs Intervention group: bisoprolol monotherapy Control group: valsartan-amlodipine Blood pressure control. Timepoint: Q: From the start of the study, patients will be followed up on a weekly basis with phone calls (by experienced medical staff with sufficient knowledge about hypertension and its complications) to assess their blood pressure levels (and assess the need to adjust the dose, or change in medications to prevent any disease) and after 2 months, secondary ABPM will be performed for all participants to help us in the analysis. and help analyze the data accurately and discuss the results. Method of measurement: Q: From the start of the study, patients will be followed up on a weekly basis with phone calls (by experienced medical staff with sufficient knowledge about hypertension and its complications) to assess their blood pressure levels (and assess the need to adjust the dose, or change in medications to prevent any disease) and after 2 months, secondary ABPM will be performed for all participants to help us in the analysis. and help analyze the data accurately and discuss the results. Shiraz University of Medical Sciences Approved 2023-07-23 Ethics Committee of Shiraz University of Medical Sciences Above Qasr-e-Dasht Square, East Mirza Shirazi Street, Alley 7 Side of Haft Momayez Eight, the second alley on the right shiraz Fars Iran (Islamic Republic of)