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IRCT20201102049232N1 IRCT 2021-01-01 Qazvin University of Medical Sciences effect of valsartan / amlodipine on LVDD LVDD 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) 2020-12-21 anticipated 122 Complete https://irct.ir/trial/52009 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple Randomization sas Random allocation software, 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. 2-3 Condition 1: hypertension. Condition 2: Left ventricular diastolic dysfunction. Intervention 1: 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. Intervention 2: 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. Yes - There is a plan to make this available What will be shared: All data is potentially shareable after unidentified individuals When: Access period starts 6 months after the results are published To whom: Academic and scientific researchers and Industries Conditions: Permission is granted to use the data for meta-analysis or to design other studies Where to obtain: Submit request via email dralipazoki@gmail.com a.pazoki@qums.ac.ir How to obtain: 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. Comments:
public Ali Pazoki
Bouali Street, Bouali Hospital, Secretariat
Qazvin Iran (Islamic Republic of) 3413786165 +98 28 3332 6034 a.pazoki@qums.ac.ir Qazvin University of Medical Sciences scientific Ali Pazoki
Bouali Street, Bouali Hospital, Secretariat
Qazvin Iran (Islamic Republic of) 3413786165 +98 28 3332 6034 a.pazoki@qums.ac.ir Qazvin University of Medical Sciences Iran (Islamic Republic of) All patients with newly diagnosed hypertension Patients with hypertension with evidence of echocardiographic LVDD no limit 70 years Both 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 I10 I50.3 Essential (primary) hypertension Diastolic (congestive) heart failure Treatment - Drugs Treatment - Drugs 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. 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 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. Dr. Abidi Pharmaceutical Company Approved 2020-08-19 Ethics Committee of Qazvin University of Medical Sciences Bou Ali Street, Bou Ali Sina Hospital qazvin Qazvin Iran (Islamic Republic of)