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IRCT20230926059524N1 IRCT 2023-12-28 Iran University of Medical Sciences The Effect of Sacubitril-Valsartan on RV function The Effectiveness of Sacubitril-Valsartan with ACEI/ARBs on Right Ventricular Function in Patients with Right Sided Heart Failure; A Randomized Clinical Controlled Trial 2024-01-21 anticipated 84 Complete https://irct.ir/trial/73288 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this clinical trial study, 84 patients with Right Sided Heart Failure will be included in the study. For random allocation of individuals in the study groups (intervention group and comparison group), the method of random allocation with block method (Block Randomization) will be used. In this method, blocks with a size of six (including three people in the intervention group and three people in the comparison group) with a ratio of 1:1 will be used (14 blocks of 6). Random Allocation software will be used to generate random sequences. The random allocation concealment method is used in such a way that random sequences are created. In this method, they are identified on the cards and these cards are placed inside the sealed envelopes in order. In order to maintain the created sequence, the numbering will be recorded on the outer surface of the envelopes. Finally, the numbered envelopes will be placed in a folder. Then, according to the order of entry of the eligible participants, the envelopes will be opened and the assigned group of the participant will be determined. 3 Condition 1: Ischemic cardiomyopathy. Condition 2: Dilated cardiomyopathy. Intervention 1: Intervention group: Sacubitril valsartan (under the brand name: Artrestan, Arena Hayat co) with the starting dose of 50mg twice daily will be prescribed to patients with any degree of RV dysfunction on the condition of systolic blood pressure at more than 100mmHg, creatinine less than 2.5. on the follow up visits,the dose will be escalated to 100mg twice daily if the patient could tolerate that.at the end of the trimestre, the patients will have another echocardiography done again. Intervention 2: Control group: Losartan(under the brand name: losartan, Zagros co.) with the starting dose of 25mg daily will be prescribed to patients with any degree of RV dysfunction on the condition of systolic blood pressure at more than 100mmHg, creatinine less than 2.5. on the follow up visits,the dose will be escalated to 50mg daily if the patient could tolerate that.at the end of the trimestre, the patients will have another echocardiography done again. Intervention 3: Control group: Captopril (under the brand name: Tedapharm, Tehran Darou co.) with the starting dose of 6.25mg TDS will be prescribed to patients with any degree of RV dysfunction on the condition of systolic blood pressure at more than 100mmHg, creatinine less than 2.5. on the follow up visits,the dose will be escalated to 50mg TDS if the patient could tolerate that.at the end of the trimestre, the patients will have another echocardiography done again. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is there is no more information
public Zeinali, Elahe
Rasool akram hospital,Maziar Mansouri st, Sattarkhan ave.
Tehran Iran (Islamic Republic of) 1445613131 +98 21 6435 2466 Elahezeinali93@gmail.com Iran University of Medical Sciences scientific Elahe Zeinali
2nd floor,No.22, Fath street, 3rd Fath alley, Adl Blvd, Tehran,Iran
Tehran Iran (Islamic Republic of) 1445613131 +98 34 3422 6260 Elahezeinali93@gmail.com Iran University of Medical Sciences Iran (Islamic Republic of) patients who aged over 18 years old patients with any degree of right ventricular failure written and informed consent 18 years no limit Both glomerular filteration rate less than 30 mg/dl systolic blood pressure less than 100 mmHg history of angioedema right heart failure due to acute pulmonary emboli creatinine more than 2.5mg/dl renal artery stenosis hisory of intolerance to the mentioned drugs Death Lack of consent to prticipate in the study I25.5 I42.0 Ischemic cardiomyopathy Dilated cardiomyopathy Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention group: Sacubitril valsartan (under the brand name: Artrestan, Arena Hayat co) with the starting dose of 50mg twice daily will be prescribed to patients with any degree of RV dysfunction on the condition of systolic blood pressure at more than 100mmHg, creatinine less than 2.5. on the follow up visits,the dose will be escalated to 100mg twice daily if the patient could tolerate that.at the end of the trimestre, the patients will have another echocardiography done again Control group: Losartan(under the brand name: losartan, Zagros co.) with the starting dose of 25mg daily will be prescribed to patients with any degree of RV dysfunction on the condition of systolic blood pressure at more than 100mmHg, creatinine less than 2.5. on the follow up visits,the dose will be escalated to 50mg daily if the patient could tolerate that.at the end of the trimestre, the patients will have another echocardiography done again Control group: Captopril (under the brand name: Tedapharm, Tehran Darou co.) with the starting dose of 6.25mg TDS will be prescribed to patients with any degree of RV dysfunction on the condition of systolic blood pressure at more than 100mmHg, creatinine less than 2.5. on the follow up visits,the dose will be escalated to 50mg TDS if the patient could tolerate that.at the end of the trimestre, the patients will have another echocardiography done again Degree of RV dysfunction. Timepoint: At the beginning of the trial, 3 months after using the drug. Method of measurement: Echocardiography. Iran University of Medical Sciences Approved 2023-03-05 Ethics committee of Iran university of medical science Rasool akram hospital, Maziar Mansouri st, SattarKhan Ave. Tehran Tehran Iran (Islamic Republic of)