SAFETY AND EFFICACY OF LOSARTAN ON DIALYSIS DEPENDANT CHRONIC KIDNEY DISEASE PATIENTS- AN INDIAN RANDOMISED CONTROLLED TRIAL

Category Primary study
Registry of TrialsClinical Trials Registry - India
Year 2019
INTERVENTION: Intervention1: LOSARTAN 25 MG ONCE DAILY POST DIALYSIS ORALLY FOR 1 WEEK AFTER THAT IF TOLERATED DOSE INCREASED TO 50 MG ONCE DAILY FOR 6 MONTHS: LOSARTAN IS AN ANTI HYPERTENSIVE DRUG THAT USED IN CHRONIC KIDNEY DISEASE NON DIALYSIS DEPENDANT POPULATION TO PRESERVE GFR AND TO DELAY CARDIAC REMODELLING. BUT IN THIS STUDY WE HAVE USED IN DIALYSIS DEPENDANT POPULATION TO SEE ITS EFFECT ON CARDIAC FUNCTION AND RESIDUAL RENAL FUNCTION Control Intervention1: LOSARTAN: LOSARTAN AN ANTI HYPERTENSIVE Control Intervention2: OTHER ANTI HYPERTENSIVES EXCEPT BETA BLOCKER AND MINERALOCORTICOID ANTAGONIST AND ACE INHIBITOR: OTHER ANTI HYPERTENSIVES OTHER THAN BETA BLOCKER AND MINERALOCORTICOID ANTAGONIST AND ACE INHIBITOR ARE USED IN THE CONTROL ARM TO MAINTAIN SIMILAR BP CONTROL CONDITION: Chronic tubulo‐interstitial nephritis PRIMARY OUTCOME: A. The primary outcome will be the percentage of objective improvement of echo‐cardiographic parameters after the study period .Timepoint: 6 MONTHS SECONDARY OUTCOME: a) Mortality during study period. ; b) Adverse effects (hyperkalaemia, hypotension, anaemia, transaminitis, allergic reaction). ; c) Hospital admission due to heart failure ; d) Hypertension requiring more anti‐hypertensives. ; Timepoint: 6 MONTHS INCLUSION CRITERIA: 1. Patient of age within 18‐60 year. 2. CKD stage 5 on haemodialysis. 3. On maintenance haemodialysis 3 per week. 4. A‐V Fistula is used as haemodialysis access. 5. Haemoglobin level > 10gm%. 6. Echo‐cardiographic evidence of Left ventricular hypertrophy. 7. Pre dialysis BP > 140/90 on 2 occassions. 8. No contraindication to any of the medication used in the study.
Epistemonikos ID: 7daa64226dcbd570ed6913742a79733d4ad6f5fd
First added on: Aug 24, 2024