None listed
Conditions
Brief summary
Since there is a constant volume variation during hemodialysis session, there is a strong possibility for the activation of RAAS system. The activation of RAAS system leads to narrowing of the lumen of blood vessels thus leading to rise in blood pressure even if the patient is euvolumic. Considering the importance of RAAS system in euvolumic hypertensive patients, the role of drugs blocking RAAS system needs further investigation. Hence the current randomized control trial is based on role of ARBs (losartan) in managing blood pressure among euvolumic hemodialysis patients
Interventions
1. The intervention group, on top of standard antihypertensive medication (calcium channel blocker, alpha and beta blocker) will receive ARB (losartan) among post dialysis euvolumic hypertensive patients.
2. The ARB used for current RCT is “Losartan”. The selection of Losartan was based on availability, cost effectiveness and expert opinion of a Nephrologist and a cardiologist. Starting dose of 50 mg/day of losartan oral tablet will be given to recruited patients. Persistent high post dialysis
1. The intervention group, on top of standard antihypertensive medication (calcium channel blocker, alpha and beta blocker) will receive ARB (losartan) among post dialysis euvolumic hypertensive patients. 2. The ARB used for current RCT is “Losartan”. The selection of Losartan was based on availability, cost effectiveness and expert opinion of a Nephrologist and a cardiologist. Starting dose of 50 mg/day of losartan oral tablet will be given to recruited patients. Persistent high post dialysis blood pressure of >160mmHg or unable to attain targeted blood pressure of 140mmHg for a period of four months, upon consultation with a cardiologist and nephrologists the dose of losartan will be titrated up to 100mg/day. Moreover, based on patient response to initial 50mg/day dose, cardiologist may titrate the dose up to 100mg/day before 4 months so as to avoid any detrimental effect on subject health.(NKF KDOQI guideline 2004, to be followed for dose titration) A person in family of the patient will be asked to monitor the adherence of given medication. contact number and frequent meeting with the designated person will be arranged with the investigator to closely monitor the adherence of medication. 3. The maximum study duration is 8 months. Since there are two intervention dose of losartan, a 4 month period of each dose (50mg/day, 100mg/day) will be allowed to note patient response. Failure to achieve and maintain targeted systolic blood pressure of <140mmHg for three weeks with 50mg/day dose during the first 4 months, the subjects will be titrated to 100mg/day for next 4 months or if study end point achieved (maintaining<140mmHg for three weeks) 4. Dose of losartan to be administered at morning after breakfast except on dialysis session days, to avoid any incidence of hypotension.
Sponsors
Universiti Sains Malaysia
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject)
Eligibility
Sex/Gender
All
Age
30 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
Euvolumic patients with blood pressure more than 140/90 mmHg post dialysis will be included for the study. On basis of expert opinion from nephrologists, patient 30-80 years were included for current study. Finally, patients undergoing dialysis duration of at least 12 months, 2 to 3 HD sessions weekly and Patients willing to participate were included for current study.
Exclusion criteria
Patients with amputations, neoplasm and cystic kidneys, unwilling to participated in the study. Patients already on ARBs and Patients with symptomatic hypotension or SBP less than 110 mm Hg were excluded from the study
Outcome results
None listed