Hypertension in chronic kidney disease patients on hemodialysis

Recruiting

Brief Summary: Cardiovascular events resulting from uncontrolled hypertension is a leading cause of

death in chronic hemodialysis patients. Despite the significant degree of mortality and morbidity,

there is a lot of lacunae in our understanding of an ideal drug to control blood pressure for

prevention of cardiovascular disease in this population. The majority of cardiovascular primary

and secondary prevention clinical trials have excluded patients on hemodialysis. We are doing

this trial to compare two common drugs- Atenolol and Telmisartan in hemodialysis patients with

uncontrolled blood pressure. Efficacy of the drug will be analysed by BP control, reduction of

LVMI (left ventricular mass index) on 2D ECHO. We will also analyse the safety of these 2

drugs in this population. In case any patients develops any side effect, this drug will be

immediately stopped and treatment will be provided to the patient free of cost.

Recruitment & Eligibility

Inclusion Criteria

All the end stage kidney disease patients, above 18 years of age with written informed consent.
On Hemodialysis (CKD stage VD) for more than 3 months. Average of Home BP readings should be more than 135/85mmHg. These readings should be collected in the morning and in the evening over 6 non-dialysis days (covering a period of 2 weeks). OR.
ABPM reading with an average BP of more than 130/80mmHg over 24-h monitoring during a mid-week day free of haemodialysis.

Exclusion Criteria

Patients less than 18 yrs of age.
Patient with pregnancy.
Patients with obstructive airway disease, peripheral vascular disease, uncontrolled blood sugar levels.
Patients with persistent hyperkalemia [K > 6meq/L], or with ECG changes of hyperkalemia 5.
Patients planned to undergo renal transplant within 1 year.
Patients with CV events in the last 3 months 7.
Patients unwilling to give consent.

Primary Outcome Measures

Name	Time	Method
PRIMARY OUTCOME	12 months
Decrease in Echocardiographic Left Ventricular hypertrophy and Left Ventricular Mass Index at the end of 1 year	12 months

Secondary Outcome Measures

Name	Time	Method
SECONDARY OUTCOME	Composite Cardiovascular outcome at the end of one year which include heart failure,coronary revascularization (PTCA/ CABG), myocardial ischemia, angina requiring hospitalization,

Locations (1): King Edward Memorial Hospital
🇮🇳
Mumbai, MAHARASHTRA, India
King Edward Memorial Hospital
🇮🇳Mumbai, MAHARASHTRA, India
Dr Tukaram Jamale
Principal investigator
09167460362
tukaramjamale@yahoo.co.in