Health Condition 1: N186- End stage renal disease
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
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
Exclusion criteria: 1. Patients less than 18 yrs of age. 2. Patient with pregnancy. 3. Patients with obstructive airway disease, peripheral vascular disease, uncontrolled blood sugar levels. 4. Patients with persistent hyperkalemia [K > 6meq/L], or with ECG changes of hyperkalemia 5. Patients planned to undergo renal transplant within 1 year. 6. Patients with CV events in the last 3 months 7. Patients unwilling to give consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PRIMARY OUTCOME Decrease in Echocardiographic Left Ventricular hypertrophy and Left Ventricular Mass Index at the end of 1 year Timepoint: 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| SECONDARY OUTCOME Composite Cardiovascular outcome at the end of one year which include heart failure,coronary revascularization (PTCA/ CABG), myocardial ischemia, angina requiring hospitalization, hemorrhagic and non hemorrhagic intracranial infarcts and intracranial bleeding. Improvement in ABPM parameter- Average systolic and diastolic BP, Night to day Systolic BP ratio at the end of 1 year. Adverse effects seen the usage of drugs- hyperkalemia, bradycardia, hypotension (less than 100mmHG systolic BP), arrythmia during 1 year. Secondary arterio venous fistula failure due to hypotension during 1 year Number of anti hypertensive medications required for control of blood pressure at 1 year Number of hospitalization due to cardiac failure during 1 year Hospitalization due to uncontrolled blood pressure within 1 year All cause mortality in 1 year. Timepoint: 1 year | — |
Countries
India
Contacts
Seth GSMC and KEM hospital Mumbai