Resistant hypertension with subclinical fluid retention in chronic kidney disease Urological and Genital Diseases
Conditions
Interventions
1. Select participants for the research based on inclusion and exclusion criteria.
2. Inform patients about the study and obtain their informed consent to participate.
3. Gather baseline data through
Sponsors
Bhumibol Adulyadej Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 29/10/2024: 1. Age from 18 years old 2. Chronic kidney disease (GFR-EPI 20-60 ml/min/1.73m²) 3. Resistant hypertension with fluid retention detected by bioimpedance _____ Previous inclusion criteria as of 12/04/2024: 1. Age from 18 years old 2. Chronic kidney disease (GFR-EPI 20-60 ml/min/1.73m²) 3. Uncontrolled hypertension with fluid retention detected by bioimpedance _____ Previous inclusion criteria: 1. Age from 18 years old 2. Chronic kidney disease (GFR-EPI 20-60 ml/min/1.73m²) 3. Resistant hypertension
Exclusion criteria
Exclusion criteria: Current exclusion criteria as of 29/10/2024: 1. Patient receiving diuretics or SGLT2i 2. Resistant HT with euvolemic status 3. Life expectancy <12 months (principal investigator’s judgement) 4. Living-donor transplant scheduled within the next 12 months 5. Cardiovascular disease (dilated cardiomyopathy, valvular heart disease) 6. Active infection 7. Current active malignancy 8. Known HIV or active hepatitis B or C 9. Chronic liver disease and/or screening alanine transaminase or aspartate transaminase above 3 times the upper limit of the normal range 10. Pregnancy or breastfeeding 11. Subject has any kind of disorder that compromises their ability to informed consent and/or to comply with study procedures _____ Previous exclusion criteria as of 12/04/2024: 1. Patient receiving diuretics or SGLT2i 2. Uncontrolled HT with euvolemic status 3. Life expectancy <12 months (principal investigator’s judgement) 4. Living-donor transplant scheduled within the next 12 months 5. Cardiovascular disease (dilated cardiomyopathy, valvular heart disease) 6. Active infection 7. Current active malignancy 8. Known HIV or active hepatitis B or C 9. Chronic liver disease and/or screening alanine transaminase or aspartate transaminase above 3 times the upper limit of the normal range 10. Pregnancy or breastfeeding 11. Subject has any kind of disorder that compromises their ability to informed consent and/or to comply with study procedures _____ Previous exclusion criteria: 1. Life expectancy less than 12 months 2. Living-donor transplant scheduled within the next 12 months 3. Cardiovascular disease (dilated cardiomyopathy, valvular heart disease) 4. Active infection 5. Current active malignancy 6. Known HIV or active hepatitis B or C 7. Chronic liver disease and/or screening alanine transaminase or aspartate transaminase above 3 times the upper limit of the normal range 8. Pregnancy or breastfeeding 9. Subject has any kind of disorder that compromises their ability to informed consent and/or to comply with study procedures
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood pressure is measured using sphygmomanometer at baseline and 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 12/04/2024: 1. Urine volume is measured by patient 24-hour urine volume collection at baseline and 6 months 2. LV mass index is measured using Echocardiogram at baseline and 6 months 3. Total body water is measured using bioimpedance at baseline and 6 months 4. Intracellular water is measured using bioimpedance at baseline and 6 months 5. Extracellular water is measured using bioimpedance at baseline and 6 months 6. Extracellular water/total body water is measured using bioimpedance at baseline and 6 months 7. Hospitalization for heart failure reported outcome using an IPD data at 6 months 8. NT-pro BNP level is measured using laboratory blood test at baseline and 6 months 9. eGFR is measured using laboratory blood test at baseline and 6 months 10. Serum sodium is measured using laboratory blood test at baseline and 6 months 11. Urine albumin creatinine ratio is measured using laboratory urine test at baseline and 6 months 12. Urine sodium is measured using laboratory urine test at baseline and 6 months 12. Body weight is measured using weighing at the hospital at baseline and 6 months Previous secondary outcome measures: 1. Urine volume is measured by patient 24-hour urine volume collection at baseline and 6 months 2. LV mass index is measured using Echocardiogram at baseline and 6 months 3. Total body water is measured using bioimpedance at baseline and 6 months 4. Intracellular water is measured using bioimpedance at baseline and 6 months 5. Extracellular water is measured using bioimpedance at baseline and 6 months 6. Extracellular water/total body water is measured using bioimpedance at baseline and 6 months 7. Death from any cause reported outcome using an IPD data at 6 months 8. Fatal or nonfatal myocardial infarction reported outcome using an IPD data at 6 months 9. Hospitalization for heart failure reported outcome using an IPD data at 6 months 10. NT-pro BNP level is measured using laboratory blood test at | — |
Countries
Thailand
Contacts
Public ContactNatchaya Songsilp
Outcome results
None listed