Uncontrolled Hypertension IN patients with moderate to severe chronic Kidney disease
Conditions
Brief summary
Time to event outcome, considering the following composite endpoint: end stage kidney disease (need for kidney replacement therapy or renal transplantation), eGFR decline ≥40% (CKD-EPI formula), cardiovascular events (myocardial infarction, heart failure hospitalization, stroke), all cause mortality
Detailed description
Time to end-stage kidney disease, Time to eGFR decrease ≥40%, Time to the first cardiovascular event (myocardial infarction, heart failure hospitalization, stroke), All cause mortality, Change from baseline systolic and diastolic blood pressure at months 3 and 6 then every 6 months (home blood pressure monitoring and office blood pressure measurement), Proportion of patients with controlled blood pressure at 2 years (PA< 135 and/or 85mmHg with home blood pressure monitoring), Change from baseline in glomerular filtration rate estimated by CKD-EPI formula at months 3 and 6 then every 6 months, Change from baseline in proteinuria (g/d) or proteinuria /creatininuria (g/g) at months 3 and 6 then every 6 months, Proportion of patients who used at least one diuretic, Change from baseline in quality of life assessed by PROMIS-29 survey each year, Safety: volume depletion, dyskalemia, hyponatremia, acute kidney injury, gout, orthostatic hypotension symptomatic/asymptomatic or complicated by falls
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to event outcome, considering the following composite endpoint: end stage kidney disease (need for kidney replacement therapy or renal transplantation), eGFR decline ≥40% (CKD-EPI formula), cardiovascular events (myocardial infarction, heart failure hospitalization, stroke), all cause mortality | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to end-stage kidney disease, Time to eGFR decrease ≥40%, Time to the first cardiovascular event (myocardial infarction, heart failure hospitalization, stroke), All cause mortality, Change from baseline systolic and diastolic blood pressure at months 3 and 6 then every 6 months (home blood pressure monitoring and office blood pressure measurement), Proportion of patients with controlled blood pressure at 2 years (PA< 135 and/or 85mmHg with home blood pressure monitoring), Change from baseline in glomerular filtration rate estimated by CKD-EPI formula at months 3 and 6 then every 6 months, Change from baseline in proteinuria (g/d) or proteinuria /creatininuria (g/g) at months 3 and 6 then every 6 months, Proportion of patients who used at least one diuretic, Change from baseline in quality of life assessed by PROMIS-29 survey each year, Safety: volume depletion, dyskalemia, hyponatremia, acute kidney injury, gout, orthostatic hypotension symptomatic/asymptomatic or complicated by f | — |
Countries
France