2022-501494-39-00招募中3 期
THINK - intensification of blood pressure lowering Therapeutics based on diuretics versus usual management for uncontrolled Hypertension IN patients with moderate to severe chronic Kidney disease: an open label, cluster randomized controlled, phase 3 trial
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 720
- 试验地点
- 34
- 主要终点
- 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
研究概览
简要总结
To assess the efficacy of an algorithm based on diuretic agents in patients with moderate to severe chronic kidney disease and uncontrolled hypertension in reducing the incidence of end-stage kidney disease, chronic kidney disease progression, cardiovascular events and mortality
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Male or female >=18 years with a clinical frailty score ≤5 for patient aged over 80
- •Participant covered by or entitled to social security
- •Written informed consent obtained from the participant
- •Advanced or moderate chronic kidney disease (eGFR 15.0 to 44.9 ml/mn/1.73m² using CKD-Epi formula)
- •Arterial hypertension treated with at least one blood pressure lowering drug therapy among blockers of the renin-angiotensin system (ACEi or ARB), at the maximal posology tolerated by the patients, stable since at least one month. Other blood pressure lowering drug therapies are tolerated in combination with or in the event of intolerance to ACE inhibitors or ARBs.
- •Uncontrolled office BP (>140 and/or 90 mmHg) confirmed by home blood pressure monitoring (> 135 and/or 85 mmHg) or Day-time Ambulatory Blood Pressure Monitoring.
排除标准
- •Patient following any measures of legal presentation
- •Symptomatic orthostatic hypotension
- •Hyponatremia (<130 mmol/L)
- •Dyskalemia (<3,5 mmol/L or >5,5 mmol/L)
- •Major adverse cardiovascular event during the last three months: myocardial infarction, heart failure hospitalization, stroke
- •Current medical history of cancer requiring chemotherapy
- •Solid organ transplantation
- •woman of childbearing without a highly effective contraceptive measure (combined or progestogen-only hormonal contraception associated with inhibition of ovulation, intrauterine device or intrauterine hormone-releasing system)
- •Two or more diuretic agents (loop diuretic, thiazides and thiazide-like diuretics)
- •Mineralocorticoid receptor antagonists
- •Autosomal dominant polycystic kidney disease treated with Tolvaptan
- •Contraindication to diuretics involved in the algorithm
- •Severe heart failure (NYHA III_IV)
- •Cirrhosis Child B-C
- •Pregnant or breastfeeding woman
- •Clinical signs of hypovolemia
结局指标
主要结局
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
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
次要结局
- 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
研究者
Coordinating Investigator
Scientific
Centre Hospitalier Regional Universitaire De Tours
研究点 (34)
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