NCT05976477尚未招募不适用
Reduction Of Dietary Salt Intake To Control Systolic Blood Pressure In Hypertensive Older Patients: The Repress Randomized Controlled Trial
Mario Negri Institute for Pharmacological Research0 个研究点目标入组 266 人开始时间: 2023年10月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 266
- 主要终点
- Change in systolic BP
研究概览
简要总结
REPRESS is an open label, pragmatic, multicenter, randomized controlled phase III trial with blinded endpoint with 1:1 (intervention to control arm) allocation ratio.
The REPRESS trial is aimed to determine the efficacy of an educational intervention aimed at reducing dietary salt intake in elderly people (60+) with moderate hypertension and exposed to polypharmacy (3+ drugs) in improving systolic BP control compared to an attention arm.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Community-dwelling patients aged ≥60 years;
- •Prescribed ≥3 drugs;
- •A) Systolic blood pressure ≥130 and ≤160 mmHg for patients prescribed stable antihypertensive therapy (at least 1 drug (ATC code: C02*, C03*, C07*, C08*, C09*)); B) Systolic blood pressure ≥140 and ≤160 mmHg for those patients not prescribed any antihypertensive drug;
- •Capable of feeding independently;
- •Own a smartphone;
- •Frequently consuming home-cooked meals (≥4 days during a week and ≥3 during the weekend per month);
- •Giving signed informed consent.
排除标准
- •Living in a nursing home or having applied for nursing home admission;
- •Being prescribed (adding, switching or changing dosage) an antihypertensive drug in the three months before enrollment;
- •Undergoing renal replacement therapy with dialysis or having renal impairment with estimated glomerular filtration rate (eGFR) <25 mL/min/1.73 m2 (assessed by CKD-EPI formula) [30] within previous six months or at the screening assessment;
- •Following a low-sodium dietary regimen;
- •Being unable or refusing to sign informed consent.
结局指标
主要结局
Change in systolic BP
时间窗: 6 months
The primary outcome will be the change in systolic BP defined as the difference from baseline to 12 weeks follow-up in the two study groups.
次要结局
- Change in 24-hour urinary sodium excretion(6 and 12 months)
- Change in adherence to the mediterranean diet(6 and 12 months)
- Incidence of cardio- and cerebro-vascular events(12 months)
研究者
Carlotta Franchi
PRINCIPAL INVESTIGATOR
Mario Negri Institute for Pharmacological Research
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