Efficacy of the REMIDEP-HTA Program in Hypertension Remission and Pharmacological Deprescription: A Multicenter Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- Proportion of participants with Hypertension Remission
研究概览
简要总结
The REMIDEP-HTA trial is a multicenter randomized controlled study designed to evaluate whether a structured approach combining an intensive lifestyle intervention with a systematic deprescribing algorithm can achieve clinical remission of essential hypertension.
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The intervention integrates a 12-week high-intensity behavioral program focused on whole-food plant-based nutrition, progressive physical activity, sleep hygiene, and stress management, together with a hierarchical, safety-centered medication tapering protocol for antihypertensive therapy.
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The study aims to determine whether remission can be achieved through a standardized and monitored strategy that prioritizes clinical safety during medication withdrawal.
详细描述
The REMIDEP-HTA trial is a multicenter, parallel-group, prospective randomized open-label study with blinded end-point adjudication using a Prospective Randomized Open, Blinded End-point (PROBE) design evaluating the feasibility of achieving clinical remission of essential hypertension.
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Hypertension is defined according to the 2025 American Heart Association/American College of Cardiology (AHA/ACC) Guidelines as blood pressure ≥130/80 millimeters of mercury (mmHg). Blood pressure assessment follows a dual-monitoring strategy combining standardized office measurements and structured home blood pressure monitoring (HBPM) to ensure diagnostic accuracy and safety during follow-up.
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Participants are randomized in a 1:1 allocation ratio to either an experimental intervention or standard care. The study includes a 12-week intervention phase followed by a 12-week follow-up phase to evaluate the sustainability of blood pressure control after medication withdrawal.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Outcome assessors responsible for endpoint adjudication remain blinded to treatment allocation throughout the study. The independent Data Safety Monitoring Board (DSMB) is also blinded and may request unblinding only if necessary for participant safety.
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •<br><br> Men and women aged 40 to 65 years. <br><br> Confirmed diagnosis of chronic essential hypertension established at least 6 months prior to enrollment.
- •<br><br> Stable antihypertensive pharmacological treatment for at least 3 months prior to enrollment, with no changes in medications or dosages.
- •<br><br> Blood pressure at screening ≤ 160/100 millimeters of mercury (mmHg). <br><br> Ability and willingness to comply with the 12-week behavioral intervention, attend scheduled coaching sessions (60-minute group sessions and 10-minute rescue sessions), perform home blood pressure monitoring, and attend clinical visits according to the study schedule.
- •<br><br> Access to an electronic device with internet connectivity sufficient to participate in virtual coaching sessions and to receive and use the program digital materials.
- •<br><br>
排除标准
- •<br><br> Secondary hypertension. <br><br> Use of antihypertensive medications for indications other than treatment of hypertension, or use of non-oral antihypertensive therapy.
- •<br><br> Medical conditions requiring mandatory continuation of antihypertensive therapy for indications other than blood pressure control, precluding medication reduction or withdrawal.
- •<br><br> Physical limitation preventing participation in light-to-moderate intensity physical activity.
- •<br><br> Body mass index (BMI) < 18.5 kg/m² or clinical diagnosis of malnutrition. <br><br> Hospitalization for any cardiovascular cause within 12 months prior to enrollment.
- •<br><br> Pregnancy, breastfeeding, or planned pregnancy during the study period. <br><br> Participation in another interventional clinical study. <br><br> Cognitive impairment, dementia, severe psychiatric disorder, or other condition that prevents adherence to study procedures or reliable communication with the research team.
- •<br><br> Alcohol or illicit substance abuse within the previous 12 months. <br><br> Any medical condition that, in the investigator's opinion, compromises participant safety or the feasibility of medication deprescribing.
研究组 & 干预措施
Intervention Group
REMIDEP-HTA Program: Intensive Lifestyle and Structured Deprescribing
干预措施: Intensive Lifestyle Intervention (Behavioral)
Intervention Group
REMIDEP-HTA Program: Intensive Lifestyle and Structured Deprescribing
干预措施: Pharmacological Deprescribing Algorithm (Other)
Control Group
Standard Hypertension Care (American Heart Association/American College of Cardiology 2025 Guidelines [AHA/ACC])
干预措施: Standard Medical Care (Other)
结局指标
主要结局
Proportion of participants with Hypertension Remission
时间窗: up to 24 weeks
Remission defined by the simultaneous fulfillment of the following criteria: (1) early drug discontinuation, defined as complete suspension of all oral antihypertensive medications within the first 12 weeks of the study; and (2) sustained normotension, defined as blood pressure (BP) \<130/80 millimeters of mercury (mmHg) evaluated through standardized office measurement or validated according to protocol by home blood pressure monitoring (HBPM; home blood pressure monitoring) for at least 12 consecutive weeks following complete withdrawal of the last oral antihypertensive medication.
次要结局
- Change in antihypertensive pharmacological load(Baseline and week 24)
- Proportion of participants with antihypertensive dose modification(Baseline and week 24)
- Change in systolic blood pressure(Baseline, week 12 and week 24)
- Change in diastolic blood pressure(Baseline, week 12 and week 24)
- Change in body mass index (BMI)(Baseline, week 12 and week 24)
- Change in low-density lipoprotein cholesterol concentration (LDL-C)(Baseline, week 12 and week 24)
- Change in glycated hemoglobin (HbA1c) percentage(Baseline, week 12 and week 24)
- Change in the total score of the Simple Lifestyle Indicator Questionnaire (SLIQ)(Baseline and week 24)
- Number of participants with Adverse Events (AE)(up to 24 weeks)
- Number of participants with Serious Adverse Events (SAE)(up to 24 weeks)
- Number of Participants with High Hemodynamic Response Indicator (HHRI)(up to 24 weeks)
研究者
Evelyn Vanina Re
Physician, Cardiologist
Universidad Abierta Interamericana