REMIDEP-HTA Program for Hypertension Remission and Medication Deprescription

Официальное название

Efficacy of the REMIDEP-HTA Program in Hypertension Remission and Pharmacological Deprescription: A Multicenter Randomized Clinical Trial

Обзор

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. \<br\>\<br\> 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. \<br\>\<br\> The study aims to determine whether remission can be achieved through a standardized and monitored strategy that prioritizes clinical safety during medication withdrawal.

Подробное описание

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.

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The experimental intervention combines an intensive lifestyle program with a structured, safety-centered deprescribing algorithm. The lifestyle component integrates whole-food plant-based nutrition adapted from the Dietary Approaches to Stop Hypertension (DASH) model, progressive physical activity, sleep hygiene strategies, and stress management, supported by standardized weekly virtual group sessions.

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Medication tapering is guided by a hierarchical deprescribing algorithm activated once predefined blood pressure stability criteria are achieved. Dose adjustments follow a structured priority framework with drug-class-specific strategies and a predefined traffic-light clinical conduct model based on home blood pressure averages. Safety interruption thresholds and rescue strategies are incorporated to ensure clinical stability. Psychological support is available on demand to address potential stress related to medication withdrawal.

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Safety is monitored throughout the study through systematic documentation of adverse events and predefined indicators of clinically significant hypotension, with oversight by an independent Data Safety Monitoring Board (DSMB).

Вмешательства

• Поведенческое Intensive Lifestyle Intervention
  A structured 12-week program implemented across four pillars: 100% whole food plant-based nutrition, dosed and progressive physical exercise (aerobic and strength), sleep hygiene, and stress management through guided breathing. It includes weekly 60-minute synchronous virtual group coaching sessions.
• Другое Pharmacological Deprescribing Algorithm
  A structured clinical decision framework for the supervised reduction or discontinuation of oral antihypertensive medications. The algorithm is activated upon reaching a confirmed office blood pressure trigger value of ≤125/75 mmHg following exposure to the lifestyle intervention. Medication tapering follows a hierarchical strategy organized by pharmacological class, incorporating standardized dose-reduction protocols tailored to drug pharmacodynamics, safety profiles, evidence of cardioprotect
• Другое Standard Medical Care
  Participants in this arm receive standard medical management for hypertension in accordance with the 2025 American Heart Association/American College of Cardiology (AHA/ACC) Guidelines. These guidelines explicitly include lifestyle modification recommendations - such as dietary changes, physical activity, weight management, and other behavioral measures - which may be addressed by the treating physician as part of routine clinical care. All pharmacological adjustments, including dose reduction o

Первичные конечные точки

• Proportion of participants with Hypertension Remission [Срок оценки: up to 24 weeks]

Вторичные конечные точки (11)

• Change in antihypertensive pharmacological load [Срок оценки: Baseline and week 24]
• Proportion of participants with antihypertensive dose modification [Срок оценки: Baseline and week 24]
• Change in systolic blood pressure [Срок оценки: Baseline, week 12 and week 24]
• Change in diastolic blood pressure [Срок оценки: Baseline, week 12 and week 24]
• Change in body mass index (BMI) [Срок оценки: Baseline, week 12 and week 24]
• Change in low-density lipoprotein cholesterol concentration (LDL-C) [Срок оценки: Baseline, week 12 and week 24]
• Change in glycated hemoglobin (HbA1c) percentage [Срок оценки: Baseline, week 12 and week 24]
• Change in the total score of the Simple Lifestyle Indicator Questionnaire (SLIQ) [Срок оценки: Baseline and week 24]
• Number of participants with Adverse Events (AE) [Срок оценки: up to 24 weeks]
• Number of participants with Serious Adverse Events (SAE) [Срок оценки: up to 24 weeks]
• Number of Participants with High Hemodynamic Response Indicator (HHRI) [Срок оценки: up to 24 weeks]

Критерии участия

Inclusion Criteria <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> Exclusion Criteria <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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Аргентина · 1 центр

• Universidad Abierta Interamericana — Buenos Aires

Идентификаторы

NCT: NCT07424118 · REMIDEP-HTA · IS005153

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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