REMIDEP-HTA Program for Hypertension Remission and Medication Deprescription

N/ANot Yet RecruitingNCT07424118

Evelyn Vanina Re240 enrolled

Overview

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.

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. \<br\>\<br\> 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. \<br\>\<br\> 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. \<br\>\<br\> 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. \<br\>\<br\> 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. \<br\>\<br\> 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).

Interventions

Intensive Lifestyle InterventionBEHAVIORAL

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.

Pharmacological Deprescribing AlgorithmOTHER

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 cardioprotection, and the risk of withdrawal syndromes. Clinical adjustments are guided by a predefined traffic-light conduct model supported by home blood pressure monitoring. Rescue coaching sessions are implemented when predefined blood pressure thresholds are exceeded to support hemodynamic stability during the tapering process.

Standard Medical CareOTHER

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 or medication suspension, are performed exclusively based on the clinical judgment and autonomy of the treating physician and the standard of care, without the use of a structured algorithm. At baseline, participants receive a standardized educational brochure summarizing general healthy lifestyle recommendations consistent with the guideline. No components of the REMIDEP-HTA standardized intervention program are applied to this group.

Eligibility

Sex: ALLMin age: 40 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Proportion of participants with Hypertension Remission

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.

Time frame: up to 24 weeks

Secondary Outcomes

Change in antihypertensive pharmacological load

Pharmacological load is defined as the total number of antihypertensive active ingredients in the treatment regimen. Fixed-dose combinations are counted by their individual components. The outcome is calculated as the proportion of active ingredients discontinued at Week 24 relative to the number recorded at baseline.

Time frame: Baseline and week 24

Proportion of participants with antihypertensive dose modification

Dose modification is defined as any effective reduction in baseline pharmacological treatment intensity, either by dose reduction of at least one antihypertensive medication or complete discontinuation of at least one active ingredient. The outcome is assessed at Week 24 in comparison with baseline.

Time frame: Baseline and week 24

Change in systolic blood pressure

Change from baseline in systolic blood pressure, expressed in millimeters of mercury (mmHg), at Weeks 12 and 24, assessed using standardized office measurements (average of the 2nd and 3rd readings after 5 minutes of rest) and protocol-defined home blood pressure monitoring averages obtained with validated devices.