NCT07424118

REMIDEP-HTA Program for Hypertension Remission and Medication Deprescription

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 240 (estimated)
• Sponsor: Evelyn Vanina Re · Academic / Other
• Sex: All
• Age: 40 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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).

Conditions

• Essential Hypertension

Interventions

Type	Name	Description
BEHAVIORAL	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.
OTHER	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 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.
OTHER	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 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.

Timeline

• Start date: 2026-04-01
• Primary completion: 2026-11-01
• Completion: 2026-12-01
• First posted: 2026-02-20
• Last updated: 2026-02-20

Locations

1 site across 1 country: Argentina