REMIDEP-HTA Program for Hypertension Remission and Medication Deprescription

NCT07424118 | Not Yet Recruiting DMC

• 2 other identifiers: REMIDEP-HTAIS005153
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Essential Hypertension

Keywords

Hypertension; Remission; Lifestyle Medicine; REMIDEP-HTA; Deprescribing Algorithm

Outcome Measures

Primary Outcomes (1)

• 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.

  up to 24 weeks

Secondary Outcomes (11)

• 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

Other Outcomes (5)

• Change in total cholesterol concentration

  Baseline, Week 12 and Week 24

• Change in high-density lipoprotein cholesterol concentration (HDL-C)

  Baseline, Week 12 and Week 24

• Change in triglyceride concentration

  Baseline, Week 12 and Week 24

Study Arms (2)

Intervention Group

EXPERIMENTAL

REMIDEP-HTA Program: Intensive Lifestyle and Structured Deprescribing

Behavioral: Intensive Lifestyle Intervention; Other: Pharmacological Deprescribing Algorithm

Control Group

ACTIVE COMPARATOR

Standard Hypertension Care (American Heart Association/American College of Cardiology 2025 Guidelines \[AHA/ACC\])

Other: Standard Medical Care

Interventions

Intensive Lifestyle Intervention BEHAVIORAL

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.

Also known as: Therapeutic Lifestyle Intervention (TLI), Programa de Estilo de Vida, Intervención Terapeútica de Estilo de Vida (ITEV)

Intervention Group

Pharmacological Deprescribing Algorithm OTHER

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.

Also known as: Antihypertensive Deprescribing Algorithm, Structured Antihypertensive Withdrawal Protocol, Algoritmo de Deprescripción

Intervention Group

Standard Medical Care OTHER

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.

Also known as: Standard of Care, Manejo Clínico Habitual

Control Group

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \<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.

You may not qualify if:

• \<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.

Sponsors & Collaborators

• Evelyn Vanina Re: lead

Study Sites (1)

Universidad Abierta Interamericana

Buenos Aires, Buenos Aires, C1147AAU, Argentina

Location

MeSH Terms

Conditions

Essential Hypertension; Hypertension

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Evelyn V Re, MD

  Universidad Abierta Interamericana

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Evelyn V Re, MD

CONTACT

(+54) 11 4363-3500; evelynvanina.re@uai.edu.ar

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Physician, Cardiologist

Model Details: Multicenter, parallel-group, randomized clinical trial with a 1:1 allocation ratio. The study utilizes a Prospective Randomized Open, Blinded End-point (PROBE) design to ensure objectivity in outcome adjudication. Randomization is centralized and performed via the Research Electronic Data Capture (REDCap) platform using permuted blocks, stratified by research site to ensure group balance within each participating institution.

Study Record Dates

• First Submitted: February 5, 2026
• First Posted: February 20, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 20, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: De-identified individual participant data will be available beginning at the time of publication of the primary study results and for 3 years thereafter, subject to applicable ethical, institutional, and regulatory requirements.
• Access Criteria: De-identified individual participant data and supporting documents will be available to other researchers upon reasonable request. Access will be granted following submission of a data request to the Principal Investigator using the contact information provided in this registry, execution of an appropriate data use agreement, and compliance with applicable ethical, institutional, and regulatory requirements. Data will be shared in a manner that ensures protection of participant confidentiality.

Locations

AR (1)