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NCT07424118

REMIDEP-HTA Program for Hypertension Remission and Medication Deprescription

Sponsor: Evelyn Vanina Re

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

40 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

240

Start Date

2026-04

Completion Date

2026-12

Last Updated

2026-02-20

Healthy Volunteers

Conditions

Essential Hypertension

Interventions

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.

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.

Locations (1)

Universidad Abierta Interamericana

Buenos Aires, Buenos Aires, Argentina