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REMIDEP-HTA Program for Hypertension Remission and Medication Deprescription

ConditionEssential Hypertension
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-65
SponsorEvelyn Vanina Re

About this trial

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.

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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.

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • Pharmacological Deprescribing Algorithm

    Other intervention

    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 Care

    Other intervention

    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.

Treatment groups

240 Participants
are divided into 2 treatment groups
Group A: Intervention GroupExperimental treatment 2 interventions
Group B: Control GroupActive comparator 1 intervention

Trial outcomes

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.

Time frame
up to 24 weeks

Secondary outcomes

1

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
2

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
3

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.

Time frame
Baseline, week 12 and week 24
4

Change in diastolic blood pressure

Change from baseline in diastolic 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.

Time frame
Baseline, week 12 and week 24

Other outcomes

1

Change in total cholesterol concentration

Change from baseline in total cholesterol concentration, expressed in milligrams per deciliter (mg/dL), measured from a 12-hour fasting venous blood sample using standardized laboratory methods.

Time frame
Baseline, Week 12 and Week 24
2

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

Change from baseline in high-density lipoprotein cholesterol concentration, expressed in milligrams per deciliter (mg/dL), measured from a 12-hour fasting venous blood sample using standardized laboratory methods.

Time frame
Baseline, Week 12 and Week 24
3

Change in triglyceride concentration

Change from baseline in triglyceride concentration, expressed in milligrams per deciliter (mg/dL), measured from a 12-hour fasting venous blood sample using standardized laboratory methods.

Time frame
Baseline, Week 12 and Week 24
4

Change in fasting plasma glucose concentration

Change from baseline in fasting plasma glucose concentration, expressed in milligrams per deciliter (mg/dL), measured from a 12-hour fasting venous blood sample using standardized laboratory methods.

Time frame
Baseline, Week 12 and Week 24

Locations

1

Map coordinates are unavailable for these locations. Locations are shown below instead.

Universidad Abierta Interamericana Status unavailable C1147AAU, Buenos Aires, Buenos AiresArgentinaArgentina

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Evelyn Vanina Re

Lead sponsor

Universidad Abierta Interamericana

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: