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Essential HypertensionREMIDEP-HTANCT07424118

REMIDEP-HTA Program for Hypertension Remission and Medication Deprescription

A study testing Intensive Lifestyle Intervention, Pharmacological Deprescribing Algorithm and Standard Medical Care in people with Essential Hypertension, run by Evelyn Vanina Re at 1 site in Argentina.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 40 to 65 years
Conditions the study is for
Essential Hypertension
What is being tested?
Intensive Lifestyle Intervention, Pharmacological Deprescribing Algorithm and Standard Medical Care
Could I receive a placebo?
No, everyone receives an active treatment
How many people
240 participants
Where
1 siteArgentina
Study dates
Apr 2026to Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Argentina1 site
  • Universidad Abierta Interamericana

    Buenos Aires, Buenos Aires, C1147AAU

    Evelyn V Re, MD, (+54) 11 4363-3500, evelynvanina.re@uai.edu.ar

    Evelyn V Re, MD

Other trials in Argentina

About this study

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

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.

Read the 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.

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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.

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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.

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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.

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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.

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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).

Being tested
Intensive Lifestyle Intervention, Pharmacological Deprescribing Algorithm, Standard Medical Care
Keywords
Hypertension, Remission, Lifestyle Medicine, REMIDEP-HTA, Deprescribing Algorithm
Medical subject headings
Essential Hypertension, Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Intensive Lifestyle InterventionBehavioural

    Also called Therapeutic Lifestyle Intervention (TLI), Programa de Estilo de Vida, Intervención Terapeútica de Estilo de Vida (ITEV)

    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

    Also called Antihypertensive Deprescribing Algorithm, Structured Antihypertensive Withdrawal Protocol, Algoritmo de Deprescripción

    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

    Also called Standard of Care, Manejo Clínico Habitual

    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.

Study groups in NCT07424118
Study groupRoleWhat they receive
Intervention GroupExperimentalREMIDEP-HTA Program: Intensive Lifestyle and Structured Deprescribing
Receives: Behavioral: Intensive Lifestyle Intervention; Other: Pharmacological Deprescribing Algorithm
Control GroupActive comparatorStandard Hypertension Care (American Heart Association/American College of Cardiology 2025 Guidelines [AHA/ACC])
Receives: Other: Standard Medical Care

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: up to 24 weeks

Secondary outcomes (11)
  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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: Baseline, week 12 and week 24

  5. Change in body mass index (BMI)

    Change from baseline in body mass index (BMI), calculated as weight in kilograms divided by height in meters squared (kg/m²).

    Measured: Baseline, week 12 and week 24

  6. Change in low-density lipoprotein cholesterol concentration (LDL-C)

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

    Measured: Baseline, week 12 and week 24

  7. Change in glycated hemoglobin (HbA1c) percentage

    Change from baseline in glycated hemoglobin concentration (HbA1c), expressed as percentage (%), measured from a 12-hour fasting venous blood sample using standardized laboratory methods.

    Measured: Baseline, week 12 and week 24

  8. Change in the total score of the Simple Lifestyle Indicator Questionnaire (SLIQ)

    Change from baseline in the total score of the Simple Lifestyle Indicator Questionnaire (SLIQ). The total score ranges from 0 to 10 and is calculated by summing five component scores, where 0 represents the least healthy lifestyle and 10 the most healthy lifestyle.

    Measured: Baseline and week 24

  9. Number of participants with Adverse Events (AE)

    Number and proportion of participants experiencing at least one clinically documented adverse event (AE), including the following prespecified events: new-onset edema (Godet sign ≥ 2 not present at baseline); new-onset arrhythmias documented by electrocardiogram (ECG); hypertensive crisis defined as blood pressure (BP) ≥ 180/110 millimeters of mercury (mmHg); new-onset angina; new-onset dyspnea on exertion classified as New York Heart Association (NYHA) Functional Class II or higher; or any other medically significant event requiring clinical intervention or modification of the study protocol.

    Measured: up to 24 weeks

  10. Number of participants with Serious Adverse Events (SAE)

    Number and proportion of participants experiencing at least one clinically documented serious adverse event (SAE), including to acute myocardial ischemia (including myocardial infarction or unstable angina), acute pulmonary edema, cerebrovascular accident (ischemic or hemorrhagic stroke or transient ischemic attack), or any other medical occurrence that results in death, is life-threatening, requires inpatient hospitalization, results in persistent or significant disability, or is considered a medically important event.

    Measured: up to 24 weeks

  11. Number of Participants with High Hemodynamic Response Indicator (HHRI)

    Number and proportion of participants experiencing at least one High Hemodynamic Response Indicator (HHRI) episode, defined as systolic blood pressure (SBP) < 100 millimeters of mercury (mmHg) and/or diastolic blood pressure (DBP) < 60 millimeters of mercury (mmHg) requiring medical intervention for pharmacological dose adjustment or reduction. Each episode is documented together with the presence or absence of the following clinical manifestations: dizziness or instability; unusual fatigue or weakness; blurred vision; syncope or presyncope; or other medically specified symptom associated with the hypotensive episode

    Measured: up to 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Feb 2026
  2. Study startApr 2026 (estimated)
  3. Primary completionNov 2026 (estimated)
  4. Study completionDec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
240 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07424118
Sponsor's protocol ID
REMIDEP-HTA
Other IDs
IS005153
Acronym
REMIDEP-HTA
Status last verified
Feb 2026
First submitted
5 Feb 2026
Last updated
20 Feb 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De-identified individual participant data (IPD) underlying the primary and secondary outcome measures will be shared. This includes individual-level data related to blood pressure measurements, antihypertensive medication use, key clinical and demographic variables, and other data necessary to reproduce the main analyses reported in the final publication. Data sharing will be conducted upon reasonable request, subject to appropriate data use agreements and in accordance with applicable ethical, institutional, and regulatory requirements, with safeguards in place to protect participant confidentiality. Requests should be directed to the Principal Investigator using the contact information provided in this registry.

Questions about this trial

What is this clinical trial studying?

A study testing Intensive Lifestyle Intervention, Pharmacological Deprescribing Algorithm and Standard Medical Care in people with Essential Hypertension, run by Evelyn Vanina Re at 1 site in Argentina.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 20 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Evelyn V Re, MD ((+54) 11 4363-3500, evelynvanina.re@uai.edu.ar), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of participants with Hypertension Remission (time frame: up to 24 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2026.

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