Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-04-01 @ 5:34 PM
Study NCT ID:
NCT07424118
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-20
First Post:
2026-02-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
REMIDEP-HTA Program for Hypertension Remission and Medication Deprescription
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000075222', 'term': 'Essential Hypertension'}, {'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D059039', 'term': 'Standard of Care'}], 'ancestors': [{'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': '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.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 240}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-04', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-13', 'studyFirstSubmitDate': '2026-02-05', 'studyFirstSubmitQcDate': '2026-02-13', 'lastUpdatePostDateStruct': {'date': '2026-02-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change in total cholesterol concentration', 'timeFrame': 'Baseline, Week 12 and Week 24', 'description': '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.'}, {'measure': 'Change in high-density lipoprotein cholesterol concentration (HDL-C)', 'timeFrame': 'Baseline, Week 12 and Week 24', 'description': '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.'}, {'measure': 'Change in triglyceride concentration', 'timeFrame': 'Baseline, Week 12 and Week 24', 'description': '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.'}, {'measure': 'Change in fasting plasma glucose concentration', 'timeFrame': 'Baseline, Week 12 and Week 24', 'description': '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.'}, {'measure': 'Change in apolipoprotein B-100 concentration (ApoB-100)', 'timeFrame': 'Baseline, Week 12 and Week 24', 'description': 'Change from baseline in apolipoprotein B-100 concentration, expressed in milligrams per deciliter (mg/dL), measured from a 12-hour fasting venous blood sample using standardized laboratory methods.'}], 'primaryOutcomes': [{'measure': 'Proportion of participants with Hypertension Remission', 'timeFrame': 'up to 24 weeks', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Change in antihypertensive pharmacological load', 'timeFrame': 'Baseline and week 24', 'description': '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.'}, {'measure': 'Proportion of participants with antihypertensive dose modification', 'timeFrame': 'Baseline and week 24', 'description': '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.'}, {'measure': 'Change in systolic blood pressure', 'timeFrame': 'Baseline, week 12 and week 24', 'description': '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.'}, {'measure': 'Change in diastolic blood pressure', 'timeFrame': 'Baseline, week 12 and week 24', 'description': '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.'}, {'measure': 'Change in body mass index (BMI)', 'timeFrame': 'Baseline, week 12 and week 24', 'description': 'Change from baseline in body mass index (BMI), calculated as weight in kilograms divided by height in meters squared (kg/m²).'}, {'measure': 'Change in low-density lipoprotein cholesterol concentration (LDL-C)', 'timeFrame': 'Baseline, week 12 and week 24', 'description': '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.'}, {'measure': 'Change in glycated hemoglobin (HbA1c) percentage', 'timeFrame': 'Baseline, week 12 and week 24', 'description': 'Change from baseline in glycated hemoglobin concentration (HbA1c), expressed as percentage (%), measured from a 12-hour fasting venous blood sample using standardized laboratory methods.'}, {'measure': 'Change in the total score of the Simple Lifestyle Indicator Questionnaire (SLIQ)', 'timeFrame': 'Baseline and week 24', 'description': '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.'}, {'measure': 'Number of participants with Adverse Events (AE)', 'timeFrame': 'up to 24 weeks', 'description': '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.'}, {'measure': 'Number of participants with Serious Adverse Events (SAE)', 'timeFrame': 'up to 24 weeks', 'description': '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.'}, {'measure': 'Number of Participants with High Hemodynamic Response Indicator (HHRI)', 'timeFrame': 'up to 24 weeks', 'description': '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'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hypertension', 'Remission', 'Lifestyle Medicine', 'REMIDEP-HTA', 'Deprescribing Algorithm'], 'conditions': ['Essential Hypertension']}, 'descriptionModule': {'briefSummary': '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.\n\n\\<br\\>\\<br\\>\n\nThe 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.\n\n\\<br\\>\\<br\\>\n\nThe study aims to determine whether remission can be achieved through a standardized and monitored strategy that prioritizes clinical safety during medication withdrawal.', 'detailedDescription': '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.\n\n\\<br\\>\\<br\\>\n\nHypertension 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.\n\n\\<br\\>\\<br\\>\n\nParticipants 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.\n\n\\<br\\>\\<br\\>\n\nThe 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.\n\n\\<br\\>\\<br\\>\n\nMedication 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.\n\n\\<br\\>\\<br\\>\n\nSafety 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).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "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.\n\n\\<br\\>\\<br\\> Stable antihypertensive pharmacological treatment for at least 3 months prior to enrollment, with no changes in medications or dosages.\n\n\\<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.\n\n\\<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.\n\n\\<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.\n\n\\<br\\>\\<br\\> Medical conditions requiring mandatory continuation of antihypertensive therapy for indications other than blood pressure control, precluding medication reduction or withdrawal.\n\n\\<br\\>\\<br\\> Physical limitation preventing participation in light-to-moderate intensity physical activity.\n\n\\<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.\n\n\\<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.\n\n\\<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."}, 'identificationModule': {'nctId': 'NCT07424118', 'acronym': 'REMIDEP-HTA', 'briefTitle': 'REMIDEP-HTA Program for Hypertension Remission and Medication Deprescription', 'organization': {'class': 'OTHER', 'fullName': 'Universidad Abierta Interamericana'}, 'officialTitle': 'Efficacy of the REMIDEP-HTA Program in Hypertension Remission and Pharmacological Deprescription: A Multicenter Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'REMIDEP-HTA'}, 'secondaryIdInfos': [{'id': 'IS005153', 'type': 'REGISTRY', 'domain': 'National Registry of Health Research (RENIS), Argentina'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention Group', 'description': 'REMIDEP-HTA Program: Intensive Lifestyle and Structured Deprescribing', 'interventionNames': ['Behavioral: Intensive Lifestyle Intervention', 'Other: Pharmacological Deprescribing Algorithm']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control Group', 'description': 'Standard Hypertension Care (American Heart Association/American College of Cardiology 2025 Guidelines \\[AHA/ACC\\])', 'interventionNames': ['Other: Standard Medical Care']}], 'interventions': [{'name': 'Intensive Lifestyle Intervention', 'type': 'BEHAVIORAL', 'otherNames': ['Therapeutic Lifestyle Intervention (TLI)', 'Programa de Estilo de Vida', 'Intervención Terapeútica de Estilo de Vida (ITEV)'], 'description': '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.', 'armGroupLabels': ['Intervention Group']}, {'name': 'Pharmacological Deprescribing Algorithm', 'type': 'OTHER', 'otherNames': ['Antihypertensive Deprescribing Algorithm', 'Structured Antihypertensive Withdrawal Protocol', 'Algoritmo de Deprescripción'], 'description': '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.\n\nMedication 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.', 'armGroupLabels': ['Intervention Group']}, {'name': 'Standard Medical Care', 'type': 'OTHER', 'otherNames': ['Standard of Care', 'Manejo Clínico Habitual'], 'description': '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.', 'armGroupLabels': ['Control Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'C1147AAU', 'city': 'Buenos Aires', 'state': 'Buenos Aires', 'country': 'Argentina', 'contacts': [{'name': 'Evelyn V Re, MD', 'role': 'CONTACT', 'email': 'evelynvanina.re@uai.edu.ar', 'phone': '(+54) 11 4363-3500'}, {'name': 'Evelyn V Re, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Universidad Abierta Interamericana'}], 'centralContacts': [{'name': 'Evelyn V Re, MD', 'role': 'CONTACT', 'email': 'evelynvanina.re@uai.edu.ar', 'phone': '(+54) 11 4363-3500'}], 'overallOfficials': [{'name': 'Evelyn V Re, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universidad Abierta Interamericana'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': '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.', 'ipdSharing': 'YES', 'description': '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.', 'accessCriteria': '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.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Evelyn Vanina Re', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Physician, Cardiologist', 'investigatorFullName': 'Evelyn Vanina Re', 'investigatorAffiliation': 'Universidad Abierta Interamericana'}}}}