Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-30 @ 12:13 AM
Study NCT ID:
NCT07441304
Status:
COMPLETED
Last Update Posted:
2026-02-27
First Post:
2026-01-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cardiometabolic Risk Factor Management and Adherence to Antihypertensive Therapy in Patients With Severe Obesity Prior to Bariatric Surgery: a Prospective Longitudinal Cohort Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-08-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2025-11-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-02-24', 'studyFirstSubmitDate': '2026-01-29', 'studyFirstSubmitQcDate': '2026-02-24', 'lastUpdatePostDateStruct': {'date': '2026-02-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adherence to antihypertensive therapy', 'timeFrame': 'Visit 1-3 : Up to 12 months (+/- 3 months) pre-op; Visit 4: -1day pre-op; Visit 5: +1d post op; Visit 6: +3 d post-op; Visit 7: +5vd post-op; Visit 8: 90 +/- 30 days post-op.', 'description': '\\- Medication adherence to antihypertensive therapy (multi-tiered definition): assessed by combining structured self-report with objective plasma drug detection: x Adherent: All prescribed antihypertensive drugs detectable in plasma x Partially adherent: One prescribed antihypertensive drug not detectable x Non-adherent: Self-reported non-adherence, or two or more prescribed antihypertensive drugs not detectable, or antihypertensive monotherapy with the single prescribed drug not detectable\n\n\\- Longitudinal adherence assessment to antihypertensive therapy: repeated adherence evaluations performed across up to eight study visits using the same combined self-report and toxicological approach.'}], 'secondaryOutcomes': [{'measure': 'Control of cardiovascular risk factors', 'timeFrame': 'Visit 1-3 : Up to 12 months (+/- 3 months) pre-op; Visit 4: -1day pre-op; Visit 5: +1d post op; Visit 6: +3 d post-op; Visit 7: +5vd post-op; Visit 8: 90 +/- 30 days post-op.'}, {'measure': 'Prescription rate of guideline-directed medical therapy', 'timeFrame': 'Visit 1-3 : Up to 12 months (+/- 3 months) pre-op; Visit 4: -1day pre-op; Visit 5: +1d post op; Visit 6: +3 d post-op; Visit 7: +5vd post-op; Visit 8: 90 +/- 30 days post-op.', 'description': 'Guideline-directed medical therapy (GDMT) for hypertension: Prescription of a combination therapy consisting of ≥2 different antihypertensive drug classes recommended as first-line treatment, including: Angiotensin-converting enzyme inhibitors (ACE inhibitors) or angiotensin II receptor blockers (AT1 blockers), calcium channel blockers, diuretics, beta-blockers (accepted when indicated due to intolerance to other agents or specific clinical indications such as atrial fibrillation, heart failure, or prior myocardial infarction); the combined use of ACE inhibitors and AT1 blockers is considered non-guideline-concordant, use of single-pill combinations is recommended but not mandatory for GDMT.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Severe Obesity Scheduled for Bariatric Surgery']}, 'descriptionModule': {'briefSummary': 'Patients with severe obesity frequently exhibit elevated cardiovascular risk. Contributing factors could be inadequate recognition and subsequent management of cardiovascular risk factors, and non-adherence to cardiovascular therapy. This prospective longitudinal cohort study aims to systematically assess the management of major cardiovascular risk factors and objectively evaluate adherence to antihypertensive therapy in patients with severe obesity undergoing evaluation for bariatric surgery. Using repeated assessments and direct plasma drug detection, the study seeks to characterise adherence patterns over time and identify clinical factors associated with persistent non-adherence.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with severe obesity scheduled for bariatric surgery.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥18 years\n* Severe obesity with an indication for bariatric surgery (body mass index ≥40 kg/m², or body mass index ≥35 kg/m² with obesity-associated cardiovascular risk factors)\n* Documented diagnosis of arterial hypertension\n* Ongoing pharmacological antihypertensive therapy at the time of screening\n* Ability to provide written informed consent\n\nExclusion Criteria:\n\n* Absence of arterial hypertension\n* No current antihypertensive pharmacotherapy\n* Inability to provide informed consent\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT07441304', 'briefTitle': 'Cardiometabolic Risk Factor Management and Adherence to Antihypertensive Therapy in Patients With Severe Obesity Prior to Bariatric Surgery: a Prospective Longitudinal Cohort Study', 'organization': {'class': 'OTHER', 'fullName': 'Universität des Saarlandes'}, 'officialTitle': 'Cardiometabolic Risk Factor Management and Adherence to Antihypertensive Therapy in Patients With Severe Obesity Prior to Bariatric Surgery: a Prospective Longitudinal Cohort Study', 'orgStudyIdInfo': {'id': 'AT-HOM'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'severe obesity scheduled for bariatric surgery'}]}, 'contactsLocationsModule': {'locations': [{'zip': '66421', 'city': 'Homburg', 'country': 'Germany', 'facility': 'Universitätsklinikum des Saarlandes', 'geoPoint': {'lat': 49.32637, 'lon': 7.33867}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universität des Saarlandes', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}