Severe Obesity Scheduled for Bariatric Surgery
Conditions
Brief summary
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.
Interventions
None listed
Sponsors
Universität des Saarlandes
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥18 years * 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) * Documented diagnosis of arterial hypertension * Ongoing pharmacological antihypertensive therapy at the time of screening * Ability to provide written informed consent
Exclusion criteria
* Absence of arterial hypertension * No current antihypertensive pharmacotherapy * Inability to provide informed consent * Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adherence to antihypertensive therapy | 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. | \- 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 \- 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Control of cardiovascular risk factors | 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. | — |
| Prescription rate of guideline-directed medical therapy | 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. | 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. |
Countries
Germany
Outcome results
None listed