Cardiometabolic Risk Factor Management and Adherence to Antihypertensive Therapy in Patients With Severe Obesity Prior to Bariatric Surgery: a Prospective Longitudinal Cohort Study

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.

Study Overview

• Status: Completed
• Conditions: Severe Obesity Scheduled for Bariatric Surgery

• Study Type: Observational
• Enrollment (Actual): 80

Contacts and Locations

Study Locations

• Germany
  • Homburg, Germany, 66421
    • Universitatsklinikum des Saarlandes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with severe obesity scheduled for bariatric surgery.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
severe obesity scheduled for bariatric surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adherence to antihypertensive therapy	- 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.	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.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	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.

Collaborators and Investigators

• Sponsor: Universität des Saarlandes

Study record dates

Study Major Dates

• Study Start (Actual): August 4, 2022
• Primary Completion (Actual): November 26, 2024
• Study Completion (Actual): November 21, 2025

Study Registration Dates

• First Submitted: January 29, 2026
• First Submitted That Met QC Criteria: February 24, 2026
• First Posted (Actual): February 27, 2026

Study Record Updates

• Last Update Posted (Actual): February 27, 2026
• Last Update Submitted That Met QC Criteria: February 24, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: AT-HOM

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No