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

NCT07441304 | Completed

• 1 other identifier: AT-HOM
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Severe Obesity Scheduled for Bariatric Surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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.

Study Arms (1)

severe obesity scheduled for bariatric surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with severe obesity scheduled for bariatric surgery.

You may qualify if:

• 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

You may not qualify if:

• Absence of arterial hypertension
• No current antihypertensive pharmacotherapy
• Inability to provide informed consent
• Pregnancy

Sponsors & Collaborators

• Universität des Saarlandes: lead

Study Sites (1)

Universitätsklinikum des Saarlandes

Homburg, 66421, Germany

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2026
• First Posted: February 27, 2026
• Study Start: August 4, 2022
• Primary Completion: November 26, 2024
• Study Completion: November 21, 2025
• Last Updated: February 27, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)