Severe Obesity Scheduled for Bariatric SurgeryNCT07441304
Cardiometabolic Risk Factor Management and Adherence to Antihypertensive Therapy in Patients With Severe Obesity Prior to Bariatric Surgery: a Prospective Longitudinal Cohort Study
An observational study of Severe Obesity Scheduled for Bariatric Surgery, run by Universität des Saarlandes at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Severe Obesity Scheduled for Bariatric Surgery
- How many people
- 80 participants
- Where
- 1 siteGermany
- Study dates
- 4 Aug 2022to 21 Nov 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with severe obesity scheduled for bariatric surgery.
Who may be able to join
- 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
Who cannot join
- Absence of arterial hypertension
- No current antihypertensive pharmacotherapy
- Inability to provide informed consent
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this 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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| severe obesity scheduled for bariatric surgery | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start4 Aug 2022
- Primary completion26 Nov 2024
- Study completion21 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe Obesity Scheduled for Bariatric SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universität des Saarlandes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07441304
- Sponsor's protocol ID
- AT-HOM
- Status last verified
- Jan 2026
- First submitted
- 29 Jan 2026
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiometabolic Risk Factor Management and Adherence to Antihypertensive Therapy in Patients With Severe Obesity Prior to Bariatric Surgery: a Prospective Longitudinal Cohort Study
- ClinicalTrials.gov ID
- NCT07441304
- Acronym / sponsor ID
- AT-HOM
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Universität des SaarlandesUniversity, hospital or other
- Study start
- 4 Aug 2022 (actual)
- Primary completion
- 26 Nov 2024 (actual)
- Study completion
- 21 Nov 2025 (actual)
- First posted
- 27 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| severe obesity scheduled for bariatric surgery | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with severe obesity scheduled for bariatric surgery.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- Absence of arterial hypertension
- No current antihypertensive pharmacotherapy
- Inability to provide informed consent
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Adherence to antihypertensive therapy
Time frame: 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.
2 secondary outcomes
Control of cardiovascular risk factors
Time frame: 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
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Severe Obesity Scheduled for Bariatric Surgery, run by Universität des Saarlandes at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence to antihypertensive therapy (time frame: 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.