HypertensionAntitensionNCT06823570
Anti-hypertensive Therapy and Exercise Treatment to Improve Vascular Health in Patients With Hypertension.
A study testing Individualized exercise therapy and Lifestyle recommendations in people with Hypertension and Vascular Function, run by Heinrich-Heine University, Duesseldorf at 1 site in Germany.
Trial summary
This is a prospective, monocentric, randomized controlled trial to investigate the effect of anti-hypertensive treatment and/or individualized exercise training intervention on blood pressure and vascular health. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension, Vascular Function, Fitness Testing
- What is being tested?
- Individualized exercise therapy and Lifestyle recommendations
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteGermany
- Study dates
- 1 Apr 2025to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- systolic hypertension grade I-II (BP values >140 mmHg to <180 mmHg) without anti-hypertensive medication treatment
Who cannot join
- no written informed consent
- age <18 years
- isolated diastolic hypertension
- medical contraindications for the exercise treatment (for example orthopedic problems or an abnormal ECG during the cardio respiratory exercise test)
- chronic eye diseases on both eyes (for example macular degeneration or glaucoma) or high intraocular pressure (>20 mmHg)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Johannes Stegbauer, Prof. Dr. contact
Lukas Streese, PhD contact
Germany1 site, 1 recruiting
- Recruiting
Universitätsklinik Düsseldorf
Düsseldorf, Düsseldorf, 40225
Lukas Streese, PhD, +49 211 81 080 74, Studienzentrum-Nephrologie@med.uni-duesseldorf.de
Johannes Stegbauer, MD
About this study
Official title: Anti-hypertensive Therapy and Exercise Treatment to Improve Vascular Health in Patients With Hypertension. A Randomized Controlled Trial.
This is a prospective, monocentric, randomized controlled trial to investigate the effect of anti-hypertensive treatment and/or individualized exercise training intervention on blood pressure and vascular health. Furthermore the investigators want to decipher mechanisms, which contribute to vascular health by analyzing changes in metabolism and cell function in relation to vascular reaction.
Read the detailed description
Arterial hypertension is a global health burden that affects the structure and function of large and small blood vessels and induces disease-specific end-organ damage. Exercise therapy is highly recommended in the treatment of arterial hypertension to reduce blood pressure and ameliorate hypertension-induced vascular damage. Previous exercise intervention studies have shown that exercise treatment improves vascular dysfunction independently of changes in blood pressure. Several sensitive vascular biomarkers exist that could optimize risk stratification and therapeutic decisions based on the progression of individual vascular damage in patients with arterial hypertension. However, individualized vascular assessment during anti-hypertensive treatment is not yet part of routine clinical practice. In order to improve clinical decision making from a personalized medicine perspective, it is essential to better understand which vascular biomarkers have the best sensitivity in detecting therapy-induced vascular adaptations and whether anti-hypertensive therapy with or without additional exercise improves vascular health in patients with hypertension. The proposed study will evaluate the effects of guideline-directed anti-hypertensive therapy with or without individualized exercise training intervention in 60 patients with hypertension and no previous medical treatment for one year. Regular outpatient assessments of blood pressure and large and small blood vessels will be performed every two months. Anti-hypertensive therapy will be based on the current guidelines of the European Society of Hypertension. The investigators aim to achieve the target blood pressure after six months of treatment. A further six-month follow-up is planned to assess the long-term effects of anti-hypertensive therapy, with or without additional individualized exercise training intervention, on blood pressure and macro- and microvascular health. In addition, the investigators will investigate the effect of metabolic changes induced by anti-hypertensive treatment or individualized exercise training intervention on vascular health.
- Conditions
- Hypertension, Vascular Function, Fitness Testing, Metabolism Changes
- Being tested
- Individualized exercise therapy, Lifestyle recommendations
- Keywords
- cardiorespiratory fitness, retinal microcirculation, endothelial function, exercise training, lifestyle treatment
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individualized exercise therapyBehavioural
Patients in the intervention group will receive an individualized exercise training program 3x/week.
Lifestyle recommendationsBehavioural
The lifestyle recommendation group will receive general recommendations such as salt reduction, higher physical activity levels and stress reduction.
| Study group | Role | What they receive |
|---|---|---|
| Individualized exercise training group | Active comparator | Beside a guideline based anti-hypertensive therapy, patients in the intervention group will receive an individualized exercise training program 3x/week. Exercise training will be a combination of aerobic and resistance training and is based on each patient's individual fitness level. Regular contact between exercise physiologists and patients, as well as group sessions, will help patients to maintain a regular exercise program. Receives: Behavioral: Individualized exercise therapy; Behavioral: Lifestyle recommendations |
| Control group | Other | Beside a guideline based anti-hypertensive therapy, patients in the lifestyle recommendation group will receive general recommendations such as salt reduction, higher physical activity levels and stress reduction. Receives: Behavioral: Lifestyle recommendations |
What is being measured
The primary outcome is the main question the study is designed to answer.
The additional effect of an anti-hypertensive treatment plus an individualizes exercise therapy on the retinal vessel diameters compared to a guideline based anti-hypertensive treatment with general lifestyle recommendations.
The retinal vessel diameters will be analyzed based on the arteriolar-to-venular diameter ratio (AVR).
Measured: From enrollment to the end of treatment after six month.
Effect of an guideline based anti-hypertensive therapy on the retinal vessel diameters.
Changes of retinal vessel diameters will be analyzed based on the arteriolar-to-venular diameter ratio (AVR).
Measured: From enrollment to the end of treatment after six month.
Secondary outcomes (14)
The additional effect of an anti-hypertensive treatment plus an individualizes exercise therapy on the systolic and diastolic blood pressure compared to a guideline based anti-hypertensive treatment with general lifestyle recommendations.
Changes in unattended systolic and diastolic blood pressure in mm Hg.
Measured: From enrollment to the end of treatment after six month.
Effect of an guideline based anti-hypertensive therapy on the systolic and diastolic blood pressure.
Changes in unattended systolic and diastolic blood pressure in mm Hg.
Measured: From enrollment to the end of treatment after six month.
The additional effect of an anti-hypertensive treatment plus an individualizes exercise therapy on the microvascular endothelial function compared to a guideline based anti-hypertensive treatment with general lifestyle recommendations.
Changes in microvascular endothelial function will be analyzed by retinal arteriolar and venular flicker light-induced dilation.
Measured: From enrollment to the end of treatment after six month.
Effect of an guideline based anti-hypertensive therapy on the microvascular endothelial function.
Changes in microvascular endothelial function will be analyzed by retinal arteriolar and venular flicker light-induced dilation.
Measured: From enrollment to the end of treatment after six month.
The additional effect of an anti-hypertensive treatment plus an individualizes exercise therapy on the arterial stiffness compared to a guideline based anti-hypertensive treatment with general lifestyle recommendations.
Changes in arterial stiffness will be analyzed based on the central pulse wave velocity.
Measured: From enrollment to the end of treatment after six month.
Effect of an guideline based anti-hypertensive therapy on arterial stiffness.
Changes in arterial stiffness will be analyzed based on the central pulse wave velocity.
Measured: From enrollment to the end of treatment after six month.
The additional effect of an anti-hypertensive treatment plus an individualizes exercise therapy on physical fitness compared to a guideline based anti-hypertensive treatment with general lifestyle recommendations.
Changes of physical fitness will be analyzed based on cardiopulmonary exercise tests to evaluate peak oxygen uptake (VO2peak).
Measured: From enrollment to the end of treatment after six month.
Effect of an guideline based anti-hypertensive therapy on physical fitness.
Changes of physical fitness will be analyzed based on cardiopulmonary exercise tests to evaluate peak oxygen uptake (VO2peak).
Measured: From enrollment to the end of treatment after six month.
The additional effect of an anti-hypertensive treatment plus an individualizes exercise therapy on the NO metabolism of stored blood samples compared to a guideline based anti-hypertensive treatment with general lifestyle recommendations.
Changes of the NO metabolism will be analyzed based on nitrite, nitrate, ADMA and SDMA with nuclear magnetic resonance spectroscopy and established ELISA kits based on collected and stored blood samples.
Measured: From enrollment to the end of treatment after six month.
Effect of a guideline based anti-hypertensive therapy on the NO metabolism of stored blood samples.
Changes of the NO metabolism will be analyzed based on nitrite, nitrate, ADMA and SDMA with nuclear magnetic resonance spectroscopy and established ELISA kits based on collected and stored blood samples.
Measured: From enrollment to the end of treatment after six month.
The additional effect of an anti-hypertensive treatment plus an individualizes exercise therapy on the metabolic profile of stored blood samples compared to a guideline based anti-hypertensive treatment with general lifestyle recommendations.
Changes of the metabolic profile of stored blood samples will be analyzed by liquid chromatography and high-resolution tandem mass spectrometry.
Measured: From enrollment to the end of treatment after six month.
Effect of a guideline based anti-hypertensive therapy on the metabolic profile of stored blood samples.
Changes of the metabolic profile of stored blood samples will be analyzed by liquid chromatography and high-resolution tandem mass spectrometry.
Measured: From enrollment to the end of treatment after six month.
The additional effect of an anti-hypertensive treatment plus an individualizes exercise therapy on systemic inflammation markers compared to a guideline based anti-hypertensive treatment with general lifestyle recommendations.
Changes of systemic inflammation markers, such as cytokines, will be analyzed by ELISA and OLINK based on stored blood samples.
Measured: From enrollment to the end of treatment after six month.
Effect of a guideline based anti-hypertensive therapy on systemic inflammation markers of stored blood samples.
Changes of systemic inflammation markers, such as cytokines, will be analyzed by ELISA and OLINK based on stored blood samples.
Measured: From enrollment to the end of treatment after six month.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2025
- Study start1 Apr 2025 (estimated)
- Primary completion31 May 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Heinrich-Heine University, DuesseldorfThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Heinrich-Heine University, Duesseldorf
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06823570
- Sponsor's protocol ID
- 2023-2603
- Acronym
- Antitension
- Status last verified
- Feb 2025
- First submitted
- 3 Feb 2025
- Last updated
- 12 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Upon reasonable request, selected study data will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anti-hypertensive Therapy and Exercise Treatment to Improve Vascular Health in Patients With Hypertension. A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT06823570
- Acronym / sponsor ID
- Antitension / 2023-2603
- Conditions
- Hypertension, Vascular Function, Fitness Testing, Metabolism Changes
- Keywords
- cardiorespiratory fitness, retinal microcirculation, endothelial function, exercise training, lifestyle treatment
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Heinrich-Heine University, DuesseldorfUniversity, hospital or other
- Study start
- 1 Apr 2025 (estimated)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 12 Feb 2025 (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.
This is a prospective, monocentric, randomized controlled trial to investigate the effect of anti-hypertensive treatment and/or individualized exercise training intervention on blood pressure and vascular health. Furthermore the investigators want to decipher mechanisms, which contribute to vascular health by analyzing changes in metabolism and cell function in relation to vascular reaction.
Detailed description
Arterial hypertension is a global health burden that affects the structure and function of large and small blood vessels and induces disease-specific end-organ damage. Exercise therapy is highly recommended in the treatment of arterial hypertension to reduce blood pressure and ameliorate hypertension-induced vascular damage. Previous exercise intervention studies have shown that exercise treatment improves vascular dysfunction independently of changes in blood pressure. Several sensitive vascular biomarkers exist that could optimize risk stratification and therapeutic decisions based on the progression of individual vascular damage in patients with arterial hypertension. However, individualized vascular assessment during anti-hypertensive treatment is not yet part of routine clinical practice. In order to improve clinical decision making from a personalized medicine perspective, it is essential to better understand which vascular biomarkers have the best sensitivity in detecting therapy-induced vascular adaptations and whether anti-hypertensive therapy with or without additional exercise improves vascular health in patients with hypertension. The proposed study will evaluate the effects of guideline-directed anti-hypertensive therapy with or without individualized exercise training intervention in 60 patients with hypertension and no previous medical treatment for one year. Regular outpatient assessments of blood pressure and large and small blood vessels will be performed every two months. Anti-hypertensive therapy will be based on the current guidelines of the European Society of Hypertension. The investigators aim to achieve the target blood pressure after six months of treatment. A further six-month follow-up is planned to assess the long-term effects of anti-hypertensive therapy, with or without additional individualized exercise training intervention, on blood pressure and macro- and microvascular health. In addition, the investigators will investigate the effect of metabolic changes induced by anti-hypertensive treatment or individualized exercise training intervention on vascular health.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Individualized exercise training group | Active comparator | Behavioral: Individualized exercise therapy, Behavioral: Lifestyle recommendationsBeside a guideline based anti-hypertensive therapy, patients in the intervention group will receive an individualized exercise training program 3x/week. Exercise training will be a combination of aerobic and resistance training and is based on each patient's individual fitness level. Regular contact between exercise physiologists and patients, as well as group sessions, will help patients to maintain a regular exercise program. |
| Control group | Other | Behavioral: Lifestyle recommendationsBeside a guideline based anti-hypertensive therapy, patients in the lifestyle recommendation group will receive general recommendations such as salt reduction, higher physical activity levels and stress reduction. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- systolic hypertension grade I-II (BP values >140 mmHg to <180 mmHg) without anti-hypertensive medication treatment
Key exclusion criteria (5 listed)
- no written informed consent
- age <18 years
- isolated diastolic hypertension
- medical contraindications for the exercise treatment (for example orthopedic problems or an abnormal ECG during the cardio respiratory exercise test)
- chronic eye diseases on both eyes (for example macular degeneration or glaucoma) or high intraocular pressure (>20 mmHg)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Individualized exercise therapyPatients in the intervention group will receive an individualized exercise training program 3x/week. | Behavioural | Individualized exercise training group |
| Lifestyle recommendationsThe lifestyle recommendation group will receive general recommendations such as salt reduction, higher physical activity levels and stress reduction. | Behavioural | Control group, Individualized exercise training group |
Primary outcome
The additional effect of an anti-hypertensive treatment plus an individualizes exercise therapy on the retinal vessel diameters compared to a guideline based anti-hypertensive treatment with general lifestyle recommendations.
Time frame: From enrollment to the end of treatment after six month.
The retinal vessel diameters will be analyzed based on the arteriolar-to-venular diameter ratio (AVR).
Effect of an guideline based anti-hypertensive therapy on the retinal vessel diameters.
Time frame: From enrollment to the end of treatment after six month.
Changes of retinal vessel diameters will be analyzed based on the arteriolar-to-venular diameter ratio (AVR).
14 secondary outcomes
The additional effect of an anti-hypertensive treatment plus an individualizes exercise therapy on the systolic and diastolic blood pressure compared to a guideline based anti-hypertensive treatment with general lifestyle recommendations.
Time frame: From enrollment to the end of treatment after six month.
Effect of an guideline based anti-hypertensive therapy on the systolic and diastolic blood pressure.
Time frame: From enrollment to the end of treatment after six month.
The additional effect of an anti-hypertensive treatment plus an individualizes exercise therapy on the microvascular endothelial function compared to a guideline based anti-hypertensive treatment with general lifestyle recommendations.
Time frame: From enrollment to the end of treatment after six month.
Effect of an guideline based anti-hypertensive therapy on the microvascular endothelial function.
Time frame: From enrollment to the end of treatment after six month.
The additional effect of an anti-hypertensive treatment plus an individualizes exercise therapy on the arterial stiffness compared to a guideline based anti-hypertensive treatment with general lifestyle recommendations.
Time frame: From enrollment to the end of treatment after six month.
Effect of an guideline based anti-hypertensive therapy on arterial stiffness.
Time frame: From enrollment to the end of treatment after six month.
The additional effect of an anti-hypertensive treatment plus an individualizes exercise therapy on physical fitness compared to a guideline based anti-hypertensive treatment with general lifestyle recommendations.
Time frame: From enrollment to the end of treatment after six month.
Effect of an guideline based anti-hypertensive therapy on physical fitness.
Time frame: From enrollment to the end of treatment after six month.
The additional effect of an anti-hypertensive treatment plus an individualizes exercise therapy on the NO metabolism of stored blood samples compared to a guideline based anti-hypertensive treatment with general lifestyle recommendations.
Time frame: From enrollment to the end of treatment after six month.
Effect of a guideline based anti-hypertensive therapy on the NO metabolism of stored blood samples.
Time frame: From enrollment to the end of treatment after six month.
The additional effect of an anti-hypertensive treatment plus an individualizes exercise therapy on the metabolic profile of stored blood samples compared to a guideline based anti-hypertensive treatment with general lifestyle recommendations.
Time frame: From enrollment to the end of treatment after six month.
Effect of a guideline based anti-hypertensive therapy on the metabolic profile of stored blood samples.
Time frame: From enrollment to the end of treatment after six month.
The additional effect of an anti-hypertensive treatment plus an individualizes exercise therapy on systemic inflammation markers compared to a guideline based anti-hypertensive treatment with general lifestyle recommendations.
Time frame: From enrollment to the end of treatment after six month.
Effect of a guideline based anti-hypertensive therapy on systemic inflammation markers of stored blood samples.
Time frame: From enrollment to the end of treatment after six month.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2025.
- Individual participant dataSharing planned: Yes. Upon reasonable request, selected study data will be shared.
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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.
Johannes Stegbauer, Prof. Dr. contact
Lukas Streese, PhD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Individualized exercise therapy and Lifestyle recommendations in people with Hypertension and Vascular Function, run by Heinrich-Heine University, Duesseldorf 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 1 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 12 Mar 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Johannes Stegbauer, Prof. Dr. (+49 211 81 080 74, Studienzentrum-Nephrologie@med.uni-duesseldorf.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The additional effect of an anti-hypertensive treatment plus an individualizes exercise therapy on the retinal vessel diameters compared to a guideline based anti-hypertensive treatment with general lifestyle recommendations. (time frame: From enrollment to the end of treatment after six month.). The study lists 2 primary outcomes in all. 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 12 Mar 2025.