HypertensionHyperVascNCT04763005
Hypertension and Retinal Microvascular Dysfunction
A study testing HIIT exercise intervention and Physical activity recommendations in people with Hypertension, run by University of Basel at 1 site in Switzerland.
Trial summary
Hypertension is a worldwide health care burden that affects the structure and function of the macro- and microcirculation. Non-invasive vascular biomarkers are essential to timely diagnose end organ damage to improve cardiovascular (CV) risk stratification and medical decision making. Read more about this study
- Who is it for?
- Ages 40 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertension
- What is being tested?
- HIIT exercise intervention and Physical activity recommendations
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 1 siteSwitzerland
- Study dates
- 12 Feb 2021to 20 May 2022
- Phase
- Interventional
- 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 40 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men and Women between 40 and 70 years of age
- hypertension (≥90 mmHg diastolic or ≥140 mmHg systolic BP during 24h monitoring or hypertensive medication) or normal blood pressure (≤85 mmHg diastolic and ≤130 mmHg systolic BP during 24h monitoring and no hypertensive medication).
Who cannot join
- Any cardiovascular (CV) medication (accept for hypertensive medication in the hypertensive group)
- history of CV, pulmonary, or chronic inflammatory disease
- active smoking status
- any chronic eye disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Hypertension and Retinal Microvascular Dysfunction: A Cross-sectional and Randomized Controlled Exercise Trial
Hypertension is a worldwide health care burden that affects the structure and function of the macro- and microcirculation. Non-invasive vascular biomarkers are essential to timely diagnose end organ damage to improve cardiovascular (CV) risk stratification and medical decision making. The "Hypertension and retinal microvascular dysfunction" (HyperVasc) trial will investigate macro- and microvascular impairments in hypertensive patients and healthy controls to investigate hypertension-induced end organ damage by using gold-standard methods as well as newly developed and unique retinal microvascular biomarkers. Additionally, this trial will investigate the reversible effects of an eight weeks supervised and walking based high-intensity exercise intervention on blood pressure as well as macro- and microvascular health, compared to a control group with standard physical activity recommendations. Secondary outcomes will be cardiorespiratory fitness, physical activity, microalbuminuria, hypertensive retinopathy, and classical cardiovascular risk marker. The results of the HyperVasc trial will improve the understanding of hypertension-induced vascular impairments and will push the development of non-invasive vascular biomarker to screen end organ damage in general CV risk stratification.
- Conditions
- Hypertension
- Being tested
- HIIT exercise intervention, Physical activity recommendations
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HIIT exercise interventionBehavioural
The exercise intervention will be eight weeks of high-intensity interval training (HIIT) started by one warm-up week with an intensity of 75% maximum heart rate (HRmax). In the following seven weeks, the participants will perform a HIIT based on the following protocol and with a total duration of 45 minutes per session: warm-up for 10 minutes at 60-70% HRmax followed by a high-intensity interval consisting of 4x4 minutes at 80-90% HRmax with 3 minutes of active recovery at 60-70% HRmax and a 10 minutes cool-down at 60-70% HRmax. HR will be monitored during training by Polar® H7 heart rate sensors combined with Polar® M400 watches.
Physical activity recommendationsBehavioural
The control group will get physical activity recommendations based on actual guidelines from the European Association of Preventive Cardiology.
| Study group | Role | What they receive |
|---|---|---|
| Healthy controls | No intervention | A cross-sectional investigation of 24h blood pressure, macro- and microvascular health, physical activity and fitness as well as anthropometry. |
| Hypertensive Patients | Experimental | A cross-sectional investigation of 24h blood pressure, macro- and microvascular health, physical activity and fitness as well as anthropometry. In addition, randomization to an eight-week high-intensity interval intervention or control condition with physical activity recommendations. Receives: Behavioral: HIIT exercise intervention; Behavioral: Physical activity recommendations |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline arteriolar-to-venular diameter ratio to 8 weeks post-intervention
Measured: Baseline and 8 weeks post-intervention
Arteriolar-to-venular diameter ratio differences between healthy controls and hypertensive patients
Measured: Baseline
Secondary outcomes (10)
Change from baseline central retinal arteriolar and venular diameter equivalents to 8 weeks post-intervention
mu
Measured: Baseline and 8 weeks post-intervention
Central retinal arteriolar and venular diameter equivalent differences between healthy controls and hypertensive patients
mu
Measured: Baseline
Change from baseline arteriolar and venular flicker-light induced dilatation response to 8 weeks post-intervention
Measured: Baseline and 8 weeks post-intervention
arteriolar and venular flicker-light induced dilatation response differences between healthy controls and hypertensive patients
Measured: Baseline
Change from baseline pulse wave velocity to 8 weeks post-intervention
m/s
Measured: Baseline and 8 weeks post-intervention
Pulse wave velocity differences between healthy controls and hypertensive patients
m/s
Measured: Baseline
Change from baseline 24h blood pressure to 8 weeks post-intervention
mmHg
Measured: Baseline and 8 weeks post-intervention
24h blood pressure differences between healthy controls and hypertensive patients
mmHg
Measured: Baseline
Change from baseline cardiorespiratory fitness to 8 weeks post-intervention
VO2peak (ml/min/kg)
Measured: Baseline and 8 weeks post-intervention
Cardiorespiratory fitness differences between healthy controls and hypertensive patients
VO2peak (ml/min/kg)
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2021
- Study start12 Feb 2021
- Primary completion1 May 2022
- Study completion20 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Basel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Henner Hanssen, University of Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04763005
- Sponsor's protocol ID
- HyperVasc
- Acronym
- HyperVasc
- Status last verified
- Jun 2022
- First submitted
- 12 Feb 2021
- Last updated
- 3 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Schwendinger F, Wagner J, Hauser C, Fleischlin E, Carrard J, Schmidt-Trucksass A, Hanssen H, Streese L. All eyes on gas exchange: impact of controlled arterial hypertension on cardiopulmonary function and the effects of high-intensity interval training. J Hypertens. 2026 Oct 1;44(10):1881-1889. doi: 10.1097/HJH.0000000000004394. Epub 2026 Jul 16.
PubMed 42488976Streese L, Gander J, Carrard J, Hauser C, Hinrichs T, Schmidt-Trucksass A, Gugleta K, Hanssen H. Hypertension and retinal microvascular dysfunction (HyperVasc): protocol of a randomised controlled exercise trial in patients with hypertension. BMJ Open. 2022 Jun 6;12(6):e058997. doi: 10.1136/bmjopen-2021-058997.
PubMed 35667713
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypertension and Retinal Microvascular Dysfunction: A Cross-sectional and Randomized Controlled Exercise Trial
- ClinicalTrials.gov ID
- NCT04763005
- Acronym / sponsor ID
- HyperVasc / HyperVasc
- Conditions
- Hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- University of BaselUniversity, hospital or other
- Study start
- 12 Feb 2021 (actual)
- Primary completion
- 1 May 2022 (actual)
- Study completion
- 20 May 2022 (actual)
- First posted
- 21 Feb 2021 (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.
Hypertension is a worldwide health care burden that affects the structure and function of the macro- and microcirculation. Non-invasive vascular biomarkers are essential to timely diagnose end organ damage to improve cardiovascular (CV) risk stratification and medical decision making. The "Hypertension and retinal microvascular dysfunction" (HyperVasc) trial will investigate macro- and microvascular impairments in hypertensive patients and healthy controls to investigate hypertension-induced end organ damage by using gold-standard methods as well as newly developed and unique retinal microvascular biomarkers. Additionally, this trial will investigate the reversible effects of an eight weeks supervised and walking based high-intensity exercise intervention on blood pressure as well as macro- and microvascular health, compared to a control group with standard physical activity recommendations. Secondary outcomes will be cardiorespiratory fitness, physical activity, microalbuminuria, hypertensive retinopathy, and classical cardiovascular risk marker. The results of the HyperVasc trial will improve the understanding of hypertension-induced vascular impairments and will push the development of non-invasive vascular biomarker to screen end organ damage in general CV risk stratification.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy controls | No intervention | –A cross-sectional investigation of 24h blood pressure, macro- and microvascular health, physical activity and fitness as well as anthropometry. |
| Hypertensive Patients | Experimental | Behavioral: HIIT exercise intervention, Behavioral: Physical activity recommendationsA cross-sectional investigation of 24h blood pressure, macro- and microvascular health, physical activity and fitness as well as anthropometry. In addition, randomization to an eight-week high-intensity interval intervention or control condition with physical activity recommendations. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Men and Women between 40 and 70 years of age
- hypertension (≥90 mmHg diastolic or ≥140 mmHg systolic BP during 24h monitoring or hypertensive medication) or normal blood pressure (≤85 mmHg diastolic and ≤130 mmHg systolic BP during 24h monitoring and no hypertensive medication).
Key exclusion criteria (4 listed)
- Any cardiovascular (CV) medication (accept for hypertensive medication in the hypertensive group)
- history of CV, pulmonary, or chronic inflammatory disease
- active smoking status
- any chronic eye disease.
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 |
|---|---|---|
| HIIT exercise interventionThe exercise intervention will be eight weeks of high-intensity interval training (HIIT) started by one warm-up week with an intensity of 75% maximum heart rate (HRmax). In the following seven weeks, the participants will perform a HIIT based on the following protocol and with a total duration of 45 minutes per session: warm-up for 10 minutes at 60-70% HRmax followed by a high-intensity interval consisting of 4x4 minutes at 80-90% HRmax with 3 minutes of active recovery at 60-70% HRmax and a 10 minutes cool-down at 60-70% HRmax. HR will be monitored during training by Polar® H7 heart rate sensors combined with Polar® M400 watches. | Behavioural | Hypertensive Patients |
| Physical activity recommendationsThe control group will get physical activity recommendations based on actual guidelines from the European Association of Preventive Cardiology. | Behavioural | Hypertensive Patients |
Primary outcome
Change from baseline arteriolar-to-venular diameter ratio to 8 weeks post-intervention
Time frame: Baseline and 8 weeks post-intervention
Arteriolar-to-venular diameter ratio differences between healthy controls and hypertensive patients
Time frame: Baseline
10 secondary outcomes
Change from baseline central retinal arteriolar and venular diameter equivalents to 8 weeks post-intervention
Time frame: Baseline and 8 weeks post-intervention
Central retinal arteriolar and venular diameter equivalent differences between healthy controls and hypertensive patients
Time frame: Baseline
Change from baseline arteriolar and venular flicker-light induced dilatation response to 8 weeks post-intervention
Time frame: Baseline and 8 weeks post-intervention
arteriolar and venular flicker-light induced dilatation response differences between healthy controls and hypertensive patients
Time frame: Baseline
Change from baseline pulse wave velocity to 8 weeks post-intervention
Time frame: Baseline and 8 weeks post-intervention
Pulse wave velocity differences between healthy controls and hypertensive patients
Time frame: Baseline
Change from baseline 24h blood pressure to 8 weeks post-intervention
Time frame: Baseline and 8 weeks post-intervention
24h blood pressure differences between healthy controls and hypertensive patients
Time frame: Baseline
Change from baseline cardiorespiratory fitness to 8 weeks post-intervention
Time frame: Baseline and 8 weeks post-intervention
Cardiorespiratory fitness differences between healthy controls and hypertensive patients
Time frame: Baseline
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 3 Jun 2022.
- Derived from this study: PubMed 42488976Schwendinger F, Wagner J, Hauser C, Fleischlin E, Carrard J, Schmidt-Trucksass A, Hanssen H, Streese L. All eyes on gas exchange: impact of controlled arterial hypertension on cardiopulmonary function and the effects of high-intensity interval training. J Hypertens. 2026 Oct 1;44(10):1881-1889. doi: 10.1097/HJH.0000000000004394. Epub 2026 Jul 16.
- Derived from this study: PubMed 35667713Streese L, Gander J, Carrard J, Hauser C, Hinrichs T, Schmidt-Trucksass A, Gugleta K, Hanssen H. Hypertension and retinal microvascular dysfunction (HyperVasc): protocol of a randomised controlled exercise trial in patients with hypertension. BMJ Open. 2022 Jun 6;12(6):e058997. doi: 10.1136/bmjopen-2021-058997.
- Individual participant dataSharing planned: Undecided
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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. 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?
A study testing HIIT exercise intervention and Physical activity recommendations in people with Hypertension, run by University of Basel at 1 site in Switzerland.
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 2 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 3 Jun 2022. 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 Switzerland. 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?
Change from baseline arteriolar-to-venular diameter ratio to 8 weeks post-intervention (time frame: Baseline and 8 weeks post-intervention). 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?
On the ClinicalTrials.gov record for NCT04763005, which also lists 2 linked publications.
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 3 Jun 2022.