Clinical trial NCT04763005: Hypertension and Retinal Microvascular Dysfunction
Official title: Hypertension and Retinal Microvascular Dysfunction: A Cross-sectional and Randomized Controlled Exercise Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Lead sponsor: University of Basel
Sponsor class: OTHER
First posted: 2021-02-21
Enrollment: 85
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* 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).

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Change from baseline arteriolar-to-venular diameter ratio to 8 weeks post-intervention
timeFrame: Baseline and 8 weeks post-intervention
measure: Arteriolar-to-venular diameter ratio differences between healthy controls and hypertensive patients
timeFrame: Baseline
Secondary outcomes:
measure: Change from baseline central retinal arteriolar and venular diameter equivalents to 8 weeks post-intervention
timeFrame: Baseline and 8 weeks post-intervention
measure: Central retinal arteriolar and venular diameter equivalent differences between healthy controls and hypertensive patients
timeFrame: Baseline
measure: Change from baseline arteriolar and venular flicker-light induced dilatation response to 8 weeks post-intervention
timeFrame: Baseline and 8 weeks post-intervention
measure: arteriolar and venular flicker-light induced dilatation response differences between healthy controls and hypertensive patients
timeFrame: Baseline
measure: Change from baseline pulse wave velocity to 8 weeks post-intervention
timeFrame: Baseline and 8 weeks post-intervention
measure: Pulse wave velocity differences between healthy controls and hypertensive patients
timeFrame: Baseline
measure: Change from baseline 24h blood pressure to 8 weeks post-intervention
timeFrame: Baseline and 8 weeks post-intervention
measure: 24h blood pressure differences between healthy controls and hypertensive patients
timeFrame: Baseline
measure: Change from baseline cardiorespiratory fitness to 8 weeks post-intervention
timeFrame: Baseline and 8 weeks post-intervention
measure: Cardiorespiratory fitness differences between healthy controls and hypertensive patients
timeFrame: Baseline
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Department of Sports, Exercise and Health
Study officials:
References:
citation: Streese 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.