Hypertension and Retinal Microvascular Dysfunction

Not Applicable

Completed

• Conditions: Hypertension
• Interventions: Behavioral: HIIT exercise intervention; Behavioral: Physical activity recommendations

• Registration Number: NCT04763005
• Lead Sponsor: University of Basel

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-02-12
• Study First Submitted: 2021-02-12
• Study First Submitted QC: 2021-02-17
• Study First Posted: 2021-02-21
• Primary Completion: 2022-05-01
• Study Completion: 2022-05-20
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-02
• Last Update Posted: 2022-06-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 85

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hypertensive Patients	Physical activity recommendations	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.
Hypertensive Patients	HIIT exercise intervention	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.

Primary Outcome Measures

Name	Time	Method
Change from baseline arteriolar-to-venular diameter ratio to 8 weeks post-intervention	Baseline and 8 weeks post-intervention
Arteriolar-to-venular diameter ratio differences between healthy controls and hypertensive patients	Baseline

Secondary Outcome Measures

Name	Time	Method
Central retinal arteriolar and venular diameter equivalent differences between healthy controls and hypertensive patients	Baseline	mu
arteriolar and venular flicker-light induced dilatation response differences between healthy controls and hypertensive patients	Baseline
Pulse wave velocity differences between healthy controls and hypertensive patients	Baseline	m/s
Change from baseline arteriolar and venular flicker-light induced dilatation response to 8 weeks post-intervention	Baseline and 8 weeks post-intervention
Change from baseline 24h blood pressure to 8 weeks post-intervention	Baseline and 8 weeks post-intervention	mmHg
Change from baseline central retinal arteriolar and venular diameter equivalents to 8 weeks post-intervention	Baseline and 8 weeks post-intervention	mu
Change from baseline pulse wave velocity to 8 weeks post-intervention	Baseline and 8 weeks post-intervention	m/s
24h blood pressure differences between healthy controls and hypertensive patients	Baseline	mmHg
Change from baseline cardiorespiratory fitness to 8 weeks post-intervention	Baseline and 8 weeks post-intervention	VO2peak (ml/min/kg)
Cardiorespiratory fitness differences between healthy controls and hypertensive patients	Baseline	VO2peak (ml/min/kg)

Trial Locations

Locations (1)

Department of Sports, Exercise and Health; 🇨🇭 Basel, Switzerland