Hypertension and Retinal Microvascular Dysfunction (HyperVasc)

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.

Study Overview

• Status: Completed
• Conditions: Hypertension
• Intervention / Treatment: Behavioral: HIIT exercise intervention; Behavioral: Physical activity recommendations

• Study Type: Interventional
• Enrollment (Actual): 85
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Basel, Switzerland, 4052
    • Department of Sports, Exercise and Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Healthy controls; A cross-sectional investigation of 24h blood pressure, macro- and microvascular health, physical activity and fitness as well as anthropometry.
Experimental: Hypertensive Patients; 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.	Behavioral: HIIT exercise intervention; 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.; Behavioral: Physical activity recommendations; The control group will get physical activity recommendations based on actual guidelines from the European Association of Preventive Cardiology.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

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

Collaborators and Investigators

• Sponsor: University of Basel

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 12, 2021
• Primary Completion (Actual): May 1, 2022
• Study Completion (Actual): May 20, 2022

Study Registration Dates

• First Submitted: February 12, 2021
• First Submitted That Met QC Criteria: February 17, 2021
• First Posted (Actual): February 21, 2021

Study Record Updates

• Last Update Posted (Actual): June 3, 2022
• Last Update Submitted That Met QC Criteria: June 2, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: HyperVasc

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No