Hypertension and Retinal Microvascular Dysfunction

Hypertension Clinical Trial

— HyperVasc  

Official title:

Hypertension and Retinal Microvascular Dysfunction: A Cross-sectional and Randomized Controlled Exercise Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04763005
• Other study ID #: HyperVasc
• Status: Completed
• Phase: N/A
• Start date: February 12, 2021
• Est. completion date: May 20, 2022

Study information

• Verified date: June 2022
• Source: University of Basel
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 85
• Est. completion date: May 20, 2022
• Est. primary completion date: May 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hypertension

Intervention

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.
• Physical activity recommendations
The control group will get physical activity recommendations based on actual guidelines from the European Association of Preventive Cardiology.

Locations

Country	Name	City	State
Switzerland	Department of Sports, Exercise and Health	Basel

Sponsors (1)

Lead Sponsor	Collaborator
University of Basel

Country where clinical trial is conducted

Switzerland, 

Outcome

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