Hypertension and Retinal Microvascular Dysfunction

NCT ID: NCT04763005

Last Updated: 2022-06-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 85 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-12
• Study Completion Date: 2022-05-20

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.

Conditions

Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Healthy controls

A cross-sectional investigation of 24h blood pressure, macro- and microvascular health, physical activity and fitness as well as anthropometry.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

HIIT exercise intervention

Intervention Type: BEHAVIORAL

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

Intervention Type: BEHAVIORAL

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

Interventions

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.

Intervention Type: BEHAVIORAL

Physical activity recommendations

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

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Basel

OTHER

Sponsor Role: lead

Responsible Party

Henner Hanssen

Prof. Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Department of Sports, Exercise and Health

Basel, , Switzerland

Countries

Switzerland

References

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.

Reference Type: DERIVED

PMID: 35667713 (View on PubMed)

Other Identifiers

HyperVasc

Identifier Type: -

Identifier Source: org_study_id