Hypertension and Retinal Microvascular Dysfunction

NCT04763005 | Completed

• 1 other identifier: HyperVasc
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (10)

• Change from baseline central retinal arteriolar and venular diameter equivalents to 8 weeks post-intervention

  Baseline and 8 weeks post-intervention

• Central retinal arteriolar and venular diameter equivalent differences between healthy controls and hypertensive patients

  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

  Baseline and 8 weeks post-intervention

Study Arms (2)

Healthy controls

NO INTERVENTION

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

Hypertensive Patients

EXPERIMENTAL

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; Behavioral: Physical activity recommendations

Interventions

HIIT exercise intervention 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.

Hypertensive Patients

Physical activity recommendations BEHAVIORAL

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

Hypertensive Patients

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Basel: lead

Study Sites (1)

Department of Sports, Exercise and Health

Basel, 4052, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 35667713 DERIVED

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: February 12, 2021
• First Posted: February 21, 2021
• Study Start: February 12, 2021
• Primary Completion: May 1, 2022
• Study Completion: May 20, 2022
• Last Updated: June 3, 2022

Record last verified: 2022-06

Locations

CH (1)