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Completed

NCT Number: NCT04763005

Hypertension and Retinal Microvascular Dysfunction

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.

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

40 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Sports, Exercise and Health

Basel, 4052, Switzerland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Physical activity recommendations

Behavioral

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

Primary outcomes

  1. Change from baseline arteriolar-to-venular diameter ratio to 8 weeks post-intervention

    Time frame: Baseline and 8 weeks post-intervention

  2. Arteriolar-to-venular diameter ratio differences between healthy controls and hypertensive patients

    Time frame: Baseline

Secondary outcomes

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

    Time frame: Baseline and 8 weeks post-intervention

    mu

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

    Time frame: Baseline

    mu

  3. Change from baseline arteriolar and venular flicker-light induced dilatation response to 8 weeks post-intervention

    Time frame: Baseline and 8 weeks post-intervention

  4. arteriolar and venular flicker-light induced dilatation response differences between healthy controls and hypertensive patients

    Time frame: Baseline

  5. Change from baseline pulse wave velocity to 8 weeks post-intervention

    Time frame: Baseline and 8 weeks post-intervention

    m/s

  6. Pulse wave velocity differences between healthy controls and hypertensive patients

    Time frame: Baseline

    m/s

  7. Change from baseline 24h blood pressure to 8 weeks post-intervention

    Time frame: Baseline and 8 weeks post-intervention

    mmHg

  8. 24h blood pressure differences between healthy controls and hypertensive patients

    Time frame: Baseline

    mmHg

  9. Change from baseline cardiorespiratory fitness to 8 weeks post-intervention

    Time frame: Baseline and 8 weeks post-intervention

    VO2peak (ml/min/kg)

  10. Cardiorespiratory fitness differences between healthy controls and hypertensive patients

    Time frame: Baseline

    VO2peak (ml/min/kg)

Sponsors and collaborators

Lead sponsor

University of Basel

Other

Registry information

Official study title

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

Acronym: HyperVasc

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Feb 21, 2021
Registry last updated
Jun 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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