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Hypertension and Retinal Microvascular Dysfunction (HyperVasc)

Primary Purpose

Hypertension

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
HIIT exercise intervention
Physical activity recommendations
Sponsored by
University of Basel
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Department of Sports, Exercise and Health

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Healthy controls

Hypertensive Patients

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Change from baseline arteriolar-to-venular diameter ratio to 8 weeks post-intervention
Arteriolar-to-venular diameter ratio differences between healthy controls and hypertensive patients

Secondary Outcome Measures

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

Full Information

First Posted
February 12, 2021
Last Updated
June 2, 2022
Sponsor
University of Basel
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1. Study Identification

Unique Protocol Identification Number
NCT04763005
Brief Title
Hypertension and Retinal Microvascular Dysfunction
Acronym
HyperVasc
Official Title
Hypertension and Retinal Microvascular Dysfunction: A Cross-sectional and Randomized Controlled Exercise Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
February 12, 2021 (Actual)
Primary Completion Date
May 1, 2022 (Actual)
Study Completion Date
May 20, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Basel

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
85 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Healthy controls
Arm Type
No Intervention
Arm Description
A cross-sectional investigation of 24h blood pressure, macro- and microvascular health, physical activity and fitness as well as anthropometry.
Arm Title
Hypertensive Patients
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
HIIT exercise intervention
Intervention Description
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
Intervention Name(s)
Physical activity recommendations
Intervention Description
The control group will get physical activity recommendations based on actual guidelines from the European Association of Preventive Cardiology.
Primary Outcome Measure Information:
Title
Change from baseline arteriolar-to-venular diameter ratio to 8 weeks post-intervention
Time Frame
Baseline and 8 weeks post-intervention
Title
Arteriolar-to-venular diameter ratio differences between healthy controls and hypertensive patients
Time Frame
Baseline
Secondary Outcome Measure Information:
Title
Change from baseline central retinal arteriolar and venular diameter equivalents to 8 weeks post-intervention
Description
mu
Time Frame
Baseline and 8 weeks post-intervention
Title
Central retinal arteriolar and venular diameter equivalent differences between healthy controls and hypertensive patients
Description
mu
Time Frame
Baseline
Title
Change from baseline arteriolar and venular flicker-light induced dilatation response to 8 weeks post-intervention
Time Frame
Baseline and 8 weeks post-intervention
Title
arteriolar and venular flicker-light induced dilatation response differences between healthy controls and hypertensive patients
Time Frame
Baseline
Title
Change from baseline pulse wave velocity to 8 weeks post-intervention
Description
m/s
Time Frame
Baseline and 8 weeks post-intervention
Title
Pulse wave velocity differences between healthy controls and hypertensive patients
Description
m/s
Time Frame
Baseline
Title
Change from baseline 24h blood pressure to 8 weeks post-intervention
Description
mmHg
Time Frame
Baseline and 8 weeks post-intervention
Title
24h blood pressure differences between healthy controls and hypertensive patients
Description
mmHg
Time Frame
Baseline
Title
Change from baseline cardiorespiratory fitness to 8 weeks post-intervention
Description
VO2peak (ml/min/kg)
Time Frame
Baseline and 8 weeks post-intervention
Title
Cardiorespiratory fitness differences between healthy controls and hypertensive patients
Description
VO2peak (ml/min/kg)
Time Frame
Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Facility Information:
Facility Name
Department of Sports, Exercise and Health
City
Basel
ZIP/Postal Code
4052
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
35667713
Citation
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.
Results Reference
derived

Learn more about this trial

Hypertension and Retinal Microvascular Dysfunction

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