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Impact of Aerobic Exercise Training on Sympathetic Vasoconstriction and Vascular Function in Essential Hypertension (IMPROVEH)

Primary Purpose

Hypertension,Essential

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Training
Sponsored by
University of Copenhagen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Hypertension,Essential focused on measuring Pannexin-1 channel

Eligibility Criteria

35 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Sedentary men and women age 35 - 65 years
  • Resting blood pressure >140/90 mmHg or Resting blood pressure <140/90 mmHg
  • Essential hypertension
  • Non or exclusively antihypertensive medication

Exclusion Criteria:

  • Hypertensive condition other than essential hypertension
  • Other chronical diseases
  • Smoking
  • Excess alcohol intake or drug abuse

Sites / Locations

  • University of Copenhagen

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Hypertensive

Control

Arm Description

Men and women in age-group 35-65 years Resting blood pressure of >140/90 mmHg non or only anti-hypertensive medication

Men and women in age-group 35-65 years Resting blood pressure of <140/90 mmHg no medication

Outcomes

Primary Outcome Measures

Blood pressure
Changes in systolic and diastolic blood pressure

Secondary Outcome Measures

Pannexin channel function assessed in vivo
Pannexin channel function is assessed by measurement of vascular conductance with and without channel inhibition
Pannexin channel distribution in skeletal muscle tissue
Pannexin channel distribution is assessed immunohistochemically in muscle samples
Sympathetic activity
Direct measurement of Muscle Sympathetic Nervous Activity via microneurography
Vascular function
Vascular conductance measured by ultrasound doppler during infusion of vasoactive substances
Mitochondrial function in endothelial cells
Endothelial cell mitochondrial respiration is measured by High Resolution Respirometry
Reactive oxygen species formation in in endothelial cells
Endothelial cell production of reactive oxygen species is measured by High Resolution Respirometry
Rheology
Platelet rheology. The viscoelastic measurements are based on attainment of the Gel Point (GP) from which the fractal dimension, df, is determined.
Platelet reactivity
Platelet reactivity is assessed by multiplate aggregometry
Maximal oxygen uptake
Direct Measurement of oxygen uptake during a graded test on cycle ergometer
Body Composition
Measured by Dual energy x-ray absorptiometry
Endothelial cell characterization
Assessment of protein and mRNA-levels of proteins of relevance for endothelial function
Skeletal muscle characterization
Assessment of protein and mRNA-levels of proteins of relevance for skeletal muscle function

Full Information

First Posted
December 6, 2018
Last Updated
November 1, 2022
Sponsor
University of Copenhagen
Collaborators
Lundbeck Foundation, Danish Council for Independent Research
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1. Study Identification

Unique Protocol Identification Number
NCT03778489
Brief Title
Impact of Aerobic Exercise Training on Sympathetic Vasoconstriction and Vascular Function in Essential Hypertension
Acronym
IMPROVEH
Official Title
Impact of Aerobic Exercise Training on Sympathetically Mediated Vasoconstriction and Vascular Function in Individuals With Essential Hypertension (IMPROVEH)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
February 19, 2019 (Actual)
Primary Completion Date
November 1, 2022 (Actual)
Study Completion Date
November 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Copenhagen
Collaborators
Lundbeck Foundation, Danish Council for Independent Research

4. Oversight

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

5. Study Description

Brief Summary
Sympathetic nervous activity plays an important role in the development of hypertension and studies have shown that the pannexin-1 channel is involved in the signalling of the sympathetic activity to the vascular bed. The main project aim is to investigate the effects of 10 weeks of high intensity training on the effect of the sympathetic nervous activity on vascular function in individuals with essential hypertension. A secondary aim is to assess the role of essential hypertension and physical activity on vascular endothelial function,

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension,Essential
Keywords
Pannexin-1 channel

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized double blinded case-control interventional study
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hypertensive
Arm Type
Experimental
Arm Description
Men and women in age-group 35-65 years Resting blood pressure of >140/90 mmHg non or only anti-hypertensive medication
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Men and women in age-group 35-65 years Resting blood pressure of <140/90 mmHg no medication
Intervention Type
Other
Intervention Name(s)
Training
Intervention Description
10 weeks of high intensity exercise training. 2-3 trainings per week of approx. 40 min.
Primary Outcome Measure Information:
Title
Blood pressure
Description
Changes in systolic and diastolic blood pressure
Time Frame
Before and after 8 weeks of training
Secondary Outcome Measure Information:
Title
Pannexin channel function assessed in vivo
Description
Pannexin channel function is assessed by measurement of vascular conductance with and without channel inhibition
Time Frame
Before and after 8 weeks of training
Title
Pannexin channel distribution in skeletal muscle tissue
Description
Pannexin channel distribution is assessed immunohistochemically in muscle samples
Time Frame
Before and after 8 weeks of training
Title
Sympathetic activity
Description
Direct measurement of Muscle Sympathetic Nervous Activity via microneurography
Time Frame
Before and after 8 weeks of training
Title
Vascular function
Description
Vascular conductance measured by ultrasound doppler during infusion of vasoactive substances
Time Frame
Before and after 8 weeks of training
Title
Mitochondrial function in endothelial cells
Description
Endothelial cell mitochondrial respiration is measured by High Resolution Respirometry
Time Frame
Before and after 8 weeks of training
Title
Reactive oxygen species formation in in endothelial cells
Description
Endothelial cell production of reactive oxygen species is measured by High Resolution Respirometry
Time Frame
Before and after 8 weeks of training
Title
Rheology
Description
Platelet rheology. The viscoelastic measurements are based on attainment of the Gel Point (GP) from which the fractal dimension, df, is determined.
Time Frame
Before and after 8 weeks of training
Title
Platelet reactivity
Description
Platelet reactivity is assessed by multiplate aggregometry
Time Frame
Before and after 8 weeks of training
Title
Maximal oxygen uptake
Description
Direct Measurement of oxygen uptake during a graded test on cycle ergometer
Time Frame
Before and after 8 weeks of training
Title
Body Composition
Description
Measured by Dual energy x-ray absorptiometry
Time Frame
Before and after 8 weeks of training
Title
Endothelial cell characterization
Description
Assessment of protein and mRNA-levels of proteins of relevance for endothelial function
Time Frame
Before and after 8 weeks of training
Title
Skeletal muscle characterization
Description
Assessment of protein and mRNA-levels of proteins of relevance for skeletal muscle function
Time Frame
Before and after 8 weeks of training

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Sedentary men and women age 35 - 65 years Resting blood pressure >140/90 mmHg or Resting blood pressure <140/90 mmHg Essential hypertension Non or exclusively antihypertensive medication Exclusion Criteria: Hypertensive condition other than essential hypertension Other chronical diseases Smoking Excess alcohol intake or drug abuse
Facility Information:
Facility Name
University of Copenhagen
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
Currently awaiting instructions on this issue from the department
Citations:
PubMed Identifier
35420578
Citation
Moller S, Hansen CC, Ehlers TS, Tamariz-Ellemann A, Tolborg SAR, Kurell ME, Perez-Gomez J, Patrzalek SS, Maulitz C, Hellsten Y, Gliemann L. Exercise Training Lowers Arterial Blood Pressure Independently of Pannexin 1 in Men with Essential Hypertension. Med Sci Sports Exerc. 2022 Sep 1;54(9):1417-1427. doi: 10.1249/MSS.0000000000002936. Epub 2022 Apr 12.
Results Reference
derived

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Impact of Aerobic Exercise Training on Sympathetic Vasoconstriction and Vascular Function in Essential Hypertension

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