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

• Sponsor: University of Copenhagen (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT03778489
• Collaborator: Lundbeck Foundation (Other), Danish Council for Independent Research (Other)
• Enrollment: 30
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 46.4
• Patients Per Site Per Month: 0.6

Study Details

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,

Condition or Disease	Intervention/Treatment	Phase
Hypertension,Essential	Other: Training	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Randomized double blinded case-control interventional studyRandomized double blinded case-control interventional study
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Basic Science
• Official Title: Impact of Aerobic Exercise Training on Sympathetically Mediated Vasoconstriction and Vascular Function in Individuals With Essential Hypertension (IMPROVEH)
• Actual Study Start Date: Feb 19, 2019
• Anticipated Primary Completion Date: Oct 31, 2022
• Anticipated Study Completion Date: Dec 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Hypertensive Men and women in age-group 35-65 years Resting blood pressure of >140/90 mmHg non or only anti-hypertensive medication	Other: Training; 10 weeks of high intensity exercise training. 2-3 trainings per week of approx. 40 min.
Active Comparator: Control Men and women in age-group 35-65 years Resting blood pressure of <140/90 mmHg no medication	Other: Training; 10 weeks of high intensity exercise training. 2-3 trainings per week of approx. 40 min.

Outcome Measures

Primary Outcome Measures

1. Blood pressure [Before and after 8 weeks of training]

   Changes in systolic and diastolic blood pressure

Secondary Outcome Measures

1. Pannexin channel function assessed in vivo [Before and after 8 weeks of training]

   Pannexin channel function is assessed by measurement of vascular conductance with and without channel inhibition

2. Pannexin channel distribution in skeletal muscle tissue [Before and after 8 weeks of training]

   Pannexin channel distribution is assessed immunohistochemically in muscle samples

3. Sympathetic activity [Before and after 8 weeks of training]

   Direct measurement of Muscle Sympathetic Nervous Activity via microneurography

4. Vascular function [Before and after 8 weeks of training]

   Vascular conductance measured by ultrasound doppler during infusion of vasoactive substances

5. Mitochondrial function in endothelial cells [Before and after 8 weeks of training]

   Endothelial cell mitochondrial respiration is measured by High Resolution Respirometry

6. Reactive oxygen species formation in in endothelial cells [Before and after 8 weeks of training]

   Endothelial cell production of reactive oxygen species is measured by High Resolution Respirometry

7. Rheology [Before and after 8 weeks of training]

   Platelet rheology. The viscoelastic measurements are based on attainment of the Gel Point (GP) from which the fractal dimension, df, is determined.

8. Platelet reactivity [Before and after 8 weeks of training]

   Platelet reactivity is assessed by multiplate aggregometry

9. Maximal oxygen uptake [Before and after 8 weeks of training]

   Direct Measurement of oxygen uptake during a graded test on cycle ergometer

10. Body Composition [Before and after 8 weeks of training]

    Measured by Dual energy x-ray absorptiometry

11. Endothelial cell characterization [Before and after 8 weeks of training]

    Assessment of protein and mRNA-levels of proteins of relevance for endothelial function

12. Skeletal muscle characterization [Before and after 8 weeks of training]

    Assessment of protein and mRNA-levels of proteins of relevance for skeletal muscle function

Eligibility Criteria

Criteria

• Ages Eligible for Study: 35 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Copenhagen	Copenhagen		Denmark	2100

Sponsors and Collaborators

• University of Copenhagen
• Lundbeck Foundation
• Danish Council for Independent Research

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ylva Hellsten, Professor, University of Copenhagen
• ClinicalTrials.gov Identifier: NCT03778489
• Other Study ID Numbers: PANX-HYP
• First Posted: Dec 19, 2018
• Last Update Posted: Oct 19, 2021
• Last Verified: Oct 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Ylva Hellsten, Professor, University of Copenhagen: Pannexin-1 channel
• Additional relevant MeSH terms: Hypertension; Essential Hypertension

Study Results

No Results Posted as of Oct 19, 2021