AzTrials
AzTrials

Hypertension,EssentialIMPROVEHNCT03778489

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

A study testing Training in people with Hypertension,Essential, run by University of Copenhagen at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 35 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Hypertension,Essential
What is being tested?
Training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteDenmark
Study dates
19 Feb 2019to 1 Nov 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 35 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Denmark1 site

  • University of Copenhagen

    Copenhagen, 2100

Other trials in Denmark

About this study

Official title: Impact of Aerobic Exercise Training on Sympathetically Mediated Vasoconstriction and Vascular Function in Individuals With Essential Hypertension (IMPROVEH)

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,

Being tested
Training
Keywords
Pannexin-1 channel
Medical subject headings
Essential Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TrainingOther

    10 weeks of high intensity exercise training. 2-3 trainings per week of approx. 40 min.

Study groups in NCT03778489
Study groupRoleWhat they receive
HypertensiveExperimentalMen and women in age-group 35-65 years Resting blood pressure of >140/90 mmHg non or only anti-hypertensive medication
Receives: Other: Training
ControlActive comparatorMen and women in age-group 35-65 years Resting blood pressure of <140/90 mmHg no medication
Receives: Other: Training

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Blood pressure

    Changes in systolic and diastolic blood pressure

    Measured: Before and after 8 weeks of training

Secondary outcomes (12)

  1. Pannexin channel function assessed in vivo

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

    Measured: Before and after 8 weeks of training

  2. Pannexin channel distribution in skeletal muscle tissue

    Pannexin channel distribution is assessed immunohistochemically in muscle samples

    Measured: Before and after 8 weeks of training

  3. Sympathetic activity

    Direct measurement of Muscle Sympathetic Nervous Activity via microneurography

    Measured: Before and after 8 weeks of training

  4. Vascular function

    Vascular conductance measured by ultrasound doppler during infusion of vasoactive substances

    Measured: Before and after 8 weeks of training

  5. Mitochondrial function in endothelial cells

    Endothelial cell mitochondrial respiration is measured by High Resolution Respirometry

    Measured: Before and after 8 weeks of training

  6. Reactive oxygen species formation in in endothelial cells

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

    Measured: Before and after 8 weeks of training

  7. Rheology

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

    Measured: Before and after 8 weeks of training

  8. Platelet reactivity

    Platelet reactivity is assessed by multiplate aggregometry

    Measured: Before and after 8 weeks of training

  9. Maximal oxygen uptake

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

    Measured: Before and after 8 weeks of training

  10. Body Composition

    Measured by Dual energy x-ray absorptiometry

    Measured: Before and after 8 weeks of training

  11. Endothelial cell characterization

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

    Measured: Before and after 8 weeks of training

  12. Skeletal muscle characterization

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

    Measured: Before and after 8 weeks of training

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Dec 2018
  2. Study start19 Feb 2019
  3. Primary completion1 Nov 2022
  4. Study completion1 Nov 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized double blinded case-control interventional study
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03778489
Sponsor's protocol ID
PANX-HYP
Acronym
IMPROVEH
Status last verified
Nov 2022
First submitted
6 Dec 2018
Last updated
2 Nov 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: Currently awaiting instructions on this issue from the department

Publications

  • 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.

    PubMed 35420578

Questions about this trial

What is this clinical trial studying?

A study testing Training in people with Hypertension,Essential, run by University of Copenhagen at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Blood pressure (time frame: Before and after 8 weeks of training). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03778489, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2022.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in