NCT03778489

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,

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 6, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 19, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

February 19, 2019

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2022

Completed
Last Updated

November 2, 2022

Status Verified

November 1, 2022

Enrollment Period

3.7 years

First QC Date

December 6, 2018

Last Update Submit

November 1, 2022

Conditions

Keywords

Pannexin-1 channel

Outcome Measures

Primary Outcomes (1)

  • Blood pressure

    Changes in systolic and diastolic blood pressure

    Before and after 8 weeks of training

Secondary Outcomes (12)

  • Pannexin channel function assessed in vivo

    Before and after 8 weeks of training

  • Pannexin channel distribution in skeletal muscle tissue

    Before and after 8 weeks of training

  • Sympathetic activity

    Before and after 8 weeks of training

  • Vascular function

    Before and after 8 weeks of training

  • Mitochondrial function in endothelial cells

    Before and after 8 weeks of training

  • +7 more secondary outcomes

Study Arms (2)

Hypertensive

EXPERIMENTAL

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

Other: Training

Control

ACTIVE COMPARATOR

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

Other: Training

Interventions

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

ControlHypertensive

Eligibility Criteria

Age35 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Copenhagen

Copenhagen, 2100, Denmark

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Essential Hypertension

Condition Hierarchy (Ancestors)

HypertensionVascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: Randomized double blinded case-control interventional study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 6, 2018

First Posted

December 19, 2018

Study Start

February 19, 2019

Primary Completion

November 1, 2022

Study Completion

November 1, 2022

Last Updated

November 2, 2022

Record last verified: 2022-11

Locations