NCT06823570

Brief Summary

This is a prospective, monocentric, randomized controlled trial to investigate the effect of anti-hypertensive treatment and/or individualized exercise training intervention on blood pressure and vascular health. Furthermore the investigators want to decipher mechanisms, which contribute to vascular health by analyzing changes in metabolism and cell function in relation to vascular reaction.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable hypertension

Timeline
33mo left

Started Apr 2025

Longer than P75 for not_applicable hypertension

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Progress29%
Apr 2025Dec 2028

First Submitted

Initial submission to the registry

February 3, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 12, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2025

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2027

Expected
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Last Updated

March 12, 2025

Status Verified

February 1, 2025

Enrollment Period

2.2 years

First QC Date

February 3, 2025

Last Update Submit

March 11, 2025

Conditions

HypertensionVascular FunctionFitness TestingMetabolism Changes

Keywords

cardiorespiratory fitnessretinal microcirculationendothelial functionexercise traininglifestyle treatment

Outcome Measures

Primary Outcomes (2)

  • The additional effect of an anti-hypertensive treatment plus an individualizes exercise therapy on the retinal vessel diameters compared to a guideline based anti-hypertensive treatment with general lifestyle recommendations.

    The retinal vessel diameters will be analyzed based on the arteriolar-to-venular diameter ratio (AVR).

    From enrollment to the end of treatment after six month.

  • Effect of an guideline based anti-hypertensive therapy on the retinal vessel diameters.

    Changes of retinal vessel diameters will be analyzed based on the arteriolar-to-venular diameter ratio (AVR).

    From enrollment to the end of treatment after six month.

Secondary Outcomes (14)

  • The additional effect of an anti-hypertensive treatment plus an individualizes exercise therapy on the systolic and diastolic blood pressure compared to a guideline based anti-hypertensive treatment with general lifestyle recommendations.

    From enrollment to the end of treatment after six month.

  • Effect of an guideline based anti-hypertensive therapy on the systolic and diastolic blood pressure.

    From enrollment to the end of treatment after six month.

  • The additional effect of an anti-hypertensive treatment plus an individualizes exercise therapy on the microvascular endothelial function compared to a guideline based anti-hypertensive treatment with general lifestyle recommendations.

    From enrollment to the end of treatment after six month.

  • Effect of an guideline based anti-hypertensive therapy on the microvascular endothelial function.

    From enrollment to the end of treatment after six month.

  • The additional effect of an anti-hypertensive treatment plus an individualizes exercise therapy on the arterial stiffness compared to a guideline based anti-hypertensive treatment with general lifestyle recommendations.

    From enrollment to the end of treatment after six month.

  • +9 more secondary outcomes

Other Outcomes (4)

  • The additional effect of an anti-hypertensive treatment plus an individualizes exercise therapy on fat and muscle mass compared to a guideline based anti-hypertensive treatment with general lifestyle recommendations.

    From enrollment to the end of treatment after six month.

  • Effect of a guideline based anti-hypertensive therapy on fat and muscle mass.

    From enrollment to the end of treatment after six month.

  • The additional effect of an anti-hypertensive treatment plus an individualizes exercise therapy on intra- and extracellular water volume compared to a guideline based anti-hypertensive treatment with general lifestyle recommendations.

    From enrollment to the end of treatment after six month.

  • +1 more other outcomes

Study Arms (2)

Individualized exercise training group

ACTIVE COMPARATOR

Beside a guideline based anti-hypertensive therapy, patients in the intervention group will receive an individualized exercise training program 3x/week. Exercise training will be a combination of aerobic and resistance training and is based on each patient's individual fitness level. Regular contact between exercise physiologists and patients, as well as group sessions, will help patients to maintain a regular exercise program.

Behavioral: Individualized exercise therapyBehavioral: Lifestyle recommendations

Control group

OTHER

Beside a guideline based anti-hypertensive therapy, patients in the lifestyle recommendation group will receive general recommendations such as salt reduction, higher physical activity levels and stress reduction.

Behavioral: Lifestyle recommendations

Interventions

Individualized exercise therapyBEHAVIORAL

Patients in the intervention group will receive an individualized exercise training program 3x/week.

Individualized exercise training group
Lifestyle recommendationsBEHAVIORAL

The lifestyle recommendation group will receive general recommendations such as salt reduction, higher physical activity levels and stress reduction.

Control groupIndividualized exercise training group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- systolic hypertension grade I-II (BP values \>140 mmHg to \<180 mmHg) without anti-hypertensive medication treatment

You may not qualify if:

  • no written informed consent
  • age \<18 years
  • isolated diastolic hypertension
  • medical contraindications for the exercise treatment (for example orthopedic problems or an abnormal ECG during the cardio respiratory exercise test)
  • chronic eye diseases on both eyes (for example macular degeneration or glaucoma) or high intraocular pressure (\>20 mmHg)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitätsklinik Düsseldorf

Düsseldorf, Düsseldorf, 40225, Germany

RECRUITING

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Central Study Contacts

Johannes Stegbauer, Prof. Dr.

CONTACT

+49 211 81 080 74Studienzentrum-Nephrologie@med.uni-duesseldorf.de

Lukas Streese, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Randomized controlled trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 3, 2025

First Posted

February 12, 2025

Study Start

April 1, 2025

Primary Completion (Estimated)

May 31, 2027

Study Completion (Estimated)

December 31, 2028

Last Updated

March 12, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will share

Upon reasonable request, selected study data will be shared.

Locations

DE(1)