Anti-hypertensive Therapy and Exercise Treatment to Improve Vascular Health in Patients with Hypertension. (Antitension)

March 11, 2025 updated by: Heinrich-Heine University, Duesseldorf

Anti-hypertensive Therapy and Exercise Treatment to Improve Vascular Health in Patients with Hypertension. a Randomized Controlled Trial.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Arterial hypertension is a global health burden that affects the structure and function of large and small blood vessels and induces disease-specific end-organ damage. Exercise therapy is highly recommended in the treatment of arterial hypertension to reduce blood pressure and ameliorate hypertension-induced vascular damage. Previous exercise intervention studies have shown that exercise treatment improves vascular dysfunction independently of changes in blood pressure. Several sensitive vascular biomarkers exist that could optimize risk stratification and therapeutic decisions based on the progression of individual vascular damage in patients with arterial hypertension. However, individualized vascular assessment during anti-hypertensive treatment is not yet part of routine clinical practice. In order to improve clinical decision making from a personalized medicine perspective, it is essential to better understand which vascular biomarkers have the best sensitivity in detecting therapy-induced vascular adaptations and whether anti-hypertensive therapy with or without additional exercise improves vascular health in patients with hypertension. The proposed study will evaluate the effects of guideline-directed anti-hypertensive therapy with or without individualized exercise training intervention in 60 patients with hypertension and no previous medical treatment for one year. Regular outpatient assessments of blood pressure and large and small blood vessels will be performed every two months. Anti-hypertensive therapy will be based on the current guidelines of the European Society of Hypertension. The investigators aim to achieve the target blood pressure after six months of treatment. A further six-month follow-up is planned to assess the long-term effects of anti-hypertensive therapy, with or without additional individualized exercise training intervention, on blood pressure and macro- and microvascular health. In addition, the investigators will investigate the effect of metabolic changes induced by anti-hypertensive treatment or individualized exercise training intervention on vascular health.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Lukas Streese, PhD

Study Locations

  • Germany
      • Düsseldorf, Germany, 40225
        • Recruiting
        • Universitätsklinik Düsseldorf
        • Contact:
          • Lukas Streese, PhD
        • Contact:
        • Contact:
          • Johannes Stegbauer, MD
        • Contact:
          • Claudia Schmidt, PhD
        • Contact:
          • Marta Kantauskaite, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Individualized exercise training group
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 therapy
Patients in the intervention group will receive an individualized exercise training program 3x/week.
Behavioral: Lifestyle recommendations
The lifestyle recommendation group will receive general recommendations such as salt reduction, higher physical activity levels and stress reduction.
Other: Control group
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
The lifestyle recommendation group will receive general recommendations such as salt reduction, higher physical activity levels and stress reduction.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Time Frame: From enrollment to the end of treatment after six month.
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.
Time Frame: From enrollment to the end of treatment after six month.
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Time Frame: From enrollment to the end of treatment after six month.
Changes in unattended systolic and diastolic blood pressure in mm Hg.
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.
Time Frame: From enrollment to the end of treatment after six month.
Changes in unattended systolic and diastolic blood pressure in mm Hg.
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.
Time Frame: From enrollment to the end of treatment after six month.
Changes in microvascular endothelial function will be analyzed by retinal arteriolar and venular flicker light-induced dilation.
From enrollment to the end of treatment after six month.
Effect of an guideline based anti-hypertensive therapy on the microvascular endothelial function.
Time Frame: From enrollment to the end of treatment after six month.
Changes in microvascular endothelial function will be analyzed by retinal arteriolar and venular flicker light-induced dilation.
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.
Time Frame: From enrollment to the end of treatment after six month.
Changes in arterial stiffness will be analyzed based on the central pulse wave velocity.
From enrollment to the end of treatment after six month.
Effect of an guideline based anti-hypertensive therapy on arterial stiffness.
Time Frame: From enrollment to the end of treatment after six month.
Changes in arterial stiffness will be analyzed based on the central pulse wave velocity.
From enrollment to the end of treatment after six month.
The additional effect of an anti-hypertensive treatment plus an individualizes exercise therapy on physical fitness compared to a guideline based anti-hypertensive treatment with general lifestyle recommendations.
Time Frame: From enrollment to the end of treatment after six month.
Changes of physical fitness will be analyzed based on cardiopulmonary exercise tests to evaluate peak oxygen uptake (VO2peak).
From enrollment to the end of treatment after six month.
Effect of an guideline based anti-hypertensive therapy on physical fitness.
Time Frame: From enrollment to the end of treatment after six month.
Changes of physical fitness will be analyzed based on cardiopulmonary exercise tests to evaluate peak oxygen uptake (VO2peak).
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 NO metabolism of stored blood samples compared to a guideline based anti-hypertensive treatment with general lifestyle recommendations.
Time Frame: From enrollment to the end of treatment after six month.
Changes of the NO metabolism will be analyzed based on nitrite, nitrate, ADMA and SDMA with nuclear magnetic resonance spectroscopy and established ELISA kits based on collected and stored blood samples.
From enrollment to the end of treatment after six month.
Effect of a guideline based anti-hypertensive therapy on the NO metabolism of stored blood samples.
Time Frame: From enrollment to the end of treatment after six month.
Changes of the NO metabolism will be analyzed based on nitrite, nitrate, ADMA and SDMA with nuclear magnetic resonance spectroscopy and established ELISA kits based on collected and stored blood samples.
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 metabolic profile of stored blood samples compared to a guideline based anti-hypertensive treatment with general lifestyle recommendations.
Time Frame: From enrollment to the end of treatment after six month.
Changes of the metabolic profile of stored blood samples will be analyzed by liquid chromatography and high-resolution tandem mass spectrometry.
From enrollment to the end of treatment after six month.
Effect of a guideline based anti-hypertensive therapy on the metabolic profile of stored blood samples.
Time Frame: From enrollment to the end of treatment after six month.
Changes of the metabolic profile of stored blood samples will be analyzed by liquid chromatography and high-resolution tandem mass spectrometry.
From enrollment to the end of treatment after six month.
The additional effect of an anti-hypertensive treatment plus an individualizes exercise therapy on systemic inflammation markers compared to a guideline based anti-hypertensive treatment with general lifestyle recommendations.
Time Frame: From enrollment to the end of treatment after six month.
Changes of systemic inflammation markers, such as cytokines, will be analyzed by ELISA and OLINK based on stored blood samples.
From enrollment to the end of treatment after six month.
Effect of a guideline based anti-hypertensive therapy on systemic inflammation markers of stored blood samples.
Time Frame: From enrollment to the end of treatment after six month.
Changes of systemic inflammation markers, such as cytokines, will be analyzed by ELISA and OLINK based on stored blood samples.
From enrollment to the end of treatment after six month.

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Time Frame: From enrollment to the end of treatment after six month.
Changes in fat and muscle mass will be investigated by bioimpedance analysis.
From enrollment to the end of treatment after six month.
Effect of a guideline based anti-hypertensive therapy on fat and muscle mass.
Time Frame: From enrollment to the end of treatment after six month.
Changes in fat and muscle mass will be investigated by bioimpedance analysis.
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.
Time Frame: From enrollment to the end of treatment after six month.
Changes in intra- and extracellular water volume will be investigated by bioimpedance analysis.
From enrollment to the end of treatment after six month.
Effect of a guideline based anti-hypertensive therapy on intra- and extracellular water volume.
Time Frame: From enrollment to the end of treatment after six month.
Changes in intra- and extracellular water volume will be investigated by bioimpedance analysis.
From enrollment to the end of treatment after six month.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Heinrich-Heine University, Duesseldorf

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 31, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 3, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 7, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 11, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2023-2603

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Upon reasonable request, selected study data will be shared.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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