Anti-hypertensive Therapy and Exercise Treatment to Improve Vascular Health in Patients With Hypertension.

NCT ID: NCT06823570

Last Updated: 2025-03-12

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-01
• Study Completion Date: 2028-12-31

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.

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.

Conditions

Hypertension; Vascular Function; Fitness Testing; Metabolism Changes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Individualized exercise therapy

Intervention Type: BEHAVIORAL

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

Lifestyle recommendations

Intervention Type: BEHAVIORAL

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

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.

Group Type: OTHER

Lifestyle recommendations

Intervention Type: BEHAVIORAL

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

Interventions

Individualized exercise therapy

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

Intervention Type: BEHAVIORAL

Lifestyle recommendations

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Heinrich-Heine University, Duesseldorf

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Universitätsklinik Düsseldorf

Düsseldorf, Düsseldorf, Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Johannes Stegbauer, Prof. Dr.

Role: CONTACT

Studienzentrum-Nephrologie@med.uni-duesseldorf.de

+49 211 81 080 74

Lukas Streese, PhD

Role: CONTACT

Facility Contacts

Lukas Streese, PhD

Role: primary

Studienzentrum-Nephrologie@med.uni-duesseldorf.de

+49 211 81 080 74

Other Identifiers

2023-2603

Identifier Type: -

Identifier Source: org_study_id