Clinical trial NCT06823570: Anti-hypertensive Therapy and Exercise Treatment to Improve Vascular Health in Patients With Hypertension.
Official title: Anti-hypertensive Therapy and Exercise Treatment to Improve Vascular Health in Patients With Hypertension. A Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hypertension
Vascular Function
Fitness Testing
Metabolism Changes
Keywords: cardiorespiratory fitness
retinal microcirculation
endothelial function
exercise training
lifestyle treatment
Lead sponsor: Heinrich-Heine University, Duesseldorf
Sponsor class: OTHER
First posted: 2025-02-12
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial
Primary purpose: PREVENTION

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.

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)

Primary outcomes:
measure: 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.
timeFrame: From enrollment to the end of treatment after six month.
measure: Effect of an guideline based anti-hypertensive therapy on the retinal vessel diameters.
timeFrame: From enrollment to the end of treatment after six month.
Secondary outcomes:
measure: 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.
timeFrame: From enrollment to the end of treatment after six month.
measure: Effect of an guideline based anti-hypertensive therapy on the systolic and diastolic blood pressure.
timeFrame: From enrollment to the end of treatment after six month.
measure: 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.
timeFrame: From enrollment to the end of treatment after six month.
measure: Effect of an guideline based anti-hypertensive therapy on the microvascular endothelial function.
timeFrame: From enrollment to the end of treatment after six month.
measure: 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.
timeFrame: From enrollment to the end of treatment after six month.
measure: Effect of an guideline based anti-hypertensive therapy on arterial stiffness.
timeFrame: From enrollment to the end of treatment after six month.
measure: 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.
timeFrame: From enrollment to the end of treatment after six month.
measure: Effect of an guideline based anti-hypertensive therapy on physical fitness.
timeFrame: From enrollment to the end of treatment after six month.
measure: 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.
timeFrame: From enrollment to the end of treatment after six month.
measure: Effect of a guideline based anti-hypertensive therapy on the NO metabolism of stored blood samples.
timeFrame: From enrollment to the end of treatment after six month.
measure: 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.
timeFrame: From enrollment to the end of treatment after six month.
measure: Effect of a guideline based anti-hypertensive therapy on the metabolic profile of stored blood samples.
timeFrame: From enrollment to the end of treatment after six month.
measure: 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.
timeFrame: From enrollment to the end of treatment after six month.
measure: Effect of a guideline based anti-hypertensive therapy on systemic inflammation markers of stored blood samples.
timeFrame: From enrollment to the end of treatment after six month.
Other outcomes:
measure: 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.
timeFrame: From enrollment to the end of treatment after six month.
measure: Effect of a guideline based anti-hypertensive therapy on fat and muscle mass.
timeFrame: From enrollment to the end of treatment after six month.
measure: 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.
timeFrame: From enrollment to the end of treatment after six month.
measure: Effect of a guideline based anti-hypertensive therapy on intra- and extracellular water volume.
timeFrame: From enrollment to the end of treatment after six month.
Locations:
city: Düsseldorf
country: Germany
facility: Universitätsklinik Düsseldorf
Study officials:
References: