Hypertension, Vascular Function, Fitness Testing, Metabolism Changes
Conditions
Keywords
cardiorespiratory fitness, retinal microcirculation, endothelial function, exercise training, lifestyle treatment
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.
Interventions
BEHAVIORALIndividualized exercise therapy
Patients in the intervention group will receive an individualized exercise training program 3x/week.
BEHAVIORALLifestyle recommendations
The lifestyle recommendation group will receive general recommendations such as salt reduction, higher physical activity levels and stress reduction.
Sponsors
Heinrich-Heine University, Duesseldorf
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Caregiver, Outcomes Assessor)
Intervention model description
Randomized controlled trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 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). |
| Effect of an guideline based anti-hypertensive therapy on the retinal vessel diameters. | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 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). |
| 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. | 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. |
| Effect of a guideline based anti-hypertensive therapy on the metabolic profile of stored blood samples. | 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. |
| 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. | 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. |
| Effect of a guideline based anti-hypertensive therapy on systemic inflammation markers of stored blood samples. | 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. |
| 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. | Changes in unattended systolic and diastolic blood pressure in mm Hg. |
| 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. | Changes in unattended systolic and diastolic blood pressure in mm Hg. |
| 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. | Changes in microvascular endothelial function will be analyzed by retinal arteriolar and venular flicker light-induced dilation. |
| Effect of an guideline based anti-hypertensive therapy on the microvascular endothelial function. | 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. |
| 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. | Changes in arterial stiffness will be analyzed based on the central pulse wave velocity. |
| Effect of an guideline based anti-hypertensive therapy on arterial stiffness. | From enrollment to the end of treatment after six month. | Changes in arterial stiffness will be analyzed based on the central pulse wave velocity. |
| Effect of an guideline based anti-hypertensive therapy on physical fitness. | 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). |
| 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. | 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. |
| Effect of a guideline based anti-hypertensive therapy on the NO metabolism of stored blood samples. | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Effect of a guideline based anti-hypertensive therapy on intra- and extracellular water volume. | From enrollment to the end of treatment after six month. | Changes in intra- and extracellular water volume will be investigated by bioimpedance analysis. |
| 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. | Changes in fat and muscle mass will be investigated by bioimpedance analysis. |
| Effect of a guideline based anti-hypertensive therapy on fat and muscle mass. | From enrollment to the end of treatment after six month. | Changes in fat and muscle mass will be investigated by bioimpedance analysis. |
| 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. | Changes in intra- and extracellular water volume will be investigated by bioimpedance analysis. |
Countries
Germany
Contacts
Primary ContactJohannes Stegbauer, Prof. Dr.
Backup ContactLukas Streese, PhD
Outcome results
None listed