Resistant Hypertension
Conditions
Keywords
physical exercise, blood pressure, proteomics, resistant hypertension
Brief summary
This study will examine the effects of 4 months of aerobic interval training versus continuous aerobic training on ambulatory blood pressure (ABP) and novel plasma protein biomarkers in patients with resistant hypertension. A randomized controlled trial will be performed including two exercise groups and a control group: a) moderate-intensity interval training (MIIT); b) moderate-intensity continuous training (MICT); c) usual care. MIIT could represent a superior training modality that exceeds the benefits of MICT in patients with resistant hypertension.
Detailed description
Hypertension is associated with an increased risk of cardiovascular morbidity and mortality, and its high prevalence remains a worldwide concern. Ambulatory blood pressure monitoring (ABPM) is recognized in the diagnosis and management of hypertension, and can control blood pressure better than clinic assessment. Different studies have examined the effects of aerobic training on ABP in patients with hypertension, but the effects of moderate-intensity interval training (MIIT) and moderate-intensity continuous training (MICT) on ABP and novel plasma protein biomarkers that could potentially serve to identify cardiovascular risk, have not yet been examined in patients with resistant hypertension.To fill this gap, our aims are to determine the effects of MIIT and MICT for 4 months on ABP (primary endpoint), and on proteomic biomarkers (secondary endpoints) in patients with resistant hypertension. A total of 72 participants will be randomly divided into three groups: the first group (n=24) will perform MIIT, the second group (n=24) will perform MICT, and the third control group (n=24) will maintain usual care for 4 months. All will receive usual care for 4 months, with the structured physical exercise as the only relevant change in the intervention groups.
Interventions
MIIT group: participants will perform 3 sessions per week for 4 months. Each session will involve a ∼3 min warm-up (joint mobility exercises and walking at ∼2.2 METs), a ∼40-50 min main period (∼6-7 reps of 4 min at ∼4.2 METs, with 3 min of active recovery at ∼2.2 METs between each interval), and a ∼3-min cool-down (joint mobility exercises and walking at ∼2.2 METs). We will select the same aerobic dose of training (i.e., kcal/kg of body weight per week) to match total energy expenditure in both exercise groups.
MICT group: participants will perform 3 sessions per week for 4 months. Each session will involve a ∼3 min warm-up (joint mobility exercises and walking at ∼2.2 METs), a ∼40-50 min main period at ∼3.2 METs, and a ∼3-min cool-down (joint mobility exercises and walking at ∼2.2 METs).
Sponsors
Universidad Europea de Madrid
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, Outcomes Assessor)
Masking description
Care providers and outcomes assessors will be blinded to group allocation.
Intervention model description
The sample of this study will be randomized in a 1:1:1 ratio (www.randomizer.org) based on a computer-generated random allocation sequence, and will be concealed using sequentially numbered, opaque, sealed envelopes to MIIT, MICT and control groups.
Eligibility
Sex/Gender
ALL
Age
30 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Patients with resistant hypertension (RH) (i.e., systolic BP/diastolic BP \>130/80 mmHg according to the American College of Cardiology/American Heart Association) despite the concurrent use of three or more antihypertensive drugs - commonly including a diuretic, a long-acting calcium channel blocker, and a blocker of the renin-angiotensin system. RH also includes patients whose BP achieves target values on ≥ 4 antihypertensive. medications (i.e., 'controlled' RH). * Adherence to prescribed medications. * Willing to be randomized to one of the 3 groups. * Informed consent.
Exclusion criteria
*
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in 24-hour ambulatory blood pressure | Baseline to immediate post-treatment (4 months) | Ambulatory SBP and DBP will be recorded with a validated oscillometric device over 24 hours. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in plasma proteome | Baseline to immediate post-treatment (4 months) | Olink's Proximity Extension Assay (PEA) technology, using the inflammation panel, will be used to evaluate changes in the plasma proteome. |
| Changes in albuminuria | Baseline to immediate post-treatment (4 months) | Albuminuria will be determined from the albumin/creatinine ratio in urine. |
| Changes in glomerular filtration rate | Baseline to immediate post-treatment (4 months) | The estimated glomerular filtration rate (eGFR) will be determined from serum creatinine levels using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in echocardiography-determined relative wall thickness (RWT) | Baseline to immediate post-treatment (4 months) | The RWT will be calculated using the following formula: RWT = (Interventricular septum + left ventricular posterior wall thickness)/Left ventricular end-diastolic diameter). |
| Change in echocardiography-determined left ventricular global longitudinal strain (LV-GLS) | Baseline to immediate post-treatment (4 months) | Two-dimensional speckle tracking echocardiography will be used to determine LV-GLS The Auto Strain function will be used for out-of-cart strain assessment on saved records. GLS values will be obtained by analyzing multi-camera perspectives, including two-, three- and four-camera views. |
| Change in echocardiography-determined left ventricular end-diastolic diameter (LVEDD) | Baseline to immediate post-treatment (4 months) | LVEDD will be measured using two-dimensional guided M-mode imaging following recommendations from the American Society of Echocardiography. |
| Change in echocardiography-determined left ventricular (LV) mass | Baseline to immediate post-treatment (4 months) | LV dimensions will be expressed relative to body surface area (in m x\^2). |
| Change in echocardiography-determined left ventricular end- diastolic volume (LVEDV) | Baseline to immediate post-treatment (4 months) | We will use the following equation to measure LVEDV: LVEDV (mL) = \[7.0/(2.4 + Left ventricular end-diastolic diameter)\] × Left ventricular end-diastolic diameter x\^3. |
| Change in aerobic capacity | Baseline to immediate post-treatment (4 months). | VO2 will be measured breath-by-breath using a gas exchange analysis system. |
| Change in echocardiography-determined left ventricular posterior wall thickness (LVPW) (diastole) | Baseline to immediate post-treatment (4 months) | LVPW will be measured using two-dimensional guided M-mode imaging following recommendations from the American Society of Echocardiography. |
| Change in carotid intima-media thickness (IMT) | Baseline to immediate post-treatment (4 months) | The IMT will be measured in a long axis view in each distal common carotid artery, at least 5 mm proximal to the bifurcation, as the mean distance between the luminal-intimal and the medial-adventitial interfaces over a 10-mm length in the far wall. |
| Change in femoral intima-media thickness (IMT) | Baseline to immediate post-treatment (4 months) | The IMT will be measured in a long axis view in each distal common carotid artery, at least 5 mm proximal to the bifurcation, as the mean distance between the luminal-intimal and the medial-adventitial interfaces over a 10-mm length in the far wall. |
| Change in carotid plaque maximal thickness | Baseline to immediate post-treatment (4 months) | A plaque will be defined as the presence of a focal wall thickening ≥50% greater than the surrounding vessel wall, a focal region with an IMT measurement ≥1.5 mm, or a ≥0.5 cm protrusion into the lumen exceeding the IMT. |
| Change in femoral plaque maximal thickness | Baseline to immediate post-treatment (4 months) | A plaque will be defined as the presence of a focal wall thickening ≥50% greater than the surrounding vessel wall, a focal region with an IMT measurement ≥1.5 mm, or a ≥0.5 cm protrusion into the lumen exceeding the IMT. |
| Change in echocardiography-determined interventricular septal wall thickness (IVS) | Baseline to immediate post-treatment (4 months) | IVS will be measured using two-dimensional guided M-mode imaging following recommendations from the American Society of Echocardiography. |
| Change in body composition | Baseline to immediate post-treatment (4 months) | Dual-energy X-ray absorptiometry (DXA) scans will performed to measure body composition (fat mass and lean mass). |
| Change in lipid profiles | Baseline to immediate post-treatment (4 months). | Blood analysis will be performed to evaluate HDL-C, LDL-C, total cholesterol, and triglyceride levels. |
| Change in echocardiography-determined left ventricular ejection fraction | Baseline to immediate post-treatment (4 months). | The percentage of blood volume ejected from the left ventricle with each systolic contraction \[(left ventricular end-diastolic volume - left-ventricular end-systolic volume)/ left ventricular end-diastolic volume\] × 100. |
Countries
Spain
Outcome results
None listed