Resistant Hypertension Clinical Trial
Official title:
Effects of Two Types of Aerobic Training on Ambulatory Blood Pressure in Hypertensives: a Systems Biology Approach
NCT number | NCT05563077 |
Other study ID # | UEM |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | October 5, 2022 |
Est. completion date | August 2025 |
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. In addition, we will measure ABP after a training cessation period of 3 months (i.e., 7 months follow-up). 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.
Status | Recruiting |
Enrollment | 72 |
Est. completion date | August 2025 |
Est. primary completion date | August 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 30 Years to 70 Years |
Eligibility | 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: - Exclusion criteria will include exercising more than 20 minutes on 3 days or more weekly. - Severe ischemic heart disease, major psychiatric disorder and other health contraindications that may interfere in the evaluations or interventions. |
Country | Name | City | State |
---|---|---|---|
Spain | Universidad Europea Madrid (UEM) | Madrid |
Lead Sponsor | Collaborator |
---|---|
Universidad Europea de Madrid |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Change in flow-mediated dilation | Ultrasound imaging of the brachial artery will be performed. | Baseline to immediate post-treatment (4 months) | |
Other | Change in aerobic capacity | VO2 will be measured breath-by-breath using a gas exchange analysis system. | Baseline to immediate post-treatment (4 months) | |
Other | Change in body composition | Dual-energy X-ray absorptiometry (DXA) scans will performed to measure body composition (fat mass and lean mass). | Baseline to immediate post-treatment (4 months) | |
Other | Change in lipid profiles | Blood analysis will be performed to evaluate HDL-C, LDL-C, total cholesterol, and triglyceride levels. | Baseline to immediate post-treatment (4 months). | |
Primary | Change in 24-hour ambulatory blood pressure | Ambulatory SBP and DBP will be recorded with a validated oscillometric device over 24 hours. | Baseline to immediate post-treatment (4 months) and after 3 months (7 months) | |
Secondary | Change in plasma proteome | It will be used liquid chromatography coupled to tandem mass spectrometry. | Baseline to immediate post-treatment (4 months) |
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