Prehypertension Clinical Trial
Official title:
Dietary Management and Aerobic Exercise on 24-hour Ambulatory Blood Pressure in Subjects With Prehypertension: Randomized, Single-blinded Clinical Trial
NCT number | NCT05274971 |
Other study ID # | Daphne |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | May 15, 2022 |
Est. completion date | February 1, 2024 |
Verified date | April 2024 |
Source | Korea University Anam Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is a multicenter, randomized, single-blinded clinical trial investigating the effect of dietary management and active aerobic exercise training on reduction of 24-hour ambulatory blood pressure in subjects with prehypertension.
Status | Completed |
Enrollment | 70 |
Est. completion date | February 1, 2024 |
Est. primary completion date | November 1, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria: - Age 18-80 years - Prehypertension defined as a systolic blood pressure of 130 to 139 mm Hg and/or a diastolic blood pressure of 85 to 89 mm Hg - Patients without previous use of anti-hypertensive medication within 4 weeks of enrollment Exclusion Criteria: - Patients under anti-hypertensive medications - Patients with suspected or confirmed secondary hypertension - Patients with abnormal liver function tests (transaminases more than three times the upper limit of normal) - Patients without aerobic exercise tolerance - Patients under hormone replacement therapy or other steroids - Patients with peripheral edemas and/or baseline serum creatinine level above 2.0 mg/dL - Patients with medical conditions that potentially affect blood pressure, including neurological disorders, gastrointestinal diseases, or malignancy. |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Korea University Anam Hospital | Seoul |
Lead Sponsor | Collaborator |
---|---|
Korea University Anam Hospital | The Korean Vascular Research Working Group |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in 24-hour ambulatory systolic blood pressure | Change in 24-hour ambulatory systolic blood pressure | from baseline to 12 weeks | |
Primary | Change in 24-hour ambulatory diastolic blood pressure | Change in 24-hour ambulatory diastolic blood pressure | from baseline to 12 weeks | |
Primary | Change in daytime ambulatory systolic and diastolic blood pressure | Change in daytime ambulatory systolic and diastolic blood pressure | from baseline to 12 weeks | |
Primary | Change in nighttime ambulatory systolic and diastolic blood pressure | Change in nighttime ambulatory systolic and diastolic blood pressure | from baseline to 12 weeks | |
Primary | Change in office systolic and diastolic blood pressure | Change in office systolic and diastolic blood pressure | from baseline to 12 weeks | |
Secondary | Change in arterial stiffness | augmentation index | from baseline to 12 weeks | |
Secondary | Change in arterial stiffness | pulse wave velocity | from baseline to 12 weeks | |
Secondary | Change in serum renin level | Change in serum renin level | from baseline to 12 weeks | |
Secondary | Change in serum angiotensin converting enzyme (ACE) level | Change in serum angiotensin converting enzyme (ACE) level | from baseline to 12 weeks | |
Secondary | Change in circulating endothelial and inflammatory biomarkers | interleukin-6 | from baseline to 12 weeks | |
Secondary | Change in circulating endothelial and inflammatory biomarkers | interleukin-18 | from baseline to 12 weeks | |
Secondary | Change in circulating endothelial and inflammatory biomarkers | Tumour Necrosis Factor alpha | from baseline to 12 weeks | |
Secondary | Change in circulating endothelial and inflammatory biomarkers | high sensitivity-C-reactive protein | from baseline to 12 weeks | |
Secondary | Change in circulating endothelial and inflammatory biomarkers | Soluble Vascular Cell Adhesion Molecule-1 (sVCAM-1) | from baseline to 12 weeks | |
Secondary | Change in circulating endothelial and inflammatory biomarkers | Soluble intercellular adhesion molecule-1 (sICAM-1) | from baseline to 12 weeks | |
Secondary | Change in circulating endothelial and inflammatory biomarkers | Plasminogen activator inhibitor-1 | from baseline to 12 weeks |
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