Examining how midlife hypertension affects brain health
Midlife Hypertension and Structural and Functional Brain MRI: Catching the First Signs of Cerebral Small Vessel Disease
This study is testing how high blood pressure affects brain health in young adults aged 18-55 who don't have major brain problems yet.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 130 (estimated) |
| Ages | 18 Years to 55 Years |
| Sex | All |
| Sponsor | Radboud University Medical Center Academic / other |
| Locations | 1 site (Nijmegen) |
| Trial ID | NCT06175663 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the relationship between hypertension and small vessel cerebrovascular disease (SVD) in young adults. It aims to explore abnormalities in brain microstructure and vascular function in individuals aged 18-55 with high blood pressure, particularly focusing on those largely free of SVD. The study will include both cross-sectional and longitudinal assessments, with participants undergoing antihypertensive medication withdrawal to analyze the effects on their brain health. The goal is to better understand the mechanisms by which hypertension contributes to vascular pathology before significant brain lesions develop.
Who should consider this trial
Good fit: Ideal candidates for this study are young adults aged 18-55 with hypertension, specifically those with blood pressure readings above 140/90 mmHg.
Not a fit: Patients with pre-existing cerebrovascular disease or significant neurological/psychiatric conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and management of hypertension-related brain health issues, potentially reducing the risk of strokes and dementia.
How similar studies have performed: While there have been studies on hypertension and brain health, this specific approach focusing on young adults and the early mechanisms of SVD is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Study 1: cross-sectional study Inclusion Criteria: * Age 18-40 years * Blood pressure above 140/90 mmHg, measured within three months prior to study participation Exclusion Criteria: * Pre-existing cerebrovascular disease * Pregnancy * Contraindications for 3 T MRI * Renal function eGFR below 30 ml/min (for Dynamic Contrast Enhanced \[DCE\]-MRI * Major risk factors for acute ischemic stroke other than SVD according to the TOAST criteria, including, but not limited to, large-artery atherosclerosis, cardioembolism and vasculitis based on medical history and ultrasound of the carotids collected at baseline or any chronic disease that could lead to brain lesions mimicking SVD * Major (neurological/psychiatric) disease (e.g. multiple sclerosis) * Not able to give informed consent Study 2: longitudinal study Inclusion criteria: * Age 18-55 years * Undergoing diagnostic routine of temporary antihypertensive withdrawal for biochemical analysis as part of clinical work-up Exclusion criteria: * Pre-existing cerebrovascular disease * Pregnancy * Contraindications for 3 T MRI * Renal function eGFR below 30 ml/min (for Dynamic Contrast Enhanced \[DCE\]-MRI * Major risk factors for acute ischemic stroke other than SVD according to the TOAST criteria,22 including, but not limited to, large-artery atherosclerosis, cardioembolism and vasculitis based on medical history and ultrasound of the carotids collected at baseline or any chronic disease that could lead to brain lesions mimicking SVD * Major (neurological/psychiatric) disease (e.g. multiple sclerosis) * Not able to give informed consent
Where this trial is running
Nijmegen
- RadboudUMC — Nijmegen, Netherlands (Recruiting)
Study contacts
- Principal investigator: Frank-Erik de Leeuw — Radboud University Medical Center
- Study coordinator: Esther Janssen
- Email: esther.janssen@radboudumc.nl
- Phone: +31651758279
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.