An observational study in Arterial Hypertension, Chronic Kidney Disease, Primary Aldosteronism and Arterial Stenosis, sponsored by Azienda Ospedaliera di Padova. Recruiting at 1 site in Italy. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-03.
Sponsored by Azienda Ospedaliera di Padova · Observational
High blood pressure (hypertension) is a leading cause of kidney damage, but detecting early kidney changes remains challenging with currently available tools. This study investigates whether kidney stiffness, measured by a non-invasive ultrasound technique called shear wave elastography (SWE), differs across different subtypes of hypertension and healthy volunteers, and whether it may serve as an early marker of hypertension-related kidney damage. Adults with essential hypertension, renovascular hypertension, and primary aldosteronism, as well as healthy volunteers, undergo kidney ultrasound with SWE measurements combined with standard clinical, laboratory, and vascular assessments, with the aim of identifying the independent factors influencing kidney stiffness and evaluating its potential role as a simple, painless, and widely available imaging biomarker of kidney damage
Arterial hypertension is a prevalent and multifactorial condition associated with progressive kidney damage through sustained glomerular hypertension, ischemia, and interstitial fibrosis - a process known as hypertensive nephrosclerosis. Beyond essential hypertension, secondary forms such as renovascular hypertension - most commonly caused by atherosclerotic renal artery stenosis or fibromuscular dysplasia - and primary aldosteronism, the most frequent cause of endocrine hypertension, are associated with distinct mechanisms of renal injury and represent potentially reversible or specifically treatable conditions.
Shear wave elastography (SWE) is a non-invasive, quantitative, real-time ultrasound-based technique that measures tissue stiffness by generating and tracking shear wave propagation through tissue, expressed as Young's modulus in kilopascals (kPa). While renal SWE has shown promise as a surrogate marker of renal parenchymal fibrosis in chronic kidney disease, its relationship with hemodynamic factors - including arterial perfusion pressure, renal blood flow, and venous congestion - is complex and not yet fully understood. The independent contribution of specific hypertension determinants to renal cortical stiffness has not been systematically investigated.
The K-STRESS study (Kidney Shear wave elasTography for REnal Stiffness in SyStemic hypertension) is a single-centre, prospective, observational pilot study conducted at the Radiology Institute of the University of Padova. Adult patients with arterial hypertension undergoing renal artery Doppler ultrasound as part of their routine diagnostic workup are prospectively enrolled alongside a control group of healthy volunteers. At the time of ultrasound examination, SWE measurements are obtained at multiple sites in both kidneys, and standard liver SWE is also recorded as a technical reference. Comprehensive anthropometric, clinical, biochemical, and vascular data are collected for each participant.
Within the hypertensive cohort, participants are clinically classified into three subgroups - essential hypertension, renovascular hypertension, and primary aldosteronism - based on the results of their diagnostic workup, allowing comparison of renal SWE values across different hypertensive subtypes.
The primary aim of the study is to identify the independent predictors of renal cortical stiffness among a wide range of clinical, anthropometric, hemodynamic, and biochemical variables in a well-characterized hypertensive population undergoing standardized diagnostic evaluation. Secondary aims include the comparison of renal SWE values between hypertensive patients and healthy controls, and across the three hypertensive subgroups.
If validated, renal SWE may provide a simple, non-invasive, and widely available imaging tool for the early detection and monitoring of hypertension-related kidney damage, with potential implications for risk stratification and clinical management of hypertensive patients.
6,114 studies on the registry are indexed under Hypertension; 912 are open to participants now.
This study's planned enrollment of 240 is below the median of 350 across 1,163 observational studies indexed under Hypertension.
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hypertensive patients
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Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
normotensive individuals
patients with essential hypertension
hypertensive patients with primary aldosteronism
hypertensive patients with renal arterial stenosis
Mean renal cortical stiffness measured by shear wave elastography (SWE), expressed in kilopascals (kPa)
Renal cortical stiffness (Young's modulus) will be measured by real-time SWE during renal artery Doppler ultrasound, using a 4 mm ROI placed in the cortex (≥1 cm below the capsule, avoiding pyramids). Six measurements per kidney (2 per pole: upper, mid, lower) will be acquired, for a total of 12 per patient. The reported value is the arithmetic mean of all 12 measurements per participant. Kidney-level means (6 measurements each) will be used for laterality analyses. This value will be used as the dependent variable in a multivariable linear model to assess its independent association with clinical, anthropometric, biochemical and Doppler covariates.
Time frame: At baseline, single assessment during the renal Doppler ultrasound exam (day 0).
Difference in mean renal cortical stiffness (kPa) between hypertensive patients and healthy controls
Mean of 12 SWE measurements per participant, compared between groups.
Time frame: Baseline (day 0).
Difference in mean renal cortical stiffness (kPa) between hypertensive patients with and without renal artery stenosis
Mean SWE value per participant (and kidney-level means for ipsilateral vs. contralateral comparison). Stenosis defined by Doppler ultrasound and/or CT angiography.
Time frame: Baseline (day 0).
Difference in mean renal cortical stiffness (kPa) between hypertensive patients with and without primary aldosteronism
Mean of 12 SWE measurements per participant. Primary aldosteronism is biochemically confirmed.
Time frame: Baseline (day 0).
Plan to share: Undecided
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Azienda Ospedaliera di Padova