Arterial Hypertension, Chronic Kidney DiseaseK-STRESSNCT07914075
Kidney Stiffness Measured by Ultrasound in Patients With High Blood Pressure and Healthy Volunteers
An observational study of Arterial Hypertension, Chronic Kidney Disease and Primary Aldosteronism, run by Azienda Ospedaliera di Padova at 1 site in Italy.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Arterial Hypertension, Chronic Kidney Disease, Primary Aldosteronism, Arterial Stenosis
- How many people
- 240 participants
- Where
- 1 siteItaly
- Study dates
- 11 Aug 2026to 31 Jan 2029
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: hypertensive patients
Who may be able to join
- Adults ≥18 y
- Informed consent signed
- diagnosis of essential or secondary hypertension or willingness to participate as healthy controls
Who cannot join
- Known parenchymal renal disease other than hypertensive nephrosclerosis, including but not limited to glomerulonephritis, polycystic kidney disease, congenital nephropathy, and storage/infiltrative diseases (e.g. amyloidosis, Fabry disease), as classified according to KDIGO 2024 CKD guidelines (the presence of diabetes mellitus, cardiovascular disease, or peripheral artery disease does not constitute an exclusion criterion)
- patients with urinary tract obstruction
- renal transplant recipients
- pregnant women
- BMI >40
- Kidney lesions such as renal stones/mass/Hydroureteronephrosis(HUN) or renal cyst in site where SWE will be performed (side specific, not patient specific exclusion criterion)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Azienda Ospedale Università di Padova
Padova, PD, 35128
Anna Poretto, MD, +393498156875, anna.poretto@aopd.veneto.it
Filippo Crimì, MD PhD
About this study
Official title: Kidney Shear Wave elasTography for REnal Stiffness in SyStemic Hypertension: a Prospective Pilot Study (K-STRESS Study)
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
Read the detailed description
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.
- Keywords
- shear wave elastoghraphy, eco Doppler ultrasound, arterial hypertension, renal arterial stenosis, chronic kidney disease, primary aldosteronism
- Medical subject headings
- Hypertension, Renal Insufficiency, Chronic, Hyperaldosteronism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| controls | normotensive individuals | |
| essential hypertension | patients with essential hypertension | |
| primary aldosteronism | hypertensive patients with primary aldosteronism | |
| renal arterial stenosis | hypertensive patients with renal arterial stenosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At baseline, single assessment during the renal Doppler ultrasound exam (day 0).
Secondary outcomes (3)
Difference in mean renal cortical stiffness (kPa) between hypertensive patients and healthy controls
Mean of 12 SWE measurements per participant, compared between groups.
Measured: 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.
Measured: 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.
Measured: Baseline (day 0).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2026
- Study start11 Aug 2026
- Primary completion31 Jan 2029 (estimated)
- Study completion31 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Arterial Hypertension, Chronic Kidney DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 240 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera di Padova
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Filippo Crimì, Azienda Ospedaliera di Padova
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07914075
- Sponsor's protocol ID
- 6669/AO/26
- Acronym
- K-STRESS
- Status last verified
- Oct 2026
- First submitted
- 20 Oct 2026
- Last updated
- 3 Nov 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Kidney Disease: Improving Global Outcomes (KDIGO) CKD Work Group. KDIGO 2024 Clinical Practice Guideline for the Evaluation and Management of Chronic Kidney Disease. Kidney Int. 2024 Apr;105(4S):S117-S314. doi: 10.1016/j.kint.2023.10.018. No abstract available.
PubMed 38490803Liu X, Li N, Xu T, Sun F, Li R, Gao Q, Chen L, Wen C. Effect of renal perfusion and structural heterogeneity on shear wave elastography of the kidney: an in vivo and ex vivo study. BMC Nephrol. 2017 Aug 8;18(1):265. doi: 10.1186/s12882-017-0679-2.
PubMed 28789641Nakano M, Kuromatsu R, Kawaguchi T. Ultrasonographic Assessment of Tissue Stiffness: Recent Progress in Transient Elastography and Shear Wave Elastography in the Liver and Various Organs. Kurume Med J. 2024 Jul 2;70(1.2):1-10. doi: 10.2739/kurumemedj.MS7012010. Epub 2024 May 17.
PubMed 38763738Herrmann SM, Textor SC. Renovascular Hypertension. Endocrinol Metab Clin North Am. 2019 Dec;48(4):765-778. doi: 10.1016/j.ecl.2019.08.007. Epub 2019 Sep 19.
PubMed 31655775
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Kidney Shear Wave elasTography for REnal Stiffness in SyStemic Hypertension: a Prospective Pilot Study (K-STRESS Study)
- ClinicalTrials.gov ID
- NCT07914075
- Acronym / sponsor ID
- K-STRESS / 6669/AO/26
- Keywords
- shear wave elastoghraphy, eco Doppler ultrasound, arterial hypertension, renal arterial stenosis, chronic kidney disease, primary aldosteronism
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Azienda Ospedaliera di PadovaUniversity, hospital or other
- Study start
- 11 Aug 2026 (actual)
- Primary completion
- 31 Jan 2029 (estimated)
- Study completion
- 31 Jan 2029 (estimated)
- First posted
- 3 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| controls | – | –normotensive individuals |
| essential hypertension | – | –patients with essential hypertension |
| primary aldosteronism | – | –hypertensive patients with primary aldosteronism |
| renal arterial stenosis | – | –hypertensive patients with renal arterial stenosis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- hypertensive patients
Key inclusion criteria (3 listed)
- Adults ≥18 y
- Informed consent signed
- diagnosis of essential or secondary hypertension or willingness to participate as healthy controls
Key exclusion criteria (6 listed)
- Known parenchymal renal disease other than hypertensive nephrosclerosis, including but not limited to glomerulonephritis, polycystic kidney disease, congenital nephropathy, and storage/infiltrative diseases (e.g. amyloidosis, Fabry disease), as classified according to KDIGO 2024 CKD guidelines (the presence of diabetes mellitus, cardiovascular disease, or peripheral artery disease does not constitute an exclusion criterion)
- patients with urinary tract obstruction
- renal transplant recipients
- pregnant women
- BMI >40
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Mean renal cortical stiffness measured by shear wave elastography (SWE), expressed in kilopascals (kPa)
Time frame: At baseline, single assessment during the renal Doppler ultrasound exam (day 0).
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.
3 secondary outcomes
Difference in mean renal cortical stiffness (kPa) between hypertensive patients and healthy controls
Time frame: Baseline (day 0).
Difference in mean renal cortical stiffness (kPa) between hypertensive patients with and without renal artery stenosis
Time frame: Baseline (day 0).
Difference in mean renal cortical stiffness (kPa) between hypertensive patients with and without primary aldosteronism
Time frame: Baseline (day 0).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Background: PubMed 38490803Kidney Disease: Improving Global Outcomes (KDIGO) CKD Work Group. KDIGO 2024 Clinical Practice Guideline for the Evaluation and Management of Chronic Kidney Disease. Kidney Int. 2024 Apr;105(4S):S117-S314. doi: 10.1016/j.kint.2023.10.018. No abstract available.
- Background: PubMed 28789641Liu X, Li N, Xu T, Sun F, Li R, Gao Q, Chen L, Wen C. Effect of renal perfusion and structural heterogeneity on shear wave elastography of the kidney: an in vivo and ex vivo study. BMC Nephrol. 2017 Aug 8;18(1):265. doi: 10.1186/s12882-017-0679-2.
- Background: PubMed 38763738Nakano M, Kuromatsu R, Kawaguchi T. Ultrasonographic Assessment of Tissue Stiffness: Recent Progress in Transient Elastography and Shear Wave Elastography in the Liver and Various Organs. Kurume Med J. 2024 Jul 2;70(1.2):1-10. doi: 10.2739/kurumemedj.MS7012010. Epub 2024 May 17.
- Background: PubMed 31655775Herrmann SM, Textor SC. Renovascular Hypertension. Endocrinol Metab Clin North Am. 2019 Dec;48(4):765-778. doi: 10.1016/j.ecl.2019.08.007. Epub 2019 Sep 19.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arterial Hypertension, Chronic Kidney Disease and Primary Aldosteronism, run by Azienda Ospedaliera di Padova at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean renal cortical stiffness measured by shear wave elastography (SWE), expressed in kilopascals (kPa) (time frame: At baseline, single assessment during the renal Doppler ultrasound exam (day 0).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07914075, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.