Polycystic Kidney, Autosomal DominantNCT04023214
The Role of Endothelial Dysfunction in Adult Polycystic Kidney Disease
An observational study of Polycystic Kidney, Autosomal Dominant, run by Sheffield Teaching Hospitals NHS Foundation Trust.
Trial summary
This pilot study will compare endothelial function in patients with ADPKD with matched healthy volunteers and normotensive chronic kidney disease stage 1 \& 2 patients. Patients will undergo a single assessment of endothelial function and measurement of plasma and urine levels of biomarkers of endothelial function. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Polycystic Kidney, Autosomal Dominant
- What is being tested?
- Peripheral (digital) arterial tonometry
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 25 Jul 2011to 31 Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Normotensive ADPKD patients with well preserved GFR (>60ml/min) ie those with Stage 1 or 2 Chronic Kidney Disease recruited from a specialist PKD clinic. Healthy controls will be recruited matched to age, sex, body mass index (BMI) and eGFR of the ADPKD patients.
Who may be able to join
- Age >18yrs, <50yrs
- Able to understand spoken/written English sufficiently to give informed consent and to take part in clinical assessment
- Clinical diagnosis of ADPKD
- eGFR >60ml/min/1.73m2
Who cannot join
- No history of cardiovascular disease or hypertension
- Not diabetic
- Not smoking
- Not breastfeeding
- Not pregnant
- Not taking any regular medication (except oral contraceptives)
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- No musculoskeletal conditions contraindicating inflation of a blood pressure cuff to suprasystolic pressures around the forearm (as part of EndoPAT measurements)
- Not morbidly obese: BMI<35 (May contribute to endothelial dysfunction)
- eGFR <60ml/min/1.73m2
About this study
Official title: Endothelial Dysfunction in Autosomal Dominant Polycystic Kidney Disease
This pilot study will compare endothelial function in patients with ADPKD with matched healthy volunteers and normotensive chronic kidney disease stage 1 \& 2 patients. Patients will undergo a single assessment of endothelial function and measurement of plasma and urine levels of biomarkers of endothelial function.
Read the detailed description
Following recruitment we will record the following baseline demographics; age, gender, smoking status, body mass index, medical history.
Participants will undergo a noninvasive vascular assessment, venepuncture and will provide a urine sample.This will be done during a single visit to the CRF.
Noninvasive vascular assessment will consist of:
- Peripheral Arterial Tonometry This will be measured using the EndoPAT system (Itamar Medical) Endothelial shear stress flow stimulus will be provided by inflation of a blood pressure cuff around the upper non-dominant arm to suprasystolic pressure (but <300mmHg) for 5 minutes. Following release of the cuff the resulting digital microcirculation vasodilatory response to ischaemic hyperaemia, quantified as the pulse wave amplitude, will be monitored over 5 minutes. The peak pulse wave amplitude measured at 90-150s post cuff deflation relative to baseline will be indexed to the changes in the opposite arm to give the reactive hyperaemia index. This measure of endothelial function constitutes the outcome measure.
- Blood Pressure Assessment Brachial artery blood pressure will be measured in the left arm in the supine position using an automated device (Dinamap) and in accordance with the clinical research facility SOP.
- Blood samples and urine samples
Samples for plasma will be centrifuged and stored at -80C. Biochemical analysis will be performed by the laboratory of the STH NHS Trust for standard tests and by validated assays for non-routine markers (as detailed below) in the Academic Nephrology Unit.
Participants will be asked to collect a 24h urine sample from the day before the study visit and to provide a spot urine sample on the day. This will be analysed at the laboratory of the STH NHS Trust.
Biochemical Analysis
Serum samples will be analyzed for Full blood count, Urea, Electrolytes, Glucose, Insulin, Lipid Profile, Homocysteine, (Hs) CRP and Creatinine Levels.
Serum and plasma will also be stored for future analysis of relevant biomarkers of endothelial function or nitric oxide metabolism as indicated by preliminary results.
Urine samples will be analysed initially for protein creatinine ratio (PCR). The rest will be frozen for future analysis of urinary biomarkers of endothelial function or nitric oxide metabolism.
- Conditions
- Polycystic Kidney, Autosomal Dominant
- Being tested
- Peripheral (digital) arterial tonometry
- Medical subject headings
- Polycystic Kidney, Autosomal Dominant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peripheral (digital) arterial tonometryDiagnostic test
This will be measured using the EndoPAT system (Itamar Medical)
| Study group | Role | What they receive |
|---|---|---|
| ADPKD | ADPKD patients Receives: Diagnostic Test: Peripheral (digital) arterial tonometry | |
| Controls | Healthy volunteers Receives: Diagnostic Test: Peripheral (digital) arterial tonometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reactive hyperemia index (RHI)
EndoPAT values (Endoscore)
Measured: Baseline
Secondary outcomes (2)
Systolic and diastolic Blood pressure
mm Hg
Measured: Baseline
Proteinuria
Protein creatinine ratio
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2019
- Study start25 Jul 2011
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polycystic Kidney, Autosomal DominantStudies 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- University of Sheffield
- Responsible party
- Sponsor
- Investigators
- Albert Ong, Principal investigator, STHTimothy Chico, Study director, STH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04023214
- Sponsor's protocol ID
- STH15983
- Status last verified
- Jul 2019
- First submitted
- 15 Jul 2019
- Last updated
- 17 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endothelial Dysfunction in Autosomal Dominant Polycystic Kidney Disease
- ClinicalTrials.gov ID
- NCT04023214
- Acronym / sponsor ID
- STH15983
- Conditions
- Polycystic Kidney, Autosomal Dominant
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation TrustUniversity, hospital or other
- Collaborators
- University of Sheffield
- Study start
- 25 Jul 2011 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 17 Jul 2019 (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.
This pilot study will compare endothelial function in patients with ADPKD with matched healthy volunteers and normotensive chronic kidney disease stage 1 \& 2 patients. Patients will undergo a single assessment of endothelial function and measurement of plasma and urine levels of biomarkers of endothelial function.
Detailed description
Following recruitment we will record the following baseline demographics; age, gender, smoking status, body mass index, medical history.
Participants will undergo a noninvasive vascular assessment, venepuncture and will provide a urine sample.This will be done during a single visit to the CRF.
Noninvasive vascular assessment will consist of:
- Peripheral Arterial Tonometry This will be measured using the EndoPAT system (Itamar Medical) Endothelial shear stress flow stimulus will be provided by inflation of a blood pressure cuff around the upper non-dominant arm to suprasystolic pressure (but <300mmHg) for 5 minutes. Following release of the cuff the resulting digital microcirculation vasodilatory response to ischaemic hyperaemia, quantified as the pulse wave amplitude, will be monitored over 5 minutes. The peak pulse wave amplitude measured at 90-150s post cuff deflation relative to baseline will be indexed to the changes in the opposite arm to give the reactive hyperaemia index. This measure of endothelial function constitutes the outcome measure.
- Blood Pressure Assessment Brachial artery blood pressure will be measured in the left arm in the supine position using an automated device (Dinamap) and in accordance with the clinical research facility SOP.
- Blood samples and urine samples
Samples for plasma will be centrifuged and stored at -80C. Biochemical analysis will be performed by the laboratory of the STH NHS Trust for standard tests and by validated assays for non-routine markers (as detailed below) in the Academic Nephrology Unit.
Participants will be asked to collect a 24h urine sample from the day before the study visit and to provide a spot urine sample on the day. This will be analysed at the laboratory of the STH NHS Trust.
Biochemical Analysis
Serum samples will be analyzed for Full blood count, Urea, Electrolytes, Glucose, Insulin, Lipid Profile, Homocysteine, (Hs) CRP and Creatinine Levels.
Serum and plasma will also be stored for future analysis of relevant biomarkers of endothelial function or nitric oxide metabolism as indicated by preliminary results.
Urine samples will be analysed initially for protein creatinine ratio (PCR). The rest will be frozen for future analysis of urinary biomarkers of endothelial function or nitric oxide metabolism.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ADPKD | – | Diagnostic Test: Peripheral (digital) arterial tonometryADPKD patients |
| Controls | – | Diagnostic Test: Peripheral (digital) arterial tonometryHealthy volunteers |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Normotensive ADPKD patients with well preserved GFR (>60ml/min) ie those with Stage 1 or 2 Chronic Kidney Disease recruited from a specialist PKD clinic. Healthy controls will be recruited matched to age, sex, body mass index (BMI) and eGFR of the ADPKD patients.
Key inclusion criteria (4 listed)
- Age >18yrs, <50yrs
- Able to understand spoken/written English sufficiently to give informed consent and to take part in clinical assessment
- Clinical diagnosis of ADPKD
- eGFR >60ml/min/1.73m2
Key exclusion criteria (9 listed)
- No history of cardiovascular disease or hypertension
- Not diabetic
- Not smoking
- Not breastfeeding
- Not pregnant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peripheral (digital) arterial tonometryThis will be measured using the EndoPAT system (Itamar Medical) | Diagnostic test | ADPKD, Controls |
Primary outcome
Reactive hyperemia index (RHI)
Time frame: Baseline
EndoPAT values (Endoscore)
2 secondary outcomes
Systolic and diastolic Blood pressure
Time frame: Baseline
Proteinuria
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2019.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Albert Ong principal investigator
STH
Timothy Chico study director
STH
Questions about this trial
What is this clinical trial studying?
An observational study of Polycystic Kidney, Autosomal Dominant, run by Sheffield Teaching Hospitals NHS Foundation Trust.
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 4 inclusion and 9 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: finished, as of the sponsor's last update on 17 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reactive hyperemia index (RHI) (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Jul 2019.