The Role of Endothelial Dysfunction in Adult Polycystic Kidney Disease

NCT04023214 | Completed

• 1 other identifier: STH15983
• Study Type: observational
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Polycystic Kidney, Autosomal Dominant

Outcome Measures

Primary Outcomes (1)

• Reactive hyperemia index (RHI)

  EndoPAT values (Endoscore)

  Baseline

Secondary Outcomes (2)

• Systolic and diastolic Blood pressure

  Baseline

• Proteinuria

  Baseline

Study Arms (2)

ADPKD

ADPKD patients

Diagnostic Test: Peripheral (digital) arterial tonometry

Controls

Healthy volunteers

Diagnostic Test: Peripheral (digital) arterial tonometry

Interventions

Peripheral (digital) arterial tonometry DIAGNOSTIC_TEST

This will be measured using the EndoPAT system (Itamar Medical)

ADPKD; Controls

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• No history of cardiovascular disease or hypertension
• Not diabetic
• Not smoking
• Not breastfeeding
• Not pregnant
• Not taking any regular medication (except oral contraceptives)
• 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

Sponsors & Collaborators

• Sheffield Teaching Hospitals NHS Foundation Trust: lead
• University of Sheffield: collaborator

MeSH Terms

Conditions

Polycystic Kidney, Autosomal Dominant

Condition Hierarchy (Ancestors)

Polycystic Kidney Diseases; Kidney Diseases, Cystic; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Ciliopathies; Genetic Diseases, Inborn

Study Officials

• Albert Ong

  STH

  PRINCIPAL INVESTIGATOR

• Timothy Chico

  STH

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2019
• First Posted: July 17, 2019
• Study Start: July 25, 2011
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2018
• Last Updated: July 17, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share