Effect of Dietary Salt Reduction on Blood Pressure in Kidney Transplant Recipients
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03373500|
Recruitment Status : Unknown
Verified February 2019 by Epsom and St Helier University Hospitals NHS Trust.
Recruitment status was: Recruiting
First Posted : December 14, 2017
Last Update Posted : February 8, 2019
Cardiovascular morbidity and mortality is increased in kidney transplant patients. High blood pressure (BP) contributes significantly to this risk and is also associated with shortened allograft survival. Salt reduction lowers BP in the general population and there is emerging data that salt reduction also effectively lowers BP in chronic kidney disease (CKD). Kidney transplant patients, by definition have CKD, but they differ fundamentally from the general CKD population in that they are on medications which can predispose to high blood pressure, their kidneys are denervated, and they often have reasonable excretory kidney function.
The proposed study will be an eight-week randomised, controlled trial assessing the effect of intensive dietary salt advice on cardiovascular risk factors in kidney transplant patients. The primary outcome is office BP readings, with the effect on 24-hour ambulatory blood pressure, proteinuria, arterial stiffness and endothelial function being studied as secondary outcomes.
|Condition or disease||Intervention/treatment||Phase|
|Blood Pressure Hypertension Kidney Transplant; Complications Dietary Modification||Other: Dietary salt reduction||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||66 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Single centre, randomised controlled parallel study.|
|Masking:||None (Open Label)|
|Official Title:||A Randomised Controlled Trial of the Effect of Dietary Salt Reduction on Blood Pressure and Other Cardiovascular Parameters in Kidney Transplant Recipients|
|Actual Study Start Date :||October 11, 2017|
|Estimated Primary Completion Date :||June 1, 2019|
|Estimated Study Completion Date :||June 1, 2019|
Experimental: Low Salt Diet
Dietary salt reduction: Patients will be given intensive dietary advice to achieve a low salt diet, targeting a dietary salt intake of less than 5g per day (80 mmol/day).
Other: Dietary salt reduction
Patients will be given intensive dietary advice to achieve a low salt diet, targeting a dietary salt intake of less than 5g per day (80 mmol/day).
No Intervention: Standard Treatment
Patients will be instructed to continue with their usual diet, therefore no advice will be given about salt reduction.
- Office systolic and diastolic BP readings [ Time Frame: 9 months ]Systoli and diastolic BP measurements in mmHg
- Ambulatory BP monitoring [ Time Frame: 9 months ]Total 24 hour average systolic and diastolic BP measurements in mmHg
- Endothelial function, measured by digital pulse wave analysis (DVP) [ Time Frame: 9 months ]Endothelial dependent function will be calculated as the difference between the mean measurements of the baseline reflective index (RI) measurements and the RI following Salbutamol inhalation and endothelium independent function is calculated as the difference between the mean of the baseline RI measurements and the RI following administration of glyceroltrinitrate (GTN)
- Arterial stiffness, measured by digital pulse wave analysis (DVP) [ Time Frame: 9 months ]The systolic peak and inflection point are obtained by analysing the first derivative of DVP waveforms. The time between first systolic peak and the inflection point in the waveforms (∆TDVP) is determined. The DVP-derived stiffness index (SIDVP) is calculated by the following equation: body height /∆TDVP.
- Proteinuria [ Time Frame: 9 months ]Urinary protein creatinine ratio in g/mol and albumin creatinine ratio in g/mol
- Biomarkers of fibrosis [ Time Frame: 9 months ]TGF-β1, 2 & 3 will be measured on a multiplex platform using a Bioplex analyser. CTGF & EDA+Fibronectin levels will be assesed by semi-quantitative Western Blotting, which will identify full length proteins and also biologically relevant fragments and isoforms. EDA+Fibronectin will be compared to total Fibronectin using an adaptation of a commercial ELISA. Levels of CTGF in the plasma will also be measured. These urinary and plasma biomarkers can then be correlated with the 48hr urinary sodium excretion performed at the beginning and end of the study.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03373500
|Contact: Louise Ross, MBBS||0208 firstname.lastname@example.org|
|Epsom and St Helier University Hospitals NHS Trust||Recruiting|
|Carshalton, Surrey, United Kingdom, SM5 1AA|
|Contact: Yvonne Reilly 020 8296 4699 email@example.com|
|Principal Investigator: Pauline Swift, FRCP PhD|
|Sub-Investigator: Louise Ross, MRCP|
|Sub-Investigator: Rebecca Suckling, MRCP PhD|
|Sub-Investigator: Mark Dockrell, PhD|
|Sub-Investigator: Peter Andrews, FRCP MD|
|Principal Investigator:||Pauline Swift, MBBS||Epsom and St Helier University Hospitals NHS Trust|