Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03373500
Recruitment Status : Recruiting
First Posted : December 14, 2017
Last Update Posted : February 8, 2019
Sponsor:
Information provided by (Responsible Party):
Epsom and St Helier University Hospitals NHS Trust

Brief Summary:

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

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Single centre, randomised controlled parallel study.
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. Office systolic and diastolic BP readings [ Time Frame: 9 months ]
    Systoli and diastolic BP measurements in mmHg


Secondary Outcome Measures :
  1. Ambulatory BP monitoring [ Time Frame: 9 months ]
    Total 24 hour average systolic and diastolic BP measurements in mmHg

  2. 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)

  3. 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.

  4. Proteinuria [ Time Frame: 9 months ]
    Urinary protein creatinine ratio in g/mol and albumin creatinine ratio in g/mol

  5. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients who have received a kidney transplant ≥ 6 months previously who have a BP >130 mm Hg systolic and/or >80 mm Hg diastolic, or are receiving treatment for hypertension.

Exclusion Criteria:

  • BP < 120/80 on blood pressure treatment
  • BP >160/100
  • Variation in Creatinine >20% over preceding 2 months
  • Secondary hypertension due to a cause other than CKD
  • Heart failure (LVEF <30% or NYHA class II - IV)
  • Myocardial Infarction within 6 months
  • Stroke within 6 months
  • Current diagnosis of cancer
  • Liver disease
  • Bilateral arterio-venous fistulae
  • Evidence of significant active infection
  • Females who are pregnant or breastfeeding
  • Hyponatremia (Na <130mmol/L) or Hypernatremia (Na >150mmol/L)
  • Histologically confirmed episode of rejection within 6 months
  • Steroids dose change in preceding 2 months
  • Patients who are not able to give full informed consent
  • Initial 24hr urinary sodium <80mmol/24hrs

Information from the National Library of Medicine

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


Contacts
Layout table for location contacts
Contact: Louise Ross, MBBS 0208 2962250 louise.ross9@nhs.net

Locations
Layout table for location information
United Kingdom
Epsom and St Helier University Hospitals NHS Trust Recruiting
Carshalton, Surrey, United Kingdom, SM5 1AA
Contact: Yvonne Reilly    020 8296 4699    yvonnereilly@nhs.net   
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         
Sponsors and Collaborators
Epsom and St Helier University Hospitals NHS Trust
Investigators
Layout table for investigator information
Principal Investigator: Pauline Swift, MBBS Epsom and St Helier University Hospitals NHS Trust
Layout table for additonal information
Responsible Party: Epsom and St Helier University Hospitals NHS Trust
ClinicalTrials.gov Identifier: NCT03373500    
Other Study ID Numbers: 002S/2016/REN
First Posted: December 14, 2017    Key Record Dates
Last Update Posted: February 8, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Hypertension
Vascular Diseases
Cardiovascular Diseases