NCT03373500

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2017

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 11, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 29, 2017

Completed
15 days until next milestone

First Posted

Study publicly available on registry

December 14, 2017

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2019

Completed
Last Updated

February 8, 2019

Status Verified

February 1, 2019

Enrollment Period

1.6 years

First QC Date

November 29, 2017

Last Update Submit

February 7, 2019

Conditions

Blood PressureHypertensionKidney Transplant; ComplicationsDietary Modification

Outcome Measures

Primary Outcomes (1)

  • Office systolic and diastolic BP readings

    Systoli and diastolic BP measurements in mmHg

    9 months

Secondary Outcomes (5)

  • Ambulatory BP monitoring

    9 months

  • Endothelial function, measured by digital pulse wave analysis (DVP)

    9 months

  • Arterial stiffness, measured by digital pulse wave analysis (DVP)

    9 months

  • Proteinuria

    9 months

  • Biomarkers of fibrosis

    9 months

Study Arms (2)

Low Salt Diet

EXPERIMENTAL

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

Standard Treatment

NO INTERVENTION

Patients will be instructed to continue with their usual diet, therefore no advice will be given about salt reduction.

Interventions

Dietary salt reductionOTHER

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).

Low Salt Diet

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Epsom and St Helier University Hospitals NHS Trust

Carshalton, Surrey, SM5 1AA, United Kingdom

RECRUITING

Related Publications (1)

  • McMahon EJ, Campbell KL, Bauer JD, Mudge DW, Kelly JT. Altered dietary salt intake for people with chronic kidney disease. Cochrane Database Syst Rev. 2021 Jun 24;6(6):CD010070. doi: 10.1002/14651858.CD010070.pub3.

    PMID: 34164803DERIVED

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Pauline Swift, MBBS

    Epsom and St Helier University Hospitals NHS Trust

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Louise Ross, MBBS

CONTACT

0208 2962250louise.ross9@nhs.net

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Single centre, randomised controlled parallel study.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 29, 2017

First Posted

December 14, 2017

Study Start

October 11, 2017

Primary Completion

June 1, 2019

Study Completion

June 1, 2019

Last Updated

February 8, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)