|- candidate number||14720|
|- NTR Number||NTR3951|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||13-apr-2013|
|- Secondary IDs||2011.131 / NL36854.042.11; METC / CCMO|
|- Public Title||Dietary Sodium Restriction in Renal Transplant Recipients.|
|- Scientific Title||Dietary Sodium Restriction in Renal Transplant Recipients: An intervention study to investigate the effects of dietary sodium restriction on blood pressure.|
|- hypothesis||Reduction in dietary sodium intake decreases blood pressure, extracellular volume and renal damage in renal transplant recipients.|
|- Healt Condition(s) or Problem(s) studied||Renal transplant |
|- Inclusion criteria||1. Written informed consent;|
2. Male and female transplant recipients;
3. Transplantation performed in the University Medical Center Groningen or Academic Medical Center Amsterdam;
4. Patients that are one year after transplantation or beyond;
5. 18 years or older;
6. Stable renal function at study entry;
7. Use of RAAS-blockade: either an angiotensin-converting enzyme inhibitor (ACEi) or an angiotensin receptor blocker (ARB).
|- Exclusion criteria||1. Blood pressure < 120/80 mmHg;|
2. Blood pressure > 160/95 mmHg;
3. Complaints or signs of orthostatic hypotension;
4. Creatinine clearance < 30 ml/min/1.73m2;
5. Proteinuria > 1.5 g/24h;
6. Being on a cyclosporine withdrawal regimen;
7. Rejection of the allograft for which a switch in immunosuppressive medication is necessary;
8. Severe general diseases or mental disorders making the participation in the study impossible;
10. Drug abuse;
11. No sufficient knowledge of the Dutch language to participate in the study;
12. Participation in another intervention study during or within a month prior to this study.
|- mec approval received||yes|
|- multicenter trial||yes|
|- control||Not applicable|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-jan-2012|
|- planned closingdate||1-aug-2014|
|- Target number of participants||42|
|- Interventions||Low dietary sodium intake (~50 mmol/day = 3 grams salt/day) vs liberal dietary sodium intake (~150 mmol/dayg = 9 grams salt/day). This is a crossover design with an intervention period of 6 weeks each.|
|- Primary outcome||1. Blood pressure;|
2. Number of antihypertensives used.
|- Secondary outcome||1. Extracellular volume, as measured by volume marker NT-proBNP;|
2. Renal damage, as measured by urinary protein/albumin excretion, and urinary excretion of tubulointerstitial damage markers.
|- Timepoints||4 timepoints. |
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES|| L.V. Vries, de|
|- CONTACT for SCIENTIFIC QUERIES|| L.V. Vries, de|
|- Sponsor/Initiator ||University Medical Center Groningen (UMCG)|
(Source(s) of Monetary or Material Support)
|University Medical Center Groningen (UMCG)|
|- Brief summary||Rationale: |
Hypertension is present in >70% of renal transplant recipients and a known risk factor for cardiovascular morbidity, cardiovascular mortality, and graft failure. Volume expansion caused by high sodium intake might play an important role in the development and maintenance of hypertension in renal transplant recipients. Although the effects of dietary sodium restriction have been investigated in healthy subjects and patients with chronic kidney disease, this has not yet been studied in RTR.
1. To investigate the effect of dietary sodium restriction on blood pressure in renal transplant recipients.
1. To investigate the effect of dietary sodium restriction on extracellular volume as measured by volume parameters such as NT-proBNP;
2. To investigate the effect of dietary sodium restriction on renal damage as measured by urinary protein and albumin excretion and excretion of tubulointerstitial damage markers.
The study is designed as a 12 week randomized crossover clinical trial with two parallel groups.
The study population will consist of male and female renal transplant recipients who are one year after transplantation or beyond.
Patients will be symmetrically randomized to a liberal sodium diet aimed at 150 mmol (9 grams) daily or a low sodium diet aimed at 50 mmol (3 grams) daily.
Main study parameters/endpoints:
1. Blood pressure and use of antihypertensive medication;
2. Plasma NT-proBNP;
3. Urinary protein and albumin excretion, and urinary excretion of tubulointerstitial damage markers.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
Patients are asked to visit the outpatient clinic 4 times. Prior to these visits patients have to collect 24-hour urine of the previous day and fill in dietary questionnaires the three days prior to their visits. The potential benefit of a low sodium diet may be a reduction of blood pressure, with subsequent reduction of cardiovascular risk and local renal damage. It may furthermore be accompanied by decreased tendency for plasma volume expansion with a reduction in the tendency for development of heart failure. Participation in the study is on a free-will base. Patients will not receive any financial support or priority for treatment of other diseases in the clinic during this study. All costs that subjects need for transportation in order to attend the clinic for the study purpose will be reimbursed completely.
|- Main changes (audit trail)||12-dec-2014: Since January 2014, the trial became a multicenter trial. - AB|
|- RECORD||13-apr-2013 - 12-dec-2014|