Primary Objective: •To investigate the effect of dietary sodium restriction on blood pressure and use of antihypertensive medication in renal transplant recipients.Secondary Objective(s): •To investigate the effect of dietary sodium restriction on…
ID
Source
Brief title
Condition
- Other condition
- Cardiac disorders, signs and symptoms NEC
- Renal disorders (excl nephropathies)
Synonym
Health condition
hypertensie
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- Blood pressure -and use of antihypertensive medication
Secondary outcome
- Plasma NT-proBNP
- Relative changes between low and liberal sodium intake in stroke volume,
cardiac output and SVR and baroreflex sensitivity as measured by NexfinTM (in
the AMC) both supine and after 5 minutes standing
- Urinary protein and albumin excretion
- Urinary excretion of tubulo-interstitial damage markers (e.g. KIM-1, NAG,
NGAL, AAP, TGFB, CTFG)
Background summary
Hypertension is present in more than 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.
Study objective
Primary Objective:
•To investigate the effect of dietary sodium restriction on blood pressure and
use of antihypertensive medication in renal transplant recipients.
Secondary Objective(s):
•To investigate the effect of dietary sodium restriction on extracellular
volume as estimated from volume parameters such as NT-proBNP and systemic
haemodynamics (non-invasive estimations of stroke volume, cardiac output and
systemic vascular resistance)
•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.
Study design
The study is designed as a 12 week multicenter randomized crossover clinical
trial with two parallel groups.
Intervention
Patients will be symmetrically randomized to a liberal sodium diet aimed at 150
mmol (9 grams) daily (control group) or a low sodium diet aimed at 50 mmol (3
grams) daily (intervention group) for 6 weeks. After 6 weeks groups will
cross-over from intervention group to control group and vice versa and follow
the other diet for 6 weeks.
Study burden and risks
Patients are asked to visit the outpatient clinic 4 times. Prior to the last 3
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.
Hanzeplein 1
Groningen 9700 RB
NL
Hanzeplein 1
Groningen 9700 RB
NL
Listed location countries
Age
Inclusion criteria
- Written informed consent
- Male and female renal transplant recipients
- Transplantation performed in the UMCG/AMC
- Patients that are one year after transplantation or beyond
- 18 years or older
- Stable renal function at study entry
- Use of RAAS-blockade: either an angiotensin-converting enzyme inhibitor (ACEi) or an angiotensin receptor blocker (ARB)
Exclusion criteria
- Blood pressure < 120/80 mmHg
- Blood pressure > 160/95 mmHg
- Complaints or signs of orthostatic hypotension
- Creatinine clearance < 30 ml/min/1.73m2
- Proteinuria > 1.5 g/24h
- Severe general diseases or mental disorders making the participation in the study impossible
- Pregnancy
- Being on a cyclosporine withdrawal regimen
- Rejection of the allograft for which a switch in immunosuppressive medication is necessary
- Drug abuse
- No sufficient knowledge of the Dutch language to participate in the study
- Participation in an other intervention study during or within a month prior to this study
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| Other | Nederlands Trial Register TC3951 |
| CCMO | NL36854.042.11 |