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Effects of dietary sodium restriction on blood pressure in renal transplant recipients: an intervention study

Effects of dietary sodium restriction on blood pressure in renal transplant recipients: an intervention study - SORRT

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON39389
Enrollment
42
Registered
2011-08-17
Start date
2012-01-06
Completion date
Unknown
Last updated
2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

hypertensie high blood pressure hypertension

Interventions

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

Sponsors

Universitair Medisch Centrum Groningen
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria: - Blood pressure 160/95 mmHg - Complaints or signs of orthostatic hypotension - Creatinine clearance 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 outcomes

Primary

MeasureTime frame
- Blood pressure -and use of antihypertensive medication

Secondary

MeasureTime frame
- 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)

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)