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The effectiveness of intensive treatment on sympathetic hyperactivity. A randomized, cross-over trial in patients with chronic kidney disease and hypertension

The effectiveness of intensive treatment on sympathetic hyperactivity. A randomized, cross-over trial in patients with chronic kidney disease and hypertension - The effect of intensive treatment on sympathetic hyperactivity

Status
Unknown
Phases
Phase 3
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON31295
Enrollment
30
Registered
2007-11-12
Start date
Unknown
Completion date
Unknown
Last updated
2024-05-13

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

Conditions

Hypertensie chronic kidney diseases Chronic renal diseases

Interventions

Participants of this study receive 160mg/day valsartan for 8 weeks. After the first 8 weeks the first MSNA measurement will be done. Then patients will be randomized in group 320mg/day and group 640

Sponsors

Universitair Medisch Centrum Utrecht
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Patients with stable chronic kidney disease and hypertension: i.e. using antihypertensive drugs and/or blood pressure >145/90mmHg when off medication.

Exclusion criteria

Exclusion criteria: Patients with diabetes mellitus and patients on renal replacement therapy are excluded. In addition, patients with severe liver insufficiency, biliary cirrhosis and cholestasis, pregnant patients and patients in lactation are excluded as Valsartan is contra-indicated for these patients.

Design outcomes

Primary

MeasureTime frame
Primary endpoint/outcome - Primary endpoint: the effect of increasing dosage of valsartan on MSNA - Primary expected outcome: further decrease in MSNA as compared to the MSNA during standard dosage—

Secondary

MeasureTime frame
Secondary endpoint/outcome 1. Secondary endpoint: assessment of normalization of MSNA after application of higher than usual dosage of valsartan - Secondary expected outcome: normalization of MSNA after application of higher than usual dosage of valsartan 2. Effect of higher than usual dosage of valsartan on blood pressure - Secondary outcome: higher than usual dosage of valsartan will not have a further effect on blood pressure—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)