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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-OMON31888
Enrollment
30
Registered
2008-05-13
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

Academisch Medisch Centrum
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, use of calcium antagonists en beta-blockers, 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)