Diastolic Dysfunction, Microcirculation Disturbance, Sympathetic Activation and Inflammation in Moderate Kidney Failure and in Diabetic Nephropathy: Disease Modification With Vitamin-D Receptor Activation. A Double-blind, Placebo-controlled, Randomised Trial - the SOLID Trial
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 36
- Locations
- 1
- Primary Endpoint
- A significant reduction in muscle sympathetic nerve activity (MSNA) measured by means of microneurography.
Study Overview
Brief Summary
To investigate whether treatment with a vitamin-D receptor activator is able to improve important markers of cardiovascular risk.
Detailed Description
Main question:
May 12 weeks of VDRA treatment reduce the pathological sympathetic overactivation associated with moderate kidney disease?
Secondary questions aim to thrown light on how VDRAs can reduce albuminuria and CRP, i.e. does VDRA treatment improve (prespecified statistical analyses):
A) diastolic dysfunction? B) capillary microcirculation, and whether ameliorated disturbances relate to improved diastolic dysfunction? C) endothelial dysfunction and arterial stiffness? D) inflammatory activation? E) platelet function and haemostasis? F) levels of antibacterial peptides? G) levels of IGFBP-1 and adiponectin?
Overall design The study is designed as a double-blind, randomised, placebo-controlled trial involving two groups (n=72) of patients: 1) chronic kidney failure (CKD, eGFR 15-59 mL/m2) and 2) chronic kidney failure and concomitant diabetes mellitus (CKD+DM).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 20 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •eGFR 15-59 ml/m2
Exclusion Criteria
- •Current vitamin D treatment
Arms & Interventions
Paricalcitol 2 microgram/d
Intervention: Zemplar (Drug)
Paricalcitol 1 microgram/d
Intervention: Zemplar (Drug)
Placebo
Intervention: Zemplar (Drug)
Outcomes
Primary Outcomes
A significant reduction in muscle sympathetic nerve activity (MSNA) measured by means of microneurography.
Time Frame: Measured after 12 weeks treatment.
Sympathetic activation is closely related to severity and progression of cardiovascular diseases, and renovascular dysfunction. We will directly measure sympathetic activation using microneurography (muscle sympathetic nerve activity; MSNA), expressed as bursts/minute and bursts/100 RR-interval. As this is a physiological study, the primary outcome will constitute a significant reduction in MSNA.
Secondary Outcomes
- Microcirculatory function measured by laser doppler methods.(Measured after 12 weeks treatment.)
Investigators
Jonas Spaak
MD, PhD
Danderyd Hospital