To evaluate the anti-inflammatory effects of 3 months statin therapy on vessel wall inflammation by means of FDG PET/CT in patients with CKD.
ID
Bron
Verkorte titel
Aandoening
chronic kidney disease stages 3 and 4, defined by a eGFR of 15-60 ml min
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
To evaluate the anti-inflammatory effects of 3 months statin therapy on vessel wall inflammation by means of FDG PET/CT in patients with CKD.
Achtergrond van het onderzoek
This is a single centre intervention study. Our present study will consist of 17 patients with chronic kidney disease stages 3 and 4, defined by a eGFR of 15-60 ml min-1. The primary endpoint is the change in 18F-FDG target-to-background ratio (TBR) following 12 weeks of Atorvastatin 40 mg once daily.
Doel van het onderzoek
To evaluate the anti-inflammatory effects of 3 months statin therapy on vessel wall inflammation by means of FDG PET/CT in patients with CKD.
Onderzoeksopzet
3 months intevention
Onderzoeksproduct en/of interventie
Statin therapy will consist of a once daily dosis of 40 mg Atorvastatine for 3 months
Algemeen / deelnemers
Wetenschappers
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. Aged 50 years or older
2. CKD stages 3 and 4 (eGFR: 15-60 ml/min per 1.73m2)
3. Not receiving lipid lowering therapy
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. Malignant diseases or any clinically significant medical condition that could interfere with the conduct of the study in the opinion of the investigator.
2. Standard contra-indications to 18F-FDG PET, and CT based on physicians experience and current practices
3. Inability or unwillingness to comply with the protocol requirements, or deemed by investigator to be unfit for the study.
4. Planned radiation exposure in the next year due to participation in a research project with radiation exposure or for clinical reasons.
5. Clinical signs of acute infection and/or CRP>10
6. History of MI/Stroke or known coronary artery disease
7. Already receiving lipid lowering treatment
8. Treatment with dialysis or renal transplantation
9. Treatment with CYP3A4 inhibitors
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL6717 |
| NTR-old | NTR6896 |
| Ander register | METC AMC : 2016_093 |