ECE2020 Audio ePoster Presentations Adrenal and Cardiovascular Endocrinology (121 abstracts)
1Leiden University Medical Center (LUMC), Endocrinology, Leiden, Netherlands; 2Sahlgrenska University Hospital, Endocrinology, Göteborg, Sweden; 3Hospital de la Santa Creu i Sant Pau, Endocrinology, Barcelona, Spain; 4Leiden University Medical Center (LUMC), Psychiatry, Leiden, Netherlands; 5Sahlgrenska Academy, Clinical Neuroscience and Rehabilitation, Göteborg, Sweden; 6Hospital de la Santa Creu i Sant Pau, Radiolagical Imaging, Barcelona, Spain
Background: Patients with Cushing’s Syndrome (CS) suffer from a variety of neuropsychiatric and cognitive problems. Following remission, some, but not all of these symptoms resolve. Recent cross-sectional studies in patients with CS show persistent structural and functional brain abnormalities. However, longitudinal studies using magnetic resonance imaging, and a detailed neurocognitive assessment, performed before and after treatment, are not available.
Trial objective: To investigate the extent and time-course of restoration of physical and neurocognitive symptoms, as well as functional and structural brain abnormalities in patients with CS.
Methods: The IQFACE-CS study is an investigator-initiated, multicentre, international, prospective observational cohort study (ClinTrial.gov:NCT03211624).
Thirty-six patients with active CS and 36 age-, sex-, and education-matched controls will be included. Neurocognitive tests, general and disease specific QoL questionnaires, and functional task-based and structural MRI are performed before treatment and 1 and 2 years after treatment. Currently, 25 patients and 4 controls have been included. Twenty patients were female, mean age at inclusion was 50 years. Ten patients had adrenal Cushing, while 14 had pituitary source. At baseline, mean 24 hour UFC was 723 nmol, mean midnight salivary cortisol was 16.0 nmol/L, and serum cortisol after 1-mg dexamethasone suppression test was 375 nmol/l. Fifteen patients received presurgical treatment with ketoconazole, while 5 patients used metyrapone. Elevated liver enzymes were observed in 5 patients. Mean preoperative 24-hour UFC decreased to 167 nmol. Remission was achieved in 14/17 (82%) operated patients, recurrence was observed in 1 patient during the study period. Four patients have completed the trial.
The study is financially supported by an unrestricted grant fromHRA Pharma.
Conclusion: This study discusses the rationale, design, and progress of the IQFACE-CS study. Inclusion is still ongoing, and final results are expected at the end of 2022.