Clinical trial NCT03082339: Cortisone and QTc-Interval
Official title: Influence of Cortisone on QTc-interval
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: QTc-interval
Lead sponsor: Asklepios Neurological Clinic Bad Salzhausen
Sponsor class: OTHER
Collaborators: name: University of Giessen
First posted: 2017-03-17
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with inflammatory neurological (especially multiple sclerosis) and pulmological (after LTX) diseases, who underwent therapy with cortisone (\>= 40 mg/d).

Brief summary: Scientific and clinical data report about shortening of QTc-interval in patients treated with cortisone. Peal et al. analyzed chemical suppression of long QT syndrome (Type 2) in an in vivo zebrafish model. Their study revealed that flurandrenolide reproducibly suppressed the long QT phenotype via the glucocorticoid signaling pathway. In contrast to treatment with dexamethasone and testosterone, treatment with pure mineralocorticoid deoxycorticosterone acetate did not suppress long QT phenotype. Knockdown of the glucocorticoid receptor or, conversely, of the androgen receptor showed that flurandrenolide acting through the glucocorticoid receptor shortens ventricular action potentials. The mechanism is distinct from trafficking rescue of the defective zebrafish-ERG channel. The authors discuss that a drug normalizing repolarization would be a novel therapeutic tool in long QT syndrome and conclude that glucocorticoids could be expected to aid in the acute management of patients with long QT syndrome, e.g. in episodes of arrhythmic storm. In addition, corticoid induced normalization of the QT interval is reported in a patient with drug-induced prolongation of the QTc interval. Brostoff et al. report on a patient suffering from mucocutaneous leishmaniasis treated with sodium stibogluconate. During therapy, the QTc interval prolonged and returned to normal within 4 days after starting glucocorticoid therapy with prednisolone 20 mg twice daily.

Interrogation of the study:

* shortens cortisone the QTc-interval?
* how long is the interval until shortening of QTc-interval?
* is the effect prolonged?
* is the effect dose dependend?


Eligibility criteria: Inclusion Criteria:

* patients who underwent therapy with cortisone (\>=40mg/d)

Exclusion Criteria:

* patients with elevated intracranial pressure
* myocardial infarction within the last 6 months
* untreated stenosis of the coronary arteries
* right bundle branch block
* autoimmune disease

Primary outcomes:
measure: Duration of QTc-interval
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Gießen
country: Germany
facility: University Giessen
city: Nidda
country: Germany
facility: Neurologische Klinik Bad Salzhausen
Study officials:
References:
citation: Brostoff JM, Lockwood DN. Glucocorticoids as a novel approach to the treatment of disabling side effects of sodium stibogluconate. J Clin Pharm Ther. 2012 Feb;37(1):122-3. doi: 10.1111/j.1365-2710.2011.01259.x. Epub 2011 Apr 4.
citation: Peal DS, Mills RW, Lynch SN, Mosley JM, Lim E, Ellinor PT, January CT, Peterson RT, Milan DJ. Novel chemical suppressors of long QT syndrome identified by an in vivo functional screen. Circulation. 2011 Jan 4;123(1):23-30. doi: 10.1161/CIRCULATIONAHA.110.003731. Epub 2010 Nov 15.