Cortisone and QTc-Interval

Completed

• Conditions: QTc-interval
• Interventions: Other: Cortisone

• Registration Number: NCT03082339
• Lead Sponsor: Asklepios Neurological Clinic Bad Salzhausen

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?

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-03-12
• Study First Submitted QC: 2017-03-16
• Study First Posted: 2017-03-17
• Study Start: 2017-04-01
• Primary Completion: 2020-04-25
• Study Completion: 2020-04-25
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-01
• Last Update Posted: 2020-05-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 105

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Neurology	Cortisone	Patients with inflammatory disease, especially multiple sclerosis, who underwent therapy with cortisone (\>=40mg/d)
Pulmonology	Cortisone	Patients after LTX (under medication possible prologing QTc-interval), who underwent therapy with cortisone (\>=40mg/d)

Primary Outcome Measures

Name	Time	Method
Duration of QTc-interval	1 week	daily ECG controls and measuring QTc-interval

Trial Locations

Locations (2)

University Giessen; 🇩🇪 Gießen, Germany

Neurologische Klinik Bad Salzhausen; 🇩🇪 Nidda, Germany