Cortisone and QTc-Interval

NCT03082339 | Completed

• 1 other identifier: QTc25416
• Study Type: observational
• Target: 105
• Locations: 1 country
• Sites: 2

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?

Conditions

QTc-interval

Outcome Measures

Primary Outcomes (1)

• Duration of QTc-interval

  daily ECG controls and measuring QTc-interval

  1 week

Study Arms (2)

Neurology

Patients with inflammatory disease, especially multiple sclerosis, who underwent therapy with cortisone (\>=40mg/d)

Other: Cortisone

Pulmonology

Patients after LTX (under medication possible prologing QTc-interval), who underwent therapy with cortisone (\>=40mg/d)

Other: Cortisone

Interventions

Cortisone OTHER

Observation of QTc-interval

Neurology; Pulmonology

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Asklepios Neurological Clinic Bad Salzhausen: lead
• University of Giessen: collaborator

Study Sites (2)

University Giessen

Giessen, 35394, Germany

Location

Neurologische Klinik Bad Salzhausen

Nidda, 63667, Germany

Location

Related Publications (2)

• 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.

  PMID: 21457289 BACKGROUND

• 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.

  PMID: 21098441 BACKGROUND

MeSH Terms

Interventions

Cortisone

Intervention Hierarchy (Ancestors)

Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; 17-Hydroxycorticosteroids; Hydroxycorticosteroids; Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Weeks
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2017
• First Posted: March 17, 2017
• Study Start: April 1, 2017
• Primary Completion: April 25, 2020
• Study Completion: April 25, 2020
• Last Updated: May 4, 2020

Record last verified: 2020-05

Locations

DE (2)