Cortisone and QTc-Interval

NCT ID: NCT03082339

Last Updated: 2020-05-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

105 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-04-01

Study Completion Date

2020-04-25

Brief Summary

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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

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Conditions

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QTc-interval

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Neurology

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

Cortisone

Intervention Type OTHER

Observation of QTc-interval

Pulmonology

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

Cortisone

Intervention Type OTHER

Observation of QTc-interval

Interventions

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Cortisone

Observation of QTc-interval

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Giessen

OTHER

Sponsor Role collaborator

Asklepios Neurological Clinic Bad Salzhausen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University Giessen

Giessen, , Germany

Site Status

Neurologische Klinik Bad Salzhausen

Nidda, , Germany

Site Status

Countries

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Germany

References

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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.

Reference Type BACKGROUND
PMID: 21457289 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21098441 (View on PubMed)

Other Identifiers

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QTc25416

Identifier Type: -

Identifier Source: org_study_id

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