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Cortisone and QTc-Interval

Sponsor
Asklepios Neurological Clinic Bad Salzhausen (Other)
Overall Status
Completed
CT.gov ID
NCT03082339
Collaborator
University of Giessen (Other)
105
Enrollment
2
Locations
36.8
Actual Duration (Months)
52.5
Patients Per Site
1.4
Patients Per Site Per Month

Study Details

Study Description

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?

Condition or Disease Intervention/Treatment Phase
  • Other: Cortisone

Study Design

Study Type:
Observational [Patient Registry]
Actual Enrollment :
105 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Influence of Cortisone on QTc-interval
Actual Study Start Date :
Apr 1, 2017
Actual Primary Completion Date :
Apr 25, 2020
Actual Study Completion Date :
Apr 25, 2020

Arms and Interventions

Arm Intervention/Treatment
Neurology

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

Other: Cortisone
Observation of QTc-interval
Pulmonology

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

Other: Cortisone
Observation of QTc-interval

Outcome Measures

Primary Outcome Measures

  1. Duration of QTc-interval [1 week]

    daily ECG controls and measuring QTc-interval

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University Giessen Gießen Germany 35394
2 Neurologische Klinik Bad Salzhausen Nidda Germany 63667

Sponsors and Collaborators

  • Asklepios Neurological Clinic Bad Salzhausen
  • University of Giessen

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Asklepios Neurological Clinic Bad Salzhausen
ClinicalTrials.gov Identifier:
NCT03082339
Other Study ID Numbers:
  • QTc25416
First Posted:
Mar 17, 2017
Last Update Posted:
May 4, 2020
Last Verified:
May 1, 2020
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Cortisone

Study Results

No Results Posted as of May 4, 2020