Cortisone and QTc-Interval

May 1, 2020 updated by: Asklepios Neurological Clinic Bad Salzhausen

Influence of Cortisone on QTc-interval

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?

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

105

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Gießen, Germany, 35394
        • University Giessen
      • Nidda, Germany, 63667
        • Neurologische Klinik Bad Salzhausen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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).

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of QTc-interval
Time Frame: 1 week
daily ECG controls and measuring QTc-interval
1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Asklepios Neurological Clinic Bad Salzhausen

Collaborators

University of Giessen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2017

Primary Completion (Actual)

April 25, 2020

Study Completion (Actual)

April 25, 2020

Study Registration Dates

First Submitted

March 12, 2017

First Submitted That Met QC Criteria

March 16, 2017

First Posted (Actual)

March 17, 2017

Study Record Updates

Last Update Posted (Actual)

May 4, 2020

Last Update Submitted That Met QC Criteria

May 1, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • QTc25416

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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