QTc-interval Clinical Trial
Official title:
Influence of Cortisone on QTc-interval
| NCT number | NCT03082339 |
| Other study ID # | QTc25416 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | April 1, 2017 |
| Est. completion date | April 25, 2020 |
| Verified date | May 2020 |
| Source | Asklepios Neurological Clinic Bad Salzhausen |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational [Patient Registry] |
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?
| Status | Completed |
| Enrollment | 105 |
| Est. completion date | April 25, 2020 |
| Est. primary completion date | April 25, 2020 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Germany | University Giessen | Gießen | |
| Germany | Neurologische Klinik Bad Salzhausen | Nidda |
| Lead Sponsor | Collaborator |
|---|---|
| Asklepios Neurological Clinic Bad Salzhausen | University of Giessen |
Germany,
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. — View Citation
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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Duration of QTc-interval | daily ECG controls and measuring QTc-interval | 1 week |