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NCT04391439
Heart Rhythm After Intravenous Methylprednisolone Administration
trial testing Intravenous Methylprednisolone in Graves Disease in 40 participants. Completed in 20 February 2020.
20 February 2020
Quick facts
| Lead sponsor | Medical University of Warsaw |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 40 |
| Start date | 1 January 2011 |
| Primary completion | 20 February 2020 |
| Estimated completion | 20 February 2020 |
Drugs / interventions tested
- Intravenous Methylprednisolone — full drug profile →
Conditions studied
- Graves Disease — all drugs for Graves Disease →
- Graves Ophthalmopathy — all drugs for Graves Ophthalmopathy →
- Heart Rhythm Disorder — all drugs for Heart Rhythm Disorder →
- Hypertension — all drugs for Hypertension →
Sponsor
Medical University of Warsaw
Who can join
18 and older, any sex, with Graves Disease or Graves Ophthalmopathy. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
High doses of intravenous (iv.) glucocorticoids (GCs) are commonly used as a treatment for many autoimmune and inflammatory disorders. According to the European Group on Graves' Orbitopathy (EUGOGO) guidelines, intravenous methylprednisolone (IVMP) is an accepted first-line agent for active, moderate-to-severe and very severe Graves' orbitopathy (GO). This treatment is proven to be more efficient and safer than oral GCs. However, some patients may experience adverse cardiovascular effects during the administration of iv. GCs, which in rare cases may even be fatal. There are limited data, mostly obtained from case reports, reporting the occurrence of cardiac arrhythmias, acute myocardial infarction or heart failure. Increased heart rhythm (HR) has drawn attention of researchers as a possible adverse effect correlated with IVMP. During this study, investigators performed 72-hours of Holter ECG and ambulatory blood pressure monitoring (ABPM) to evaluate the impact of IVMP on patients with moderate-to-severe GO, concerning HR and blood pressure (BP) changes. In order to elucidate possible mechanism of observed changes, researchers investigated the level of potassium in serum and urine and catecholamines (epinephrine, norepinephrine) in serum. All patients were treated routinely according to EUGOGO recommendations with standard doses of methylprednisolone with standard recommended schedule. Inclusion criterion for the therapy was according to EUGOGO guidelines active, moderate-to-severe and active GO (12 pulses of IVMP 6x0.5g followed by 6x0.25g every week).
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
NIR Spectrometry Reveals Lack of Content Uniformity in Methylprednisolone Sodium Succinate.
Isaacs JT, Almeter PJ, Hasani E, Hunter AN, et al · · 2025 · PMID 41306797 · DOI 10.6084/m9.figshare.30057982
Verify or expand the search:
- PubMed search for NCT04391439
- Europe PMC full search
- ASCO Meeting Library
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Related trials
Other trials of Intravenous Methylprednisolone
Trials testing the same drug.
- NCT03876444 — Intravenous Methylprednisolone Versus Oral Prednisolone for Infantile Spasms · Phase 2, PHASE3 · unknown
Other recruiting trials for Graves Disease
Currently open trials in the same condition.
- NCT07480720 — Systemic Inflammation, Thyroid Autoimmunity and Neuroretinal Changes in Graves Disease · recruiting
- NCT07305818 — NEXUS Study: A Study to Test Single and Multiple Doses of MER511 Given to Adults With Graves' Disease · Phase 1 · recruiting
- NCT07286656 — A Study of GensSci098 in Subjects With Graves' Disease · Phase 1 · recruiting
- NCT07129642 — Allogeneic Anti-CD19 CAR-T for Refractory Graves' Disease · EARLY_PHASE1 · recruiting
- NCT07369063 — Impact of Vitamin D Therapy on Thyroid Function and Antibody Levels in Pediatric Graves' Disease · Phase 2 · recruiting
Other Medical University of Warsaw trials
Trials by the same sponsor.
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- NCT07398898 — Use of Augmented Reality Glasses and Noise-Cancelling Headphones to Reduce Dental Anxiety in Adult Patients · NA · recruiting
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04391439 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Medical University of Warsaw
- Last refreshed: 18 May 2020
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