Skip to main content
OpenTrials
Completed

NCT Number: NCT04391439

Heart Rhythm After Intravenous Methylprednisolone Administration

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Graves Disease Autoimmune Diseases Blood Pressure Cardiovascular Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Endocrine System Diseases Exophthalmos Eye Diseases Eye Diseases, Hereditary Genetic Diseases, Inborn Goiter Graves Ophthalmopathy Heart Diseases Heart Failure Heart Rhythm Disorder Hypertension Hyperthyroidism Immune System Diseases Orbital Diseases Thyroid Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

The clinical status of patients was evaluated before each pulse, including blood pressure monitoring, glucose level monitoring and symptoms of infection. HR and BP was measured continuously for 3 consecutive days (the day before, the day of IVMP and the day after IVMP) during 1st, 6th and 12th IVMP pulse, using 24-hour Holter ECG and ABMP. Serum laboratory tests for potassium, epinephrine and norepinephrine were measured 3 times the day before and the day of first IVMP pulse and 1 time the second and sixth day after 1st IVMP. Additionally, urine samples for potassium were collected 5 times the day of first IVMP pulse and 1 time the second and sixth day after 1st IVMP.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • active, moderate-to-severe GO according to EUGOGO classification
  • euthyroidism
  • completion of 12 IVMP pulses.

Exclusion criteria

  • cardiovascular morbidity (such as chronic heart failure and/or coronary heart disease)
  • uncontrolled hypertension (defined as systolic blood pressure (SBP) more than 140 mmHg and/or diastolic blood pressure (DBP) more than 90 mmHg)
  • contraindications to IVMP therapy
  • previous GCs treatment in the last 6 months.

Treatment and study plan

Intravenous Methylprednisolone

Drug

Primary outcomes

  1. 24-hour Holter ECG Monitoring - 1st pulse mean HR

    Time frame: 72 hours

    Analysis of changes in mean HR between day before and day of 1st pulse of IVMP, day of 1st IVMP and day after 1st IVMP, day before and day after 1st IVMP

  2. 24-hour Holter ECG Monitoring - 6th pulse mean HR

    Time frame: 72 hours

    Analysis of changes in mean HR between day before and day of 6th pulse of IVMP, day of 6th IVMP and day after 6th IVMP, day before and day after 6th IVMP

  3. 24-hour Holter ECG Monitoring - 12th mean HR

    Time frame: 72 hours

    Analysis of changes in mean HR between day before and day of 12th pulse of IVMP, day of 12th IVMP and day after 12th IVMP, day before and day after 12th IVMP

Secondary outcomes

  1. Serum potassium levels Day 0 - Day 1

    Time frame: 48 hours

    Change in value of potassium between day before and day of 1st pulse of IVMP

  2. Serum epinephrine levels Day 0 - Day 1

    Time frame: 48 hours

    Change in value of epinephrine between day before and day of 1st pulse of IVMP

  3. Serum norepinephrine levels Day 0 - Day 1

    Time frame: 48 hours

    Change in value of norepinephrine between day before and day of 1st pulse of IVMP

  4. Urine potassium levels Day 0

    Time frame: 24 hours

    Change in value of potassium during the day of 1st pulse of IVMP

  5. 72-hour ambulatory blood pressure monitoring (ABPM) - 1st pulse mean BP

    Time frame: 72 hours

    Analysis of changes in mean BP between day before and day of 1st pulse of IVMP, day of 1st IVMP and day after 1st IVMP, day before and day after 1st IVMP

  6. 72-hour ambulatory blood pressure monitoring (ABPM) - 6th pulse mean BP

    Time frame: 72 hours

    Analysis of changes in mean BP between day before and day of 6th pulse of IVMP, day of 6th IVMP and day after 6th IVMP, day before and day after 6th IVMP

  7. 72-hour ambulatory blood pressure monitoring (ABPM) - 12th pulse mean BP

    Time frame: 72 hours

    Analysis of changes in mean BP between day before and day of 12th pulse of IVMP, day of 12th IVMP and day after 12th IVMP, day before and day after 12th IVMP

Other outcomes

  1. Serum potassium levels Day 0 - Day 7

    Time frame: 7 days

    Change in value of potassium between day before and sixth day after 1st pulse of IVMP

  2. Serum potassium levels Day 0 - Day 2

    Time frame: 72 hours

    Change in value of potassium between day of 1st IVMP and day after 1st IVMP, day before and day after 1st IVMP

  3. Serum epinephrine levels Day 0 - Day 7

    Time frame: 7 days

    Change in value of epinephrine between day before and sixth day after 1st pulse of IVMP

  4. Serum epinephrine levels Day 0 - Day 2

    Time frame: 72 hours

    Change in value of epinephrine between day of 1st IVMP and day after 1st IVMP, day before and day after 1st IVMP

  5. Serum norepinephrine levels Day 0 - Day 7

    Time frame: 7 days

    Change in value of epinephrine between day before and sixth day after 1st pulse of IVMP

  6. Serum norepinephrine levels Day 0 - Day 2

    Time frame: 72 hours

    Change in value of norepinephrine between day of 1st IVMP and day after 1st IVMP, day before and day after 1st IVMP

  7. Urine potassium levels Day 1- Day 2

    Time frame: 48 hours

    Change in value of epinephrine between day of 1st IVMP and day after 1st pulse of IVMP

  8. Urine potassium levels Day 3 - Day 7

    Time frame: 5 days

    Change in value of epinephrine between second and sixth day after 1st IVMP

Sponsors and collaborators

Lead sponsor

Medical University of Warsaw

Other

Registry information

Official study title

Increased Heart Rhythm in Response to High-dose Intravenous Methylprednisolone Pulse Therapy of Moderate-to-severe Graves' Orbitopathy

Important dates

Study start
2011
Primary completion
2020
Study completion
2020
First posted
May 18, 2020
Registry last updated
May 18, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.