Heart Rhythm After Intravenous Methylprednisolone Administration

NCT04391439 | Completed

• 1 other identifier: IVMPheartrate
• Study Type: observational
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

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).

Conditions

Graves Disease; Graves Ophthalmopathy; Heart Rhythm Disorder; Hypertension; Blood Pressure; Heart Failure

Outcome Measures

Primary Outcomes (3)

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

  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

  72 hours

• 24-hour Holter ECG Monitoring - 6th pulse mean HR

  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

  72 hours

• 24-hour Holter ECG Monitoring - 12th mean HR

  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

  72 hours

Secondary Outcomes (7)

• Serum potassium levels Day 0 - Day 1

  48 hours

• Serum epinephrine levels Day 0 - Day 1

  48 hours

• Serum norepinephrine levels Day 0 - Day 1

  48 hours

• Urine potassium levels Day 0

  24 hours

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

  72 hours

Other Outcomes (8)

• Serum potassium levels Day 0 - Day 7

  7 days

• Serum potassium levels Day 0 - Day 2

  72 hours

• Serum epinephrine levels Day 0 - Day 7

  7 days

Study Arms (1)

active, moderate-to-severe GO

Each participant received IVMP according to EUGOGO recommendations (cumulative dose of methylprednisolone 4.5 g, treatment duration 12 weeks in single weekly intravenous pulses, first 6 weeks 0.5g of IVMP, next 6 weeks 0.25g of IVMP).

Drug: Intravenous Methylprednisolone

Interventions

Intravenous Methylprednisolone DRUG

active, moderate-to-severe GO

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients admitted to the clinic for routine treatment of active, moderate-to-severe GO

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medical University of Warsaw: lead

Biospecimen

Retention: SAMPLES WITHOUT DNA

All assays were performed in sera obtained from venous blood samples and analysed immediately after blood sampling in The Endocrinology Research Laboratory in the hospital. All samples were centrifugated for plasma immediately after delivery (15 min; 1000 xg) and separated for both categories (EDTA and heparin) - 2 x 400 ul for test tubes with protease inhibitors and 4 x 500 ul with no additives. Then all assays were frozen immediately to -70°C.

MeSH Terms

Conditions

Graves Disease; Graves Ophthalmopathy; Hypertension; Heart Failure

Condition Hierarchy (Ancestors)

Exophthalmos; Orbital Diseases; Eye Diseases; Goiter; Thyroid Diseases; Endocrine System Diseases; Hyperthyroidism; Autoimmune Diseases; Immune System Diseases; Eye Diseases, Hereditary; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Vascular Diseases; Cardiovascular Diseases; Heart Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 5, 2020
• First Posted: May 18, 2020
• Study Start: January 1, 2011
• Primary Completion: February 20, 2020
• Study Completion: February 20, 2020
• Last Updated: May 18, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will share
• Time Frame: The results of the study will be published in 2020