Cardiac Symptoms in Patients With Treated Graves' Disease

NCT06908369 | Active Not Recruiting

• 2 other identifiers: Cardiac Symptoms in GravesRigshospitalet, Capital Region
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

Hyperthyroidism is a condition with increased production of thyroid hormone from the thyroid gland. Hyperthyroidism affects the heart's inotropy (contractile force) and chronotropy (rhythm). Therefore, patients often experience symptoms such as increased/irregular heart rate, pounding heartbeats, and shortness of breath. The cardiac symptoms often improve when hyperthyroidism is treated and biochemical euthyroidism is achieved. However, knowledge of the long-term effects on the heart is limited. Existing studies have generally shown that patients with hyperthyroidism have an increased morbidity and mortality. The investigators conducted a questionnaire survey which showed that about 38% of patients with Graves' disease continue to experience cardiac symptoms even months after normalization of thyroid hormone concentrations in the blood. This observation supports the presence of a persistent cardiovascular dysfunction, which may be due to a modulation of genomic or non-genomic factors with an effect on the cardiovascular system. These reflections are the focus of this clinical study. The aim of the study is to investigate the possible pathophysiology for this new "syndrome" in biochemically euthyroid patients. It is not a repetition of previous similar experiments.

Conditions

Graves Disease; Cardiac Arrhythmias; Cardiac Structure and Function

Outcome Measures

Primary Outcomes (1)

• Cardiac changes

  The patients were examined for cardiac arrhythmias and structural and functional changes of the heart with resting 12-lead ECG, 24-hour ambulatory ECG monitoring, transthoracic echocardiography, and exercise stress test. ECG analyses included: heart rate, PR-interval, QRS-duration, and QT-interval. Any presence of abnormal cardiac axis, bundle branch block, atrioventricular (AV) block, ventricular hypertrophy or atrial enlargement was noted. Analysis of the 24-hour ECG recording including heart rate, detection of arrythmia, heart block, and reported symptoms. The echocardiographic analysis consisted of the following measurements: left ventricular dimensions, left ventricular volumes, left ventricular function, left atrial volume, right ventricular dimensions, right ventricular function, and pulmonary artery pressure. Analysis of the exercise stress test included blood pressure, heart rate, and ECG-changes indicating myocardial ischemia and arrhythmias.

  The cardiac examinations were performed during three study visits which extended over a period of approximately half a year.

Study Arms (1)

Patients with treated Graves' disease and cardiac symptoms

Patients with Graves' disease, who have been treated to biochemical euthyroidism but still experience cardiac symptoms.

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Participants are recruited from the Endocrinology Outpatient Clinic at Rigshospitalet and Herlev/Gentofte Hospital.

You may qualify if:

• Patient with Graves' disease
• Between the ages of 18 and 55 years
• Experiences cardiac symptoms

You may not qualify if:

• Cardiovascular disease
• Deemed unsuitable by project staff (e.g. due to language problems)
• Pregnancy
• Alcohol abuse or other abuses

Sponsors & Collaborators

• Ulla Feldt-Rasmussen: lead

Study Sites (1)

Rigshospitalet

Copenhagen, Denmark

Location

Biospecimen

Retention: SAMPLES WITH DNA

60 ml of blood is drawn and transferred to different test tubes with different chemical additives. The blood samples are used for determination of biochemical, hematological and immunochemical parameters in accordance with Rigshospitalet's LabPortal. 3 x 9 ml of blood is drawn for genetic analyses. The blood is transferred to a glass with Ethylenediaminetetraacetic acid (EDTA) and glass with Trasylol and frozen and stored at -80 degrees.

MeSH Terms

Conditions

Graves Disease; Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Exophthalmos; Orbital Diseases; Eye Diseases; Goiter; Thyroid Diseases; Endocrine System Diseases; Hyperthyroidism; Autoimmune Diseases; Immune System Diseases; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ulla Feldt-Rasmussen, MD; DMSc

  Rigshospitalet, Denmark

  STUDY DIRECTOR

• Stig Haunsø, MD; DMSc

  Rigshospitalet, Denmark

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, DMSc, Professor Emerita, Senior Research Consultant

Study Record Dates

• First Submitted: March 18, 2025
• First Posted: April 3, 2025
• Study Start: September 20, 2021
• Primary Completion: July 20, 2025
• Study Completion: October 15, 2025
• Last Updated: April 3, 2025

Record last verified: 2025-03

Locations

DK (1)