Cardiac Symptoms in Patients With Treated Graves' Disease (CARD-GRAVES)
Persistent Cardiac Symptoms in Patients With Adequately Treated Graves' Disease
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.
Study Overview
Status
Detailed Description
Cardiac symptoms are common i patients with Graves' disease. These symptoms often disappear when hyperthyroidism is treated. However, a subgroup of patients with Graves' disease experiences persisting cardiac symptoms after treatment. The aim of the study is to describe these symptoms and investigate their origin.
A total of 75 patients are included in the study. Patients were recruited from the Department of Nephrology and Endocrinology at Copenhagen University Hospital Rigshospitalet and the Department of Internal Medicine, Section of Endocrinology at Herlev Gentofte Hospital, Denmark. The patients were identified by extracting a list of patients with the International Classification of Diseases 10 codes (ICD 10 codes) E050 and E059. Also, a list of patients with positive thyrotropin receptor antibody (TRAbI measurements was extracted.
All patients had a thorough cardiac work up including blood samples, 12-lead resting electrocardiogram, 24-hour electrocardiogram monitoring (Holter), transthoracic echocardiography, and exercise stress test. The focus was to investigate whether the cardiac symptoms could be explained by structural or functional changes of the heart or by cardiac arrhythmias.
All patients were questioned about their symptoms including: type of cardiac symptoms, frequency and when they occured. The focus was to gain knowledge on the clinical presentation of cardiac symptoms in the subgroup.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Copenhagen, Denmark
- Rigshospitalet
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patient with Graves' disease
- Between the ages of 18 and 55 years
- Has been euthyroid for at least three months prior to inclusion
- Experiences cardiac symptoms
Exclusion Criteria:
- Cardiovascular disease
- Deemed unsuitable by project staff (e.g. due to language problems)
- Pregnancy
- Alcohol abuse or other abuses
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Patients with treated Graves' disease and cardiac symptoms
Patients with Graves' disease, who have been treated to biochemical euthyroidism but still experience cardiac symptoms.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Cardiac changes
Time Frame: The cardiac examinations were performed during three study visits which extended over a period of approximately half a year.
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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.
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Ulla Feldt-Rasmussen, MD; DMSc, Rigshospitalet, Denmark
- Study Director: Stig Haunsø, MD; DMSc, Rigshospitalet, Denmark
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Cardiac Symptoms in Graves
- Rigshospitalet, Capital Region (Other Identifier: Rigshospitalet, Capital Region of Denmark)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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