Graves DiseaseCARD-GRAVESNCT06908369
Cardiac Symptoms in Patients With Treated Graves' Disease
An observational study of Graves Disease and Cardiac Arrhythmias, run by Ulla Feldt-Rasmussen at 1 site in Denmark.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Graves Disease, Cardiac Arrhythmias, Cardiac Structure and Function
- How many people
- 75 participants
- Where
- 1 siteDenmark
- Study dates
- 20 Sep 2021to 15 Oct 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Study population: Participants are recruited from the Endocrinology Outpatient Clinic at Rigshospitalet and Herlev/Gentofte Hospital.
Who may be able to join
- 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
Who cannot join
- Cardiovascular disease
- Deemed unsuitable by project staff (e.g. due to language problems)
- Pregnancy
- Alcohol abuse or other abuses
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Medical subject headings
- Graves Disease, Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with treated Graves' disease and cardiac symptoms | Patients with Graves' disease, who have been treated to biochemical euthyroidism but still experience cardiac symptoms. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: The cardiac examinations were performed during three study visits which extended over a period of approximately half a year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2025
- Study start20 Sep 2021
- Primary completion20 Jul 2025 (estimated)
- Study completion15 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Graves DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ulla Feldt-Rasmussen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ulla Feldt-Rasmussen, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Ulla Feldt-Rasmussen, MD; DMSc, Study director, Copenhagen University Hospital, RigshospitaletStig Haunsø, MD; DMSc, Study director, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06908369
- Sponsor's protocol ID
- Cardiac Symptoms in Graves
- Other IDs
- Rigshospitalet, Capital Region
- Acronym
- CARD-GRAVES
- Status last verified
- Mar 2025
- First submitted
- 18 Mar 2025
- Last updated
- 3 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Persistent Cardiac Symptoms in Patients With Adequately Treated Graves' Disease
- ClinicalTrials.gov ID
- NCT06908369
- Acronym / sponsor ID
- CARD-GRAVES / Cardiac Symptoms in Graves
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Ulla Feldt-RasmussenUniversity, hospital or other
- Study start
- 20 Sep 2021 (actual)
- Primary completion
- 20 Jul 2025 (estimated)
- Study completion
- 15 Oct 2025 (estimated)
- First posted
- 3 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with treated Graves' disease and cardiac symptoms | – | –Patients with Graves' disease, who have been treated to biochemical euthyroidism but still experience cardiac symptoms. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Participants are recruited from the Endocrinology Outpatient Clinic at Rigshospitalet and Herlev/Gentofte Hospital.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- Cardiovascular disease
- Deemed unsuitable by project staff (e.g. due to language problems)
- Pregnancy
- Alcohol abuse or other abuses
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Cardiac changes
Time frame: The cardiac examinations were performed during three study visits which extended over a period of approximately half a year.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ulla Feldt-Rasmussen, MD; DMSc study director
Copenhagen University Hospital, Rigshospitalet
Stig Haunsø, MD; DMSc study director
Copenhagen University Hospital, Rigshospitalet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Graves Disease and Cardiac Arrhythmias, run by Ulla Feldt-Rasmussen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 3 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiac changes (time frame: The cardiac examinations were performed during three study visits which extended over a period of approximately half a year.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2025.