HyperthyroidismPhase 4HEATNCT03379181
Thermogenesis in Hyperthyroidism and Effect of Anti-Adrenergic Therapy
A Phase 4 study testing Propranolol in people with Hyperthyroidism, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
The overall objective of the HEAT study is to determine the acute effect of propranolol on energy expenditure in patients suffering from hyperthyroidism and to evaluate the consequences of the change of hyper- to euthyroidism on metabolism during the course of treatment, especially with regard to the reaction to cold… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hyperthyroidism
- What is being tested?
- Propranolol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteSwitzerland
- Study dates
- 18 Jul 2017to 12 Feb 2020
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Informed Consent as documented by signature
- Age 18 to 70 years
- Hyperthyroidism: Thyroid-stimulating Hormone (TSH) below 0.2 mU and free T4 at or above 25 pmol/L or free T3 at or above 8 pmol/L.
Who cannot join
- Contraindications to propranolol: hypersensitivity or allergy
- Therapy with a beta blocker for reasons other than hyperthyroidism (e.g. cardiac arrhythmia or heart failure)
- Treatment with amiodarone
- Women who are pregnant or breast feeding,
- Intention to become pregnant during the course of the study,
- History of asthma or chronic obstructive pulmonary disease
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- Occlusive peripheral artery disease; Raynaud's syndrome.
- Other clinically significant concomitant disease states:
- Known renal failure (GFR < 50 ml/min)
- Known hepatic dysfunction
- known heart failure or unstable angina pectoris
- Known or suspected non-compliance, drug or alcohol abuse,
- Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant,
- Participation in another study with investigational drug within the 30 days preceding and during the present study,
- Previous enrolment into the current study,
- Enrolment of the investigator, his/her family members, employees and other dependent persons.
- ECG-criteria
- Resting heart rate below 60 bpm
- Complete left bundle branch block
- Atrioventricular block (AV-block) grade 2 or 3
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Basel, Department of Endocrinology
Basel, Canton of Basel-City, 4031
About this study
The overall objective of the HEAT study is to determine the acute effect of propranolol on energy expenditure in patients suffering from hyperthyroidism and to evaluate the consequences of the change of hyper- to euthyroidism on metabolism during the course of treatment, especially with regard to the reaction to cold ambient temperatures.
- Conditions
- Hyperthyroidism
- Being tested
- Propranolol
- Keywords
- Brown adipose tissue (BAT), Hyperthyroidism
- Medical subject headings
- Hyperthyroidism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PropranololDrug
Also called beta blockade
Patients receive a single dose of 80 mg propranolol p.o.
| Study group | Role | What they receive |
|---|---|---|
| Propranolol 80 mg | Experimental | Patients receive a single dose of 80 mg propranolol p.o. Receives: Drug: Propranolol |
What is being measured
The primary outcome is the main question the study is designed to answer.
acute effect of propranolol on energy expenditure in patients suffering from hyperthyroidism
difference in resting energy expenditure (REE) measured single 90 minutes after an oral dose of 80 mg of propranolol compared to resting energy expenditure measured during the thirty minutes prior to administration of propranolol (ΔREEPropranolol).
Measured: 90 minutes after propranolol application
Secondary outcomes (6)
Respiratory quotient (RQ) before and after administration of propranolol.
Difference in respiratory quotient (RQ) before and after administration of propranolol.
Measured: 90 minutes after propranolol application
Difference in skin temperature
Supraclavicular skin temperature in patients with hyperthyroidism after a single dose of 80 mg Propranolol compared to supraclavicular temperature before Propranolol.
Measured: 90 minutes after propranolol application
Difference in REE from hyperthyroid to euthyroid state
indirect calorimetry to determine resting energy expenditure
Measured: after 3 to 4 months
Difference in REE hyperthyroid state to euthyroid state
indirect calorimetry to determine resting energy expenditure
Measured: after 6 to 7 months
Change in Body composition: percent body fat
dual xray absorption scan
Measured: after 3 to 4 months
Cold induced thermogenesis (CIT) in patients with hyperthyroidism
Cold induced thermogenesis: Increase in energy expenditure above resting metabolic rate in response to a mild cold stimulus during hyperthyroidism as compared to euthyroidism.
Measured: after 3 to 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2017
- Study start18 Jul 2017
- Primary completion12 Feb 2020
- Study completion12 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HyperthyroidismStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Matthias J Betz, MD, Principal investigator, University Hospital, Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03379181
- Sponsor's protocol ID
- EKNZ 2017-02044
- Acronym
- HEAT
- Status last verified
- Feb 2020
- First submitted
- 7 Dec 2017
- Last updated
- 13 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Senn JR, Loliger RC, Fischer JGW, Bur F, Maushart CI, Betz MJ. Acute effect of propranolol on resting energy expenditure in hyperthyroid patients. Front Endocrinol (Lausanne). 2023 Jan 19;13:1026998. doi: 10.3389/fendo.2022.1026998. eCollection 2022.
PubMed 36743920Maushart CI, Senn JR, Loeliger RC, Siegenthaler J, Bur F, Fischer JGW, Betz MJ. Resting Energy Expenditure and Cold-induced Thermogenesis in Patients With Overt Hyperthyroidism. J Clin Endocrinol Metab. 2022 Jan 18;107(2):450-461. doi: 10.1210/clinem/dgab706.
PubMed 34570185
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thermogenesis in Hyperthyroidism and Effect of Anti-Adrenergic Therapy
- ClinicalTrials.gov ID
- NCT03379181
- Acronym / sponsor ID
- HEAT / EKNZ 2017-02044
- Conditions
- Hyperthyroidism
- Keywords
- Brown adipose tissue (BAT), Hyperthyroidism
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 18 Jul 2017 (actual)
- Primary completion
- 12 Feb 2020 (actual)
- Study completion
- 12 Feb 2020 (actual)
- First posted
- 20 Dec 2017 (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.
The overall objective of the HEAT study is to determine the acute effect of propranolol on energy expenditure in patients suffering from hyperthyroidism and to evaluate the consequences of the change of hyper- to euthyroidism on metabolism during the course of treatment, especially with regard to the reaction to cold ambient temperatures.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Propranolol 80 mg | Experimental | Drug: PropranololPatients receive a single dose of 80 mg propranolol p.o. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Informed Consent as documented by signature
- Age 18 to 70 years
- Hyperthyroidism: Thyroid-stimulating Hormone (TSH) below 0.2 mU and free T4 at or above 25 pmol/L or free T3 at or above 8 pmol/L.
Key exclusion criteria (20 listed)
- Contraindications to propranolol: hypersensitivity or allergy
- Therapy with a beta blocker for reasons other than hyperthyroidism (e.g. cardiac arrhythmia or heart failure)
- Treatment with amiodarone
- Women who are pregnant or breast feeding,
- Intention to become pregnant during the course of the study,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PropranololAlso: beta blockadePatients receive a single dose of 80 mg propranolol p.o. | Drug | Propranolol 80 mg |
Primary outcome
acute effect of propranolol on energy expenditure in patients suffering from hyperthyroidism
Time frame: 90 minutes after propranolol application
difference in resting energy expenditure (REE) measured single 90 minutes after an oral dose of 80 mg of propranolol compared to resting energy expenditure measured during the thirty minutes prior to administration of propranolol (ΔREEPropranolol).
6 secondary outcomes
Respiratory quotient (RQ) before and after administration of propranolol.
Time frame: 90 minutes after propranolol application
Difference in skin temperature
Time frame: 90 minutes after propranolol application
Difference in REE from hyperthyroid to euthyroid state
Time frame: after 3 to 4 months
Difference in REE hyperthyroid state to euthyroid state
Time frame: after 6 to 7 months
Change in Body composition: percent body fat
Time frame: after 3 to 4 months
Cold induced thermogenesis (CIT) in patients with hyperthyroidism
Time frame: after 3 to 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2020.
- Derived from this study: PubMed 36743920Senn JR, Loliger RC, Fischer JGW, Bur F, Maushart CI, Betz MJ. Acute effect of propranolol on resting energy expenditure in hyperthyroid patients. Front Endocrinol (Lausanne). 2023 Jan 19;13:1026998. doi: 10.3389/fendo.2022.1026998. eCollection 2022.
- Derived from this study: PubMed 34570185Maushart CI, Senn JR, Loeliger RC, Siegenthaler J, Bur F, Fischer JGW, Betz MJ. Resting Energy Expenditure and Cold-induced Thermogenesis in Patients With Overt Hyperthyroidism. J Clin Endocrinol Metab. 2022 Jan 18;107(2):450-461. doi: 10.1210/clinem/dgab706.
- Individual participant dataSharing planned: No
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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.
Matthias J Betz, MD principal investigator
University Hospital, Basel, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Propranolol in people with Hyperthyroidism, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
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 3 inclusion and 20 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: finished, as of the sponsor's last update on 13 Feb 2020. 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 Switzerland. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
acute effect of propranolol on energy expenditure in patients suffering from hyperthyroidism (time frame: 90 minutes after propranolol application). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03379181, which also lists 2 linked publications.
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 13 Feb 2020.