NCT03379181

Brief 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 ambient temperatures.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jul 2017

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 18, 2017

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

December 7, 2017

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 20, 2017

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 12, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 12, 2020

Completed
Last Updated

February 13, 2020

Status Verified

February 1, 2020

Enrollment Period

2.6 years

First QC Date

December 7, 2017

Last Update Submit

February 12, 2020

Conditions

Hyperthyroidism

Keywords

Brown adipose tissue (BAT)Hyperthyroidism

Outcome Measures

Primary Outcomes (1)

  • 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).

    90 minutes after propranolol application

Secondary Outcomes (6)

  • Respiratory quotient (RQ) before and after administration of propranolol.

    90 minutes after propranolol application

  • Difference in skin temperature

    90 minutes after propranolol application

  • Difference in REE from hyperthyroid to euthyroid state

    after 3 to 4 months

  • Difference in REE hyperthyroid state to euthyroid state

    after 6 to 7 months

  • Change in Body composition: percent body fat

    after 3 to 4 months

  • +1 more secondary outcomes

Study Arms (1)

Propranolol 80 mg

EXPERIMENTAL

Patients receive a single dose of 80 mg propranolol p.o.

Drug: Propranolol

Interventions

PropranololDRUG

Patients receive a single dose of 80 mg propranolol p.o.

Also known as: beta blockade
Propranolol 80 mg

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • 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,
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Basel, Department of Endocrinology

Basel, Canton of Basel-City, 4031, Switzerland

Location

Related Publications (2)

  • 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.

    PMID: 36743920DERIVED

  • Maushart 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.

    PMID: 34570185DERIVED

MeSH Terms

Conditions

Hyperthyroidism

Interventions

Propranolol

Condition Hierarchy (Ancestors)

Thyroid DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

PhenoxypropanolaminesPropanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsPropanolsAminesNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPolycyclic Compounds

Study Officials

  • Matthias J Betz, MD

    University Hospital, Basel, Switzerland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 7, 2017

First Posted

December 20, 2017

Study Start

July 18, 2017

Primary Completion

February 12, 2020

Study Completion

February 12, 2020

Last Updated

February 13, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)