HyperthyroidismPhase 4NCT03393728
Heart Rate Variability and Hyperthyroidism: Evaluation of the Short-term Effects of Propanolol
A Phase 4 study testing Propanolol in people with Hyperthyroidism, run by Yaounde Central Hospital.
Trial summary
Objective: The aim of our study was to evaluate the short term effects of Propanolol on heart rate variability in patients with hyperthyroidism. Design: In ten patients newly diagnosed as having hyperthyroidism and naïve of all treatment specific for hyperthyroidism, we evaluated the short term effects of Propanolol… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hyperthyroidism
- What is being tested?
- Propanolol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2008to 30 Sep 2009
- 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
- consenting patients referred to or diagnosed at the National Centre of Obesity of the Yaounde Central Hospital as having hyperthyroidism
- naïve of all treatment specific for hyperthyroidism.
- aged 18-70 years
Who cannot join
- Patients already under a specific treatment for hyperthyroidism
- Patients taking beta blockers or any other cardiospecific treatment
- Patients presenting complications including acute thyrotoxic crisis, or symptomatic cardiac failure
- Contraindications to the prescription of beta blockers
About this study
Official title: Short Term Effects of Propanolol on Heart Rate Variability of Hyperthyroidism
Objective: The aim of our study was to evaluate the short term effects of Propanolol on heart rate variability in patients with hyperthyroidism.
Design: In ten patients newly diagnosed as having hyperthyroidism and naïve of all treatment specific for hyperthyroidism, we evaluated the short term effects of Propanolol on heart rate variability (HRV).
Methods: We measured heart rate variability by power spectral analysis during 2 hours of rest and during Ewing's tests before and after the administration of Propanolol 40mg/12 hours orally for 72 hours.
Read the detailed description
Objective: The aim of our study was to evaluate the short term effects of Propanolol on heart rate variability in patients with hyperthyroidism.
Design: In ten patients newly diagnosed as having hyperthyroidism and naïve of all treatment specific for hyperthyroidism, we evaluated the short term effects of Propanolol on heart rate variability (HRV).
Methods: We measured heart rate variability by power spectral analysis during 2 hours of rest and during Ewing's tests before and after the administration of Propanolol 40mg/12 hours orally for 72 hours. Other outcomes included mean heart rate, mean R-R interval during 2-hour rest.
The study questions the systematic adjunction of Propanolol early in the treatment of hyperthyroidism.
- Conditions
- Hyperthyroidism
- Being tested
- Propanolol
- Keywords
- hyperthyroidism, heart rate variability, propanolol, Africa
- Medical subject headings
- Hyperthyroidism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PropanololDrug
Also called Avlocardyl
72-hour propanolol before specific treatment of hyperthyroidism
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | 72-hour propanolol before specific treatment of hyperthyroidism Receives: Drug: Propanolol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart rate variability
Sympatho vagal tone measures
Measured: 72 hours
Secondary outcomes (1)
Heart rate
Heart rate
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2018
- Study start1 Sep 2008
- Primary completion30 Dec 2008
- Study completion30 Sep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HyperthyroidismStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Open label Before and After design
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yaounde Central Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Sobngwi Eugene, Yaounde Central Hospital
- Investigators
- Jean Claude N Mbanya, MD, PhD, Study chair, Yaounde Central Hospital and University of Yaounde 1Eugène Sobngwi, Principal investigator, Hôpital Central de Yaoundé et Université de Yaoundé 1
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03393728
- Sponsor's protocol ID
- YaoundeCH
- Status last verified
- Jan 2018
- First submitted
- 21 Dec 2017
- Last updated
- 8 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Availability to researchers making a formal request with restrictions in relation to national regulations on data sharing
Publications
Tankeu AT, Azabji-Kenfack M, Nganou CN, Ngassam E, Kuate-Mfeukeu L, Mba C, Dehayem MY, Mbanya JC, Sobngwi E. Effect of propranolol on heart rate variability in hyperthyroidism. BMC Res Notes. 2018 Feb 22;11(1):151. doi: 10.1186/s13104-018-3224-x.
PubMed 29471876
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short Term Effects of Propanolol on Heart Rate Variability of Hyperthyroidism
- ClinicalTrials.gov ID
- NCT03393728
- Acronym / sponsor ID
- YaoundeCH
- Conditions
- Hyperthyroidism
- Keywords
- hyperthyroidism, heart rate variability, propanolol, Africa
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Yaounde Central HospitalOther government
- Study start
- 1 Sep 2008 (actual)
- Primary completion
- 30 Dec 2008 (actual)
- Study completion
- 30 Sep 2009 (actual)
- First posted
- 8 Jan 2018 (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.
Objective: The aim of our study was to evaluate the short term effects of Propanolol on heart rate variability in patients with hyperthyroidism.
Design: In ten patients newly diagnosed as having hyperthyroidism and naïve of all treatment specific for hyperthyroidism, we evaluated the short term effects of Propanolol on heart rate variability (HRV).
Methods: We measured heart rate variability by power spectral analysis during 2 hours of rest and during Ewing's tests before and after the administration of Propanolol 40mg/12 hours orally for 72 hours.
Detailed description
Objective: The aim of our study was to evaluate the short term effects of Propanolol on heart rate variability in patients with hyperthyroidism.
Design: In ten patients newly diagnosed as having hyperthyroidism and naïve of all treatment specific for hyperthyroidism, we evaluated the short term effects of Propanolol on heart rate variability (HRV).
Methods: We measured heart rate variability by power spectral analysis during 2 hours of rest and during Ewing's tests before and after the administration of Propanolol 40mg/12 hours orally for 72 hours. Other outcomes included mean heart rate, mean R-R interval during 2-hour rest.
The study questions the systematic adjunction of Propanolol early in the treatment of hyperthyroidism.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open label Before and After design
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Drug: Propanolol72-hour propanolol before specific treatment of hyperthyroidism |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- consenting patients referred to or diagnosed at the National Centre of Obesity of the Yaounde Central Hospital as having hyperthyroidism
- naïve of all treatment specific for hyperthyroidism.
- aged 18-70 years
Key exclusion criteria (4 listed)
- Patients already under a specific treatment for hyperthyroidism
- Patients taking beta blockers or any other cardiospecific treatment
- Patients presenting complications including acute thyrotoxic crisis, or symptomatic cardiac failure
- Contraindications to the prescription of beta blockers
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 |
|---|---|---|
| PropanololAlso: Avlocardyl72-hour propanolol before specific treatment of hyperthyroidism | Drug | Intervention |
Primary outcome
Heart rate variability
Time frame: 72 hours
Sympatho vagal tone measures
1 secondary outcome
Heart rate
Time frame: 72 hours
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 8 Jan 2018.
- Derived from this study: PubMed 29471876Tankeu AT, Azabji-Kenfack M, Nganou CN, Ngassam E, Kuate-Mfeukeu L, Mba C, Dehayem MY, Mbanya JC, Sobngwi E. Effect of propranolol on heart rate variability in hyperthyroidism. BMC Res Notes. 2018 Feb 22;11(1):151. doi: 10.1186/s13104-018-3224-x.
- Individual participant dataSharing planned: Undecided. Availability to researchers making a formal request with restrictions in relation to national regulations on data sharing
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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.
Jean Claude N Mbanya, MD, PhD study chair
Yaounde Central Hospital and University of Yaounde 1
Eugène Sobngwi principal investigator
Hôpital Central de Yaoundé et Université de Yaoundé 1
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Propanolol in people with Hyperthyroidism, run by Yaounde Central Hospital.
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 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: finished, as of the sponsor's last update on 8 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Heart rate variability (time frame: 72 hours). 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 NCT03393728, which also lists 1 linked publication.
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 8 Jan 2018.