HealthyPhase 4NCT01849861
Cardiopulmonary Capacity in Elderly With Different Ranges of Serum Thyroid Stimulating Hormone
A Phase 4 study testing Methimazole in people with Healthy, run by Universidade Federal do Rio de Janeiro at 1 site in Brazil.
Trial summary
The purpose of this study is to correlate in an elderly population (≥ 65 years), the different levels of serum TSH, with cardiopulmonary capacity, quality of life, depressive symptoms and cognition. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Methimazole
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteBrazil
- Study dates
- Sep 2011to Sep 2014
- 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Age ≥ 65 years.
- Healthy Men and women
- Registration at the University Hospital Clementino Fraga Filho (HUCFF).
Who cannot join
- Hypothalamic-pituitary disease
- Congestive cardiac insufficiency, chronic renal failure, acute renal failure, stroke, chronic obstructive pulmonary disease, asthma, cancer and / or cirrhosis.
- Diseases of the aorta, peripheral vascular disease, coronary artery disease (including angina, history of prior myocardial infarction or angina, or history of cardiac catheterization and angioplasty).
- Use of corticosteroids, amiodarone or dopamine, as well as any drug that interferes with the levels of thyroid hormones and / or thyroid function.
- Use of drugs that interfere with autonomic adaptation mechanism, such as beta-blockers, prolopa and calcium channel blockers. Hypertensive patients without use of such drugs may be included.
- Patients bedridden, wheelchair or with physical limitations (joint and muscle) to prevent the standing position for at least 20 minutes and the realization of the cardiopulmonary exercise test.
- Obesity with a body mass index equal or greater than 35 kg/m2.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Universidade Federal do Rio de Janeiro
Rio de Janeiro, Rio de Janeiro, 21941-590
Dhiãnah SO Chachamovitz, MD, +552126203063, dhianahsantini@gmail.com
Patrícia de Fátima S Teixeira, MD, PhD, +552125622748, pfatima@hucff.ufrj.br
About this study
Official title: Cardiopulmonary Capacity In Different Quartiles Ranges Of Reference For Serum Thyroid Stimulating Hormone (TSH): Sectional Evaluation And Effect Of The Use Of Methimazole In Elderly Population
The purpose of this study is to correlate in an elderly population (≥ 65 years), the different levels of serum TSH, with cardiopulmonary capacity, quality of life, depressive symptoms and cognition. And assess whether the increased serum TSH to the upper half of the normal range, through the use of antithyroid drugs, is associated with improvements in these parameters.
Read the detailed description
Specific Objectives:
Describe the cardiopulmonary capacity in elderly people with 65 years old or more, in different quartiles of normal range for serum TSH.
Assess the quality of life, mini mental health status and depression scale in seniors aged 65 or older, in different quartiles of normal range for serum TSH.
Quantify the possible effects related to the use of antithyroid drugs in cardiopulmonary capacity, quality of life, mini mental health status and depression scale in elderly people aged 65 or more, with the initial serum TSH at the lower limit of the normal range (1.0 milli-International unit/ml) (mIU/ml).
Justification:
Despite evidence that in the elderly population the mean serum TSH tends to be higher as compared to younger adults, there isn't a curve of normal range of TSH for this specific population (more shifted to the right, which would increase the number of diagnoses for subclinical hyperthyroidism).
Thus, elderly individuals, even when classified as euthyroidism, but presenting TSH in the normal lower range, may present at a greater risk of cardiovascular disease and therefore, may have indication for treatment.
These findings motivate and justify this study design, which may have great clinical relevance in the scientific community for its originality, and important clinical applicability.
Materials and Methods:
If the patient agrees to participate, an appointment will be scheduled at HUCFF that will be made: anamnesis, review of medical records, clinical examination and signing the Informed Consent Form (ICF).
Secondly, they will be guided and directed to: laboratory analysis for serum dosage of TSH and free thyroxine (FT4), cardiopulmonary exercise testing and application of the questionnaires of quality of life, mini mental health status and depression.
The study comprised of two parts:
Phase 1: Sectional:
- Analysis of variables.
- Sample as a whole and according to the quartiles of the reference range for serum TSH, with comparisons between groups.
- 1st Quartile: TSH: 0.4 to 1.0 mIU / ml.
- 2nd Quartile: TSH: 1.0 to 2.0 mIU / ml.
- 3rd Quartile: TSH: 2.0 to 3.0 mIU / ml.
- 4th Quartile: TSH: 3.0 to 4.0 mIU / ml Phase 2: Clinical uncontrolled. Patients with serum TSH initially on the 1st. Quartile (TSH: 0.4 to 1.0 mIU / ml) will receive treatment with Methimazole (initial dose of 5mg/day) with the goal of raising the TSH values to range between 2.0 and 4.0 mIU / ml (the half upper range of normal).
After six months with TSH in the target range (2.0 and 4.0 mIU / ml), these patients will be subjected to the same examination protocol performed at baseline and assessed to the effects of treatment on outcome variables.
Variables considered in this study:
- TSH and FT4
- Questionnaire of Quality of life for older adults (WHOQOL-OLD)
- Mini-Mental State Examination
- Geriatric Depression Scale
- Cardiopulmonary exercise testing - cardiopulmonary capacity Variables to be analyzed at rest, peak of the exercise and recovery: Heart rate, systolic blood pressure and diastolic blood pressure.
Variables to be assessed at peak effort: pulmonary ventilation, oxygen consumption, carbon dioxide production, ventilatory equivalent for oxygen and carbon dioxide, respiratory quotient, oxygen pulse, fraction of expired oxygen and carbon dioxide.
- Conditions
- Healthy
- Being tested
- Methimazole
- Keywords
- Cardiopulmonary Capacity, Ranges of TSH, Elderly Population
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MethimazoleDrug
Also called a single group
Patients with serum TSH initially on the 1st. Quartile (TSH: 0.4 to 1.0 mIU / ml) will receive treatment with Methimazole (initial dose of 5mg/day) with the goal of raising the TSH values to range between 2.0 and 4.0 mIU / ml (the half upper range of normal).
After six months with TSH in the target range (2.0 and 4.0 mIU / ml), these patients will be subjected to the same examination protocol performed at baseline and assessed to the effects of treatment on outcome variables.
Variables considered in this study:
- TSH and FT4
- Questionnaire of Quality of life for older adults (WHOQOL-OLD)
- Mini-Mental State Examination
- Geriatric Depression Scale
- Cardiopulmonary exercise testing - cardiopulmonary capacity
| Study group | Role | What they receive |
|---|---|---|
| Methimazole, | Experimental | Patients with serum TSH initially on the 1st. Quartile (TSH: 0.4 to 1.0 mIU / ml) will receive treatment with Methimazole (initial dose of 5mg/day) with the goal of raising the TSH values to range between 2.0 and 4.0 mIU / ml (the half upper range of normal).
After six months with TSH in the target range (2.0 and 4.0 mIU / ml), these patients will be subjected to the same examination protocol performed at baseline and assessed to the effects of treatment on outcome variables.
Variables considered in this study:
* TSH and FT4
* Questionnaire of Quality of life for older adults (WHOQOL-OLD)
* Mini-Mental State Examination
* Geriatric Depression Scale
* Cardiopulmonary exercise testing - cardiopulmonary capacity Receives: Drug: Methimazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlate in a population of more than 65 years old, the different levels of serum TSH, with cardiopulmonary capacity and these effects from baseline after treatment with antithyroid drugs
Describe the cardiopulmonary capacity in elderly health population of 65 years old or more, in different quartiles of normal range for serum TSH.
- Assess the outcome in the cardiopulmonary capacity in seniors aged 65 years old or more, in different quartiles of normal range for serum TSH.
- Quantify the possible changes from baseline related to the use of antithyroid drugs in cardiopulmonary capacity in patients aged 65 or more, with the initial serum TSH at the lower limit of the normal range (1.0 mIU/ml)to values of TSH more than 2.0mUI/ml for six months.
Measured: six months
Secondary outcomes (3)
Assess the quality of life in seniors aged 65 years old or older, in different quartiles of normal range for serum TSH and these changes from baseline after use of methimazole
Describe the quality of life in elderly health population of 65 years old or more, in different quartiles of normal range for serum TSH.
- Assess the outcome in quality of life in seniors aged 65 olde or more, in different quartiles of normal range for serum TSH
- Quantify the possible changes from baseline related to the use of antithyroid drugs in quality of life in patients aged 65 or more, with the initial serum TSH at the lower limit of the normal range (1.0 mIU/ml)to values of TSH more than 2.0mUI/ml for six months..
Measured: six months
Assess the mini mental health status in seniors aged 65 years old or older, in different quartiles of normal range for serum TSH and these changes from baseline after use of methimazole
Describe the mini mental health status in elderly health population of 65 years old or more, in different quartiles of normal range for serum TSH.
- Assess the outcome in mini mental health status in seniors aged 65 olde or more, in different quartiles of normal range for serum TSH.
- Quantify the possible changes from baseline related to the use of antithyroid drugs in mini mental health status in patients aged 65 or more, with the initial serum TSH at the lower limit of the normal range (1.0 mIU/ml)to values of TSH more than 2.0mUI/ml for six months.
Measured: six months
Assess the depression scale in seniors aged 65 years old or older, in different quartiles of normal range for serum TSH and these changes from baseline after use of methimazole
Describe the depression scale in elderly health population of 65 years old or more, in different quartiles of normal range for serum TSH.
- Assess the outcome in depression scale in seniors aged 65 olde or more, in different quartiles of normal range for serum TSH.
- Quantify the possible changes from baseline related to the use of antithyroid drugs in the depression scale in patients aged 65 years old or more, with the initial serum TSH at the lower limit of the normal range (1.0 mIU/ml)to values of TSH more than 2.0mUI/ml for six months..
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2013 (estimated)
- Study startSep 2011
- Primary completionJul 2014 (estimated)
- Study completionSep 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade Federal do Rio de Janeiro
- Sponsor type
- University, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Responsible party
- Principal investigator, Dhianah Santini de Oliveira Chachamovitz, Universidade Federal do Rio de Janeiro
- Investigators
- Dhiãnah SO Chachamovitz, Principal investigator, Universidade Federal do Rio de Janeiro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01849861
- Sponsor's protocol ID
- idosos01
- Status last verified
- May 2013
- First submitted
- 23 Apr 2013
- Last updated
- 13 May 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiopulmonary Capacity In Different Quartiles Ranges Of Reference For Serum Thyroid Stimulating Hormone (TSH): Sectional Evaluation And Effect Of The Use Of Methimazole In Elderly Population
- ClinicalTrials.gov ID
- NCT01849861
- Acronym / sponsor ID
- idosos01
- Conditions
- Healthy
- Keywords
- Cardiopulmonary Capacity, Ranges of TSH, Elderly Population
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Universidade Federal do Rio de JaneiroUniversity, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Study start
- Sep 2011
- Primary completion
- Jul 2014 (estimated)
- Study completion
- Sep 2014 (estimated)
- First posted
- 9 May 2013 (estimated)
- 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 purpose of this study is to correlate in an elderly population (≥ 65 years), the different levels of serum TSH, with cardiopulmonary capacity, quality of life, depressive symptoms and cognition. And assess whether the increased serum TSH to the upper half of the normal range, through the use of antithyroid drugs, is associated with improvements in these parameters.
Detailed description
Specific Objectives:
Describe the cardiopulmonary capacity in elderly people with 65 years old or more, in different quartiles of normal range for serum TSH.
Assess the quality of life, mini mental health status and depression scale in seniors aged 65 or older, in different quartiles of normal range for serum TSH.
Quantify the possible effects related to the use of antithyroid drugs in cardiopulmonary capacity, quality of life, mini mental health status and depression scale in elderly people aged 65 or more, with the initial serum TSH at the lower limit of the normal range (1.0 milli-International unit/ml) (mIU/ml).
Justification:
Despite evidence that in the elderly population the mean serum TSH tends to be higher as compared to younger adults, there isn't a curve of normal range of TSH for this specific population (more shifted to the right, which would increase the number of diagnoses for subclinical hyperthyroidism).
Thus, elderly individuals, even when classified as euthyroidism, but presenting TSH in the normal lower range, may present at a greater risk of cardiovascular disease and therefore, may have indication for treatment.
These findings motivate and justify this study design, which may have great clinical relevance in the scientific community for its originality, and important clinical applicability.
Materials and Methods:
If the patient agrees to participate, an appointment will be scheduled at HUCFF that will be made: anamnesis, review of medical records, clinical examination and signing the Informed Consent Form (ICF).
Secondly, they will be guided and directed to: laboratory analysis for serum dosage of TSH and free thyroxine (FT4), cardiopulmonary exercise testing and application of the questionnaires of quality of life, mini mental health status and depression.
The study comprised of two parts:
Phase 1: Sectional:
- Analysis of variables.
- Sample as a whole and according to the quartiles of the reference range for serum TSH, with comparisons between groups.
- 1st Quartile: TSH: 0.4 to 1.0 mIU / ml.
- 2nd Quartile: TSH: 1.0 to 2.0 mIU / ml.
- 3rd Quartile: TSH: 2.0 to 3.0 mIU / ml.
- 4th Quartile: TSH: 3.0 to 4.0 mIU / ml Phase 2: Clinical uncontrolled. Patients with serum TSH initially on the 1st. Quartile (TSH: 0.4 to 1.0 mIU / ml) will receive treatment with Methimazole (initial dose of 5mg/day) with the goal of raising the TSH values to range between 2.0 and 4.0 mIU / ml (the half upper range of normal).
After six months with TSH in the target range (2.0 and 4.0 mIU / ml), these patients will be subjected to the same examination protocol performed at baseline and assessed to the effects of treatment on outcome variables.
Variables considered in this study:
- TSH and FT4
- Questionnaire of Quality of life for older adults (WHOQOL-OLD)
- Mini-Mental State Examination
- Geriatric Depression Scale
- Cardiopulmonary exercise testing - cardiopulmonary capacity Variables to be analyzed at rest, peak of the exercise and recovery: Heart rate, systolic blood pressure and diastolic blood pressure.
Variables to be assessed at peak effort: pulmonary ventilation, oxygen consumption, carbon dioxide production, ventilatory equivalent for oxygen and carbon dioxide, respiratory quotient, oxygen pulse, fraction of expired oxygen and carbon dioxide.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Methimazole, | Experimental | Drug: MethimazolePatients with serum TSH initially on the 1st. Quartile (TSH: 0.4 to 1.0 mIU / ml) will receive treatment with Methimazole (initial dose of 5mg/day) with the goal of raising the TSH values to range between 2.0 and 4.0 mIU / ml (the half upper range of normal). After six months with TSH in the target range (2.0 and 4.0 mIU / ml), these patients will be subjected to the same examination protocol performed at baseline and assessed to the effects of treatment on outcome variables. Variables considered in this study: * TSH and FT4 * Questionnaire of Quality of life for older adults (WHOQOL-OLD) * Mini-Mental State Examination * Geriatric Depression Scale * Cardiopulmonary exercise testing - cardiopulmonary capacity |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Age ≥ 65 years.
- Healthy Men and women
- Registration at the University Hospital Clementino Fraga Filho (HUCFF).
Key exclusion criteria (7 listed)
- Hypothalamic-pituitary disease
- Congestive cardiac insufficiency, chronic renal failure, acute renal failure, stroke, chronic obstructive pulmonary disease, asthma, cancer and / or cirrhosis.
- Diseases of the aorta, peripheral vascular disease, coronary artery disease (including angina, history of prior myocardial infarction or angina, or history of cardiac catheterization and angioplasty).
- Use of corticosteroids, amiodarone or dopamine, as well as any drug that interferes with the levels of thyroid hormones and / or thyroid function.
- Use of drugs that interfere with autonomic adaptation mechanism, such as beta-blockers, prolopa and calcium channel blockers. Hypertensive patients without use of such drugs may be included.
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 |
|---|---|---|
| MethimazoleAlso: a single groupPatients with serum TSH initially on the 1st. Quartile (TSH: 0.4 to 1.0 mIU / ml) will receive treatment with Methimazole (initial dose of 5mg/day) with the goal of raising the TSH values to range between 2.0 and 4.0 mIU / ml (the half upper range of normal). After six months with TSH in the target range (2.0 and 4.0 mIU / ml), these patients will be subjected to the same examination protocol performed at baseline and assessed to the effects of treatment on outcome variables. Variables considered in this study: * TSH and FT4 * Questionnaire of Quality of life for older adults (WHOQOL-OLD) * Mini-Mental State Examination * Geriatric Depression Scale * Cardiopulmonary exercise testing - cardiopulmonary capacity | Drug | Methimazole, |
Primary outcome
Correlate in a population of more than 65 years old, the different levels of serum TSH, with cardiopulmonary capacity and these effects from baseline after treatment with antithyroid drugs
Time frame: six months
Describe the cardiopulmonary capacity in elderly health population of 65 years old or more, in different quartiles of normal range for serum TSH. * Assess the outcome in the cardiopulmonary capacity in seniors aged 65 years old or more, in different quartiles of normal range for serum TSH. * Quantify the possible changes from baseline related to the use of antithyroid drugs in cardiopulmonary capacity in patients aged 65 or more, with the initial serum TSH at the lower limit of the normal range (1.0 mIU/ml)to values of TSH more than 2.0mUI/ml for six months.
3 secondary outcomes
Assess the quality of life in seniors aged 65 years old or older, in different quartiles of normal range for serum TSH and these changes from baseline after use of methimazole
Time frame: six months
Assess the mini mental health status in seniors aged 65 years old or older, in different quartiles of normal range for serum TSH and these changes from baseline after use of methimazole
Time frame: six months
Assess the depression scale in seniors aged 65 years old or older, in different quartiles of normal range for serum TSH and these changes from baseline after use of methimazole
Time frame: six months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2013.
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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.
Dhiãnah SO Chachamovitz principal investigator
Universidade Federal do Rio de Janeiro
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 Methimazole in people with Healthy, run by Universidade Federal do Rio de Janeiro at 1 site in Brazil.
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 7 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: status not confirmed, as of the sponsor's last update on 13 May 2013. 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 Brazil. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dhiãnah SO Chachamovitz (+552126203063, dhianahsantini@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlate in a population of more than 65 years old, the different levels of serum TSH, with cardiopulmonary capacity and these effects from baseline after treatment with antithyroid drugs (time frame: six months). 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 13 May 2013.