Cardiopulmonary Capacity in Elderly With Different Ranges of Serum Thyroid Stimulating Hormone
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01849861 |
Recruitment Status : Unknown
Verified May 2013 by Dhianah Santini de Oliveira Chachamovitz, Universidade Federal do Rio de Janeiro.
Recruitment status was: Recruiting
First Posted : May 9, 2013
Last Update Posted : May 13, 2013
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Healthy | Drug: Methimazole | Phase 4 |

Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 200 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Diagnostic |
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 |
Study Start Date : | September 2011 |
Estimated Primary Completion Date : | July 2014 |
Estimated Study Completion Date : | September 2014 |

Arm | Intervention/treatment |
---|---|
Experimental: Methimazole,
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:
|
Drug: Methimazole
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:
Other Name: a single group |
- 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.
- 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 ]
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..
- 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 ]
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.
- 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 ]
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..

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 65 Years and older (Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Age ≥ 65 years.
- Healthy Men and women
- Registration at the University Hospital Clementino Fraga Filho (HUCFF).
Exclusion Criteria:
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01849861
Contact: Dhiãnah SO Chachamovitz | +552126203063 | dhianahsantini@gmail.com | |
Contact: Patrícia de Fátima S Teixeira | +552125622748 | pfatima@hucff.ufrj.br |
Brazil | |
Universidade Federal do Rio de Janeiro | Recruiting |
Rio de Janeiro, Brazil, 21941-590 | |
Contact: Dhiãnah SO Chachamovitz, MD +552126203063 dhianahsantini@gmail.com | |
Contact: Patrícia de Fátima S Teixeira, MD, PhD +552125622748 pfatima@hucff.ufrj.br | |
Principal Investigator: Dhiãnah SO Chachamovitz, MD |
Principal Investigator: | Dhiãnah SO Chachamovitz | Universidade Federal do Rio de Janeiro |
Responsible Party: | Dhianah Santini de Oliveira Chachamovitz, Principal Investigator, Universidade Federal do Rio de Janeiro |
ClinicalTrials.gov Identifier: | NCT01849861 |
Other Study ID Numbers: |
idosos01 |
First Posted: | May 9, 2013 Key Record Dates |
Last Update Posted: | May 13, 2013 |
Last Verified: | May 2013 |
Cardiopulmonary Capacity Ranges of TSH Elderly Population |
Methimazole Antithyroid Agents Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs |