Heart FailurePhase 4NCT01852994
Exercise Training and Testosterone Replacement in Heart Failure Patients
A Phase 4 study testing Testosterone replacement and Exercise training in people with Heart Failure, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial summary
The purpose of this study is to determine if exercise training with or without testosterone replacement can improve cardiopathy in heart failure patients Read more about this study
- Who is it for?
- Ages 18 to 65 years, men only
- Conditions the study is for
- Heart Failure
- What is being tested?
- Testosterone replacement and Exercise training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteBrazil
- Study dates
- Jul 2009to Jul 2015
- 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 65 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- heart failure
- hypogonadism
- left ventricular fraction ejection < 45%
Who cannot join
- chronic renal failure
- normal testosterone
- pace maker
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Instituto do Coração do Hospital da Clínicas da Universidade de Sao Paulo
São Paulo, São Paulo, 05403-900
About this study
The purpose of this study is to determine if exercise training with or without testosterone replacement can improve cardiopathy in heart failure patients
Read the detailed description
In this study, we are evaluating:
- hospital length of stay and readmission
- muscle sympathetic nerve activity
- functional capacity
- body composition
- Conditions
- Heart Failure
- Being tested
- Testosterone replacement, Exercise training
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Testosterone replacementDrug
Also called Testosterone Undecylate (Nebido)
Application quarterly of Testosterone Undecylate
Exercise trainingOther
Aerobic and strength exercise training
| Study group | Role | What they receive |
|---|---|---|
| Exercise training | Other | Aerobic and strength exercise training Receives: Other: Exercise training |
| Testosterone replacement | Other | Testosterone replacement will be done quarterly Receives: Drug: Testosterone replacement |
| Testosterone replacement+Exercise | Other | Both Testosterone replacement and Exercise will done Receives: Drug: Testosterone replacement; Other: Exercise training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Microneurography
Muscle sympathetic nerve activity (MSNA) is recorded directly from the peroneal nerve using the microneurography technique. Multiunit postganglionic muscle sympathetic nerve recordings is made using a tungsten microelectrode. All of the recordings of MSNA met previously established and described criteria. MSNA is quantified as burst frequency (bursts per minute).
Measured: 4 months of exercise training/testosterone replacement
Forearm blood flow
Forearm blood flow is measured by venous occlusion plethysmography. The nondominant arm is elevated above heart level to ensure adequate venous drainage. A mercury-filled silastic tube attached to a low-pressure transducer is placed around the forearm and connected to a plethysmography. Forearm blood flow is determined on the basis of a minimum off four separate readings. Forearm vascular conductance is calculated by dividing forearm blood flow by mean arterial pressure times 100 and expressed in arbitrary units.
Measured: 4 months of exercise training/testosterone replacement
Secondary outcomes (3)
Cardiopulmonary exercise
The maximal cardiopulmonary test is carried out on a bike using a ramp protocol with workload increment every minute with energetic demand of about 1 metabolic equivalent(MET) per minute or 3.5 mL/Kg.min of oxygen uptake.
Measured: 4 months of exercise training/testosterone replacement
Body composition
Body composition and bone mineral density is determined by dual energy x-ray absorptiometry using densitometry equipment (Hologic), at the following regions: lumbar spine, femoral neck, total femur and total body. Appendicular lean mass is calculated as the sum of arms and legs lean soft tissue masses, assuming that all non-fat and non-bone tissue is skeletal muscle. The total body fat is expressed in grams and as a percentage of body weight.
Measured: 4 months of exercise training/testosterone replacement
Muscle biopsy
The muscle biopsy is obtained with a single entry into the muscle 5-10 minutes after administering the local anesthetic following an incision through the skin. A portion of the muscle (~10 mg) is processed to evaluate 1) muscle fiber type and 2) cross-sectional area
Measured: 4 months of exercise training/testosterone replacement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2013 (estimated)
- Study startJul 2009
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies 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
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maria Janieire N Alves, MD; PhD, Principal investigator, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01852994
- Sponsor's protocol ID
- Testosterone
- Status last verified
- May 2013
- First submitted
- 11 Mar 2013
- Last updated
- 15 Dec 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise Training and Testosterone Replacement in Heart Failure Patients
- ClinicalTrials.gov ID
- NCT01852994
- Acronym / sponsor ID
- Testosterone
- Conditions
- Heart Failure
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Study start
- Jul 2009
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 14 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 determine if exercise training with or without testosterone replacement can improve cardiopathy in heart failure patients
Detailed description
In this study, we are evaluating:
- hospital length of stay and readmission
- muscle sympathetic nerve activity
- functional capacity
- body composition
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Exercise training | Other | Other: Exercise trainingAerobic and strength exercise training |
| Testosterone replacement | Other | Drug: Testosterone replacementTestosterone replacement will be done quarterly |
| Testosterone replacement+Exercise | Other | Drug: Testosterone replacement, Other: Exercise trainingBoth Testosterone replacement and Exercise will done |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- heart failure
- hypogonadism
- left ventricular fraction ejection < 45%
Key exclusion criteria (3 listed)
- chronic renal failure
- normal testosterone
- pace maker
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 |
|---|---|---|
| Testosterone replacementAlso: Testosterone Undecylate (Nebido)Application quarterly of Testosterone Undecylate | Drug | Testosterone replacement, Testosterone replacement+Exercise |
| Exercise trainingAerobic and strength exercise training | Other | Exercise training, Testosterone replacement+Exercise |
Primary outcome
Microneurography
Time frame: 4 months of exercise training/testosterone replacement
Muscle sympathetic nerve activity (MSNA) is recorded directly from the peroneal nerve using the microneurography technique. Multiunit postganglionic muscle sympathetic nerve recordings is made using a tungsten microelectrode. All of the recordings of MSNA met previously established and described criteria. MSNA is quantified as burst frequency (bursts per minute).
Forearm blood flow
Time frame: 4 months of exercise training/testosterone replacement
Forearm blood flow is measured by venous occlusion plethysmography. The nondominant arm is elevated above heart level to ensure adequate venous drainage. A mercury-filled silastic tube attached to a low-pressure transducer is placed around the forearm and connected to a plethysmography. Forearm blood flow is determined on the basis of a minimum off four separate readings. Forearm vascular conductance is calculated by dividing forearm blood flow by mean arterial pressure times 100 and expressed in arbitrary units.
3 secondary outcomes
Cardiopulmonary exercise
Time frame: 4 months of exercise training/testosterone replacement
Body composition
Time frame: 4 months of exercise training/testosterone replacement
Muscle biopsy
Time frame: 4 months of exercise training/testosterone replacement
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 15 Dec 2016.
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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.
Maria Janieire N Alves, MD; PhD principal investigator
University of Sao Paulo
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 Testosterone replacement and Exercise training in people with Heart Failure, run by University of Sao Paulo General Hospital 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 3 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 15 Dec 2016. 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?
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?
Microneurography (time frame: 4 months of exercise training/testosterone replacement). The study lists 2 primary outcomes in all. 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 15 Dec 2016.