Heart FailureTestoHFNCT03463226
Effects of Hormonal Anabolic Deficiency and Neurovascular Alterations on Mortality in Male Patients With Heart Failure
An observational study of Heart Failure, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial summary
Heart failure (HF) has been associated with chronic deleterious effects on skeletal muscle, endocrine system, vasculature and sympathetic nervous system. These alterations have a significant impact on quality of life, leading to a reduction in functional capacity and limited symptoms, which involve dyspnea and… 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?
- Cardiopulmonary exercise test, Muscle Sympathetic Nerve Activity and Dual-energy X-ray absorptiometry
- How many people
- 169 participants
- Where
- 1 siteBrazil
- Study dates
- 30 Jun 2016to 30 Dec 2020
- Phase
- Observational
- 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
Study population: Patients with heart failure recruited at Clinical Unit of Myocardiopathy at General Hospital of the University of São Paulo Medical School (UNCAR/HC-FMUSP).
Who may be able to join
- age between 18 and 65 years old;
- at least1 year of diagnosed HF;
- left ventricular ejection fraction (LVEF) lower than 40% measured by echocardiography;
- non-ischaemic and ischaemic aetiologies;
- compensated HF with optimal medication for at least 3 months prior the study;
- New York Heart Association (NYHA) class of I to IV.
Who cannot join
- patients with autonomic diabetic neuropathy;
- patients with chronic renal failure with haemodialysis;
- heart transplantation;
- presence of pacemaker;
- patients with muscular dystrophy (i.e. Duchenne muscular dystrophy);
- patients submitted to any hormonal treatment;
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- history of cancer;
- ongoing infection;
- myocardial infarction with percutaneous coronary intervention or revascularization 6 months prior to the study entry.
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
Official title: Hormonal Anabolic Deficiency Associated With Neurovascular Alterations Predict Poor Prognosis in Male Patients With Heart Failure
Heart failure (HF) has been associated with chronic deleterious effects on skeletal muscle, endocrine system, vasculature and sympathetic nervous system. These alterations have a significant impact on quality of life, leading to a reduction in functional capacity and limited symptoms, which involve dyspnea and fatigue. The investigators tested the hypothesis that hormonal anabolic deficiency associated with neurovascular alterations may worsen the prognosis of patients with heart failure.
Read the detailed description
One hundred and fifty six patients have been enrolled so far. Methods were as described below:
- Muscle sympathetic nerve activity (MSNA) was directly recorded from the peroneal nerve using the microneurography technique ;
- All patients underwent symptom-limited cardiopulmonary exercise test performed on a cycle ergometer, using a ramp protocol with workload increments of 5 or 10 Watts per minute;
- Body composition measurements were performed using dual-energy X-ray absorptiometry (DXA);
- Muscle strength was assessed by handgrip dynamometer using the mean value of three attempts;
- Blood samples were drawn in the morning after 12h overnight fasting. The laboratory tests included B-type natriuretic peptide (BNP; pg/mL) plasma level, serum sodium (mEq/L), serum potassium (mEq/L), creatinine (mg/dL), haemoglobin level (g/dL), high-sensitivity C-reactive protein (CRP; mg/L), lipid profile (triglyceride, total cholesterol, high-density lipoprotein, and low-density lipoprotein; mg/dL), and fasting glucose (mg/dL). Blood sample to assess hormone plasma levels were also drawn at the same time: total testosterone (TT), free testosterone (FT), sex hormone binding globulin (SHBG), dehydroepiandrosterone sulfate (DHEAS), luteinizing hormone (LH), follicle-stimulating hormone (FSH), thyroid stimulating hormone (TSH) and insulin-like growth factor 1 (IGF1).
- Conditions
- Heart Failure
- Being tested
- Cardiopulmonary exercise test, Muscle Sympathetic Nerve Activity, Dual-energy X-ray absorptiometry, Venous occlusion plethysmography, Blood sample collection
- Keywords
- Testosterone Deficiency, Sympathetic overactivity, Exercise Intolerance
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiopulmonary exercise testDiagnostic test
Oxygen consumption (VO2) and carbon dioxide output (VCO2) were measured by means of gas exchange on a breath-by-breath basis. The patients were initially monitored for 2 minutes at rest when seated on the ergometer, after that they were instructed to pedal at a pace of 60-70 rpm and the completion of the test occurred when, in spite of verbal encouragement, the patient reached maximal volitional fatigue.
Muscle Sympathetic Nerve ActivityDiagnostic test
Multiunit post-ganglionic muscle sympathetic nerve recordings were made using a tungsten microelectrode placed in the peroneal nerve near the fibular head. Nerve signals were amplified by a factor of 50,000 to 100,000 and band-pass filtered (700 to 2000 Hz). For recording and analysis, nerve activity was rectified and integrated (time constant 0.1 seconds) to obtain a mean voltage display of sympathetic nerve activity.
Dual-energy X-ray absorptiometryDiagnostic test
Dual-energy X-ray absorptiometry (DXA) scan was used to measure total lean mass, body fat and bone mineral content.
Venous occlusion plethysmographyDiagnostic test
Venous occlusion plethysmography was used to assess non-invasively blood flow.
Blood sample collectionDiagnostic test
Blood samples were drawn in the morning after 12h overnight fasting.
Dynamometers for Handgrip StrengthDiagnostic test
Muscle strength was assessed by handgrip dynamometer using the mean value of three attempts.
| Study group | Role | What they receive |
|---|---|---|
| Low testosterone | Patients with HF and testosterone deficiency.
* Cardiopulmonary exercise test
* Muscle Sympathetic Nerve Activity
* Dual-energy X-ray absorptiometry
* Venous occlusion plethysmography
* Blood sample collection
* Dynamometers for Handgrip Strength Receives: Diagnostic Test: Cardiopulmonary exercise test; Diagnostic Test: Muscle Sympathetic Nerve Activity; Diagnostic Test: Dual-energy X-ray absorptiometry; Diagnostic Test: Venous occlusion plethysmography; Diagnostic Test: Blood sample collection; Diagnostic Test: Dynamometers for Handgrip Strength | |
| Normal testosterone | Patients with HF and normal plasma levels of testosterone.
* Cardiopulmonary exercise test
* Muscle Sympathetic Nerve Activity
* Dual-energy X-ray absorptiometry
* Venous occlusion plethysmography
* Blood sample collection
* Dynamometers for Handgrip Strength Receives: Diagnostic Test: Cardiopulmonary exercise test; Diagnostic Test: Muscle Sympathetic Nerve Activity; Diagnostic Test: Dual-energy X-ray absorptiometry; Diagnostic Test: Venous occlusion plethysmography; Diagnostic Test: Blood sample collection; Diagnostic Test: Dynamometers for Handgrip Strength |
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact of testosterone deficiency on mortality
Blood sample was collected in the morning (between 8:00-10:00 a.m.) after 12 hours fasting.
Measured: 2 years
Impact of muscle sympathetic nerve activity on mortality
Microneurography was used to assess the sympathetic nervous system.
Measured: 2 years
Impact of neurovascular alterations on mortality
Venous occlusion pletysmography was used to evaluate vasodilation.
Measured: 2 years
Secondary outcomes (3)
Impact of testosterone deficiency on body composition
Body composition measurements were performed using dual-energy X-ray absorptiometry.
Measured: 2 years
Impact of testosterone deficiency on functional capacity
All patients underwent symptom-limited cardiopulmonary exercise test to measure functional capacity.
Measured: 2 years
Impact of testosterone deficiency on strength
Muscle strength was assessed by handgrip dynamometer using the mean value of three attempts.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2018
- Study start30 Jun 2016
- Primary completion23 Mar 2020
- Study completion30 Dec 2020
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.
- More trials run by University of Sao Paulo General HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 169 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Responsible party
- Principal investigator, Maria Janieire de Nazaré Nunes Alves, University of Sao Paulo General Hospital
- Investigators
- Maria Janieire de Nazaré Nunes Alves, PhD, Principal investigator, InCor Heart Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03463226
- Sponsor's protocol ID
- AnabolicHormonesPrognosis
- Acronym
- TestoHF
- Status last verified
- Apr 2021
- First submitted
- 1 Mar 2018
- Last updated
- 3 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hormonal Anabolic Deficiency Associated With Neurovascular Alterations Predict Poor Prognosis in Male Patients With Heart Failure
- ClinicalTrials.gov ID
- NCT03463226
- Acronym / sponsor ID
- TestoHF / AnabolicHormonesPrognosis
- Conditions
- Heart Failure
- Keywords
- Testosterone Deficiency, Sympathetic overactivity, Exercise Intolerance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 169 participants (actual)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Study start
- 30 Jun 2016 (actual)
- Primary completion
- 23 Mar 2020 (actual)
- Study completion
- 30 Dec 2020 (actual)
- First posted
- 13 Mar 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.
Heart failure (HF) has been associated with chronic deleterious effects on skeletal muscle, endocrine system, vasculature and sympathetic nervous system. These alterations have a significant impact on quality of life, leading to a reduction in functional capacity and limited symptoms, which involve dyspnea and fatigue. The investigators tested the hypothesis that hormonal anabolic deficiency associated with neurovascular alterations may worsen the prognosis of patients with heart failure.
Detailed description
One hundred and fifty six patients have been enrolled so far. Methods were as described below:
- Muscle sympathetic nerve activity (MSNA) was directly recorded from the peroneal nerve using the microneurography technique ;
- All patients underwent symptom-limited cardiopulmonary exercise test performed on a cycle ergometer, using a ramp protocol with workload increments of 5 or 10 Watts per minute;
- Body composition measurements were performed using dual-energy X-ray absorptiometry (DXA);
- Muscle strength was assessed by handgrip dynamometer using the mean value of three attempts;
- Blood samples were drawn in the morning after 12h overnight fasting. The laboratory tests included B-type natriuretic peptide (BNP; pg/mL) plasma level, serum sodium (mEq/L), serum potassium (mEq/L), creatinine (mg/dL), haemoglobin level (g/dL), high-sensitivity C-reactive protein (CRP; mg/L), lipid profile (triglyceride, total cholesterol, high-density lipoprotein, and low-density lipoprotein; mg/dL), and fasting glucose (mg/dL). Blood sample to assess hormone plasma levels were also drawn at the same time: total testosterone (TT), free testosterone (FT), sex hormone binding globulin (SHBG), dehydroepiandrosterone sulfate (DHEAS), luteinizing hormone (LH), follicle-stimulating hormone (FSH), thyroid stimulating hormone (TSH) and insulin-like growth factor 1 (IGF1).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low testosterone | – | Diagnostic Test: Cardiopulmonary exercise test, Diagnostic Test: Muscle Sympathetic Nerve Activity, Diagnostic Test: Dual-energy X-ray absorptiometry, Diagnostic Test: Venous occlusion plethysmography, Diagnostic Test: Blood sample collection, Diagnostic Test: Dynamometers for Handgrip StrengthPatients with HF and testosterone deficiency. * Cardiopulmonary exercise test * Muscle Sympathetic Nerve Activity * Dual-energy X-ray absorptiometry * Venous occlusion plethysmography * Blood sample collection * Dynamometers for Handgrip Strength |
| Normal testosterone | – | Diagnostic Test: Cardiopulmonary exercise test, Diagnostic Test: Muscle Sympathetic Nerve Activity, Diagnostic Test: Dual-energy X-ray absorptiometry, Diagnostic Test: Venous occlusion plethysmography, Diagnostic Test: Blood sample collection, Diagnostic Test: Dynamometers for Handgrip StrengthPatients with HF and normal plasma levels of testosterone. * Cardiopulmonary exercise test * Muscle Sympathetic Nerve Activity * Dual-energy X-ray absorptiometry * Venous occlusion plethysmography * Blood sample collection * Dynamometers for Handgrip Strength |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with heart failure recruited at Clinical Unit of Myocardiopathy at General Hospital of the University of São Paulo Medical School (UNCAR/HC-FMUSP).
Key inclusion criteria (6 listed)
- age between 18 and 65 years old;
- at least1 year of diagnosed HF;
- left ventricular ejection fraction (LVEF) lower than 40% measured by echocardiography;
- non-ischaemic and ischaemic aetiologies;
- compensated HF with optimal medication for at least 3 months prior the study;
Key exclusion criteria (9 listed)
- patients with autonomic diabetic neuropathy;
- patients with chronic renal failure with haemodialysis;
- heart transplantation;
- presence of pacemaker;
- patients with muscular dystrophy (i.e. Duchenne muscular dystrophy);
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 |
|---|---|---|
| Cardiopulmonary exercise testOxygen consumption (VO2) and carbon dioxide output (VCO2) were measured by means of gas exchange on a breath-by-breath basis. The patients were initially monitored for 2 minutes at rest when seated on the ergometer, after that they were instructed to pedal at a pace of 60-70 rpm and the completion of the test occurred when, in spite of verbal encouragement, the patient reached maximal volitional fatigue. | Diagnostic test | Low testosterone, Normal testosterone |
| Muscle Sympathetic Nerve ActivityMultiunit post-ganglionic muscle sympathetic nerve recordings were made using a tungsten microelectrode placed in the peroneal nerve near the fibular head. Nerve signals were amplified by a factor of 50,000 to 100,000 and band-pass filtered (700 to 2000 Hz). For recording and analysis, nerve activity was rectified and integrated (time constant 0.1 seconds) to obtain a mean voltage display of sympathetic nerve activity. | Diagnostic test | Low testosterone, Normal testosterone |
| Dual-energy X-ray absorptiometryDual-energy X-ray absorptiometry (DXA) scan was used to measure total lean mass, body fat and bone mineral content. | Diagnostic test | Low testosterone, Normal testosterone |
| Venous occlusion plethysmographyVenous occlusion plethysmography was used to assess non-invasively blood flow. | Diagnostic test | Low testosterone, Normal testosterone |
| Blood sample collectionBlood samples were drawn in the morning after 12h overnight fasting. | Diagnostic test | Low testosterone, Normal testosterone |
| Dynamometers for Handgrip StrengthMuscle strength was assessed by handgrip dynamometer using the mean value of three attempts. | Diagnostic test | Low testosterone, Normal testosterone |
Primary outcome
Impact of testosterone deficiency on mortality
Time frame: 2 years
Blood sample was collected in the morning (between 8:00-10:00 a.m.) after 12 hours fasting.
Impact of muscle sympathetic nerve activity on mortality
Time frame: 2 years
Microneurography was used to assess the sympathetic nervous system.
Impact of neurovascular alterations on mortality
Time frame: 2 years
Venous occlusion pletysmography was used to evaluate vasodilation.
3 secondary outcomes
Impact of testosterone deficiency on body composition
Time frame: 2 years
Impact of testosterone deficiency on functional capacity
Time frame: 2 years
Impact of testosterone deficiency on strength
Time frame: 2 years
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 3 May 2021.
- Individual participant dataSharing planned: No
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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 de Nazaré Nunes Alves, PhD principal investigator
InCor Heart Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of 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 6 inclusion and 9 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 3 May 2021. 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.
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?
Impact of testosterone deficiency on mortality (time frame: 2 years). The study lists 3 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 3 May 2021.