Heart FailurePhase 4TICNCT01813201
Benefit of the Treatment With Testosterone in Chronic Heart Failure Testosterone Deficiency Subjects
A Phase 4 study testing Testosterone undecanoate and Saline isotonic solution in people with Heart Failure, run by Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia at 1 site in Spain.
Trial summary
The purpose of this clinical trial is to determine whether intermittent administration of testosterone against placebo is associated with a reduction of mortality and heart failure hospitalizations at 1 year, in male patients with advanced heart failure and testosterone deficiency. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Heart Failure
- What is being tested?
- Testosterone undecanoate and Saline isotonic solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 14 participants
- Where
- 1 siteSpain
- Study dates
- Mar 2011to Mar 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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least one hospital admission for HF.
- Stable clinical status, New York Heart Association (NYHA) functional class II-IV.
- Left ventricular ejection fraction of less than 40%
- NT-proBNP concentration greater than 1000 pg / ml.
- Total testosterone and free testosterone deficiency measured in the last month
- Age >18 years.
- Patients who have given their written informed consent.
Who cannot join
- No informed consent.
- Taking oral anticoagulants
- Severe valvular heart disease with an indication for surgical repair.
- Extracardiac disease with an estimated prognosis of less than 1 year.
- History of androgen-dependent prostate cancer, benign prostate hyperplasia treatment or prostate-specific antigen (PSA)> 3 ng / ml.
- History of breast carcinoma or liver tumor
Show all 12Show fewer
- Severe renal impairment (glomerular filtration rate <30 ml / kg / min).
- Acute coronary syndrome in the last year
- Renal or hepatic failure
- Uncontrolled hypertension
- Erythrocytosis (hematocrit> 5%)
- Hypersensitivity to testosterone or any excipients.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Cardiology Service, Hospital Universitario Virgen de la Arrixaca
Murcia, 30120
About this study
Official title: A Randomized and Double-blind Study to Evaluate the Benefit of the Treatment With Testosterone in Chronic Heart Failure Testosterone Deficiency Subjects
The purpose of this clinical trial is to determine whether intermittent administration of testosterone against placebo is associated with a reduction of mortality and heart failure hospitalizations at 1 year, in male patients with advanced heart failure and testosterone deficiency.
Read the detailed description
Heart Failure (HF) represents one of the major social and health problems, for its high prevalence and its huge economic impact, as well as the elevated morbidity and mortality associated. In Spain, the estimated prevalence is 7% over 45 years old, and it increases until 18% over 75 years old. Currently, HF is the leading cause of hospital admission over 65 years and the mortality for patients with symptomatic HF remains worse than the majority of cancers. The estimated minimum expenditure is 1.1% of total health care costs and 2% of specialized medical care. This accounts for a staggeringly large financial burden on the health care system.
Chronic HF is a complex disease, whose progression involves multiple pathophysiological systems. It is well established the deleterious effect of activation of renin-angiotensin-aldosterone and sympathetic nervous systems. The blockage of these systems by beta-blockers, angiotensin converting enzyme (ACE) inhibitors, angiotensin-receptor blockers (ARBs) and aldosterone antagonists has improved prognosis. However, in spite of these therapies, the prognosis of patients with chronic HF remains poor.
During the HF progression to advanced stages, it has been shown an anabolic and metabolic deterioration, resulting in a predominance of catabolic processes. The deficiency of anabolic hormones correlates with greater severity of symptoms, activation of neuroendocrine and inflammatory systems, insulin resistance, metabolic impairment, exercise intolerance, anemia and cardiac cachexia. All these processes take part of the final progression of the HF disease until death, when HF becomes a systemic disease. In men with HF, levels of testosterone (the main anabolic hormone) are decreased; in fact, 30% of men have levels below the 10th percentile of a reference healthy population adjusted for age. The deterioration of anabolic hormones correlates inversely with the severity of HF disease and it determines a higher mortality. In fact, low testosterone levels are associated with reduced cardiac output, greater symptomatic limitation and higher mortality. Therefore, testosterone deficiency in men with HF has a detrimental impact on symptoms and prognosis.
In addition, testosterone has shown to have beneficial effects on HF patients, such as vasodilatation of coronary and peripheral arteries, inotropic effects, reduction of neurohormonal activation, anti-inflammatory and immunomodulatory actions, reduction of cytokine production and improvement of muscle strength. All these actions have a potential benefit in patients with HF, because they are involved in the progression of the disease, especially at advanced stages.
The rational approach "testosterone replacement for improving the prognosis of patients with advanced HF and testosterone deficiency" has strong pathophysiological plausibility. To date, no other clinical trials have evaluated the effect of testosterone replacement on morbidity and mortality.
However, in the last years, numerous editorials in leading journals have concluded on the need to clarify the effect of testosterone therapy on cardiac function and the morbimortality in patients with advanced HF.
Our group has worked in the last years in this field, confirming the presence of a testosterone deficiency in men with chronic HF, which is associated with a worse prognosis and a greater decline in exercise capacity.
Therefore, the investigators propose a clinical trial of morbimortality in a population with advanced heart failure and associated deficiency on testosterone; in which, the previous background justifies the potential benefit of testosterone replacement therapy. In addition, the large clinical impact of this disease supports the priority need of an independent study.
- Conditions
- Heart Failure
- Being tested
- Testosterone undecanoate, Saline isotonic solution
- Keywords
- Testosterone, Anabolic deterioration
- 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 undecanoateDrug
Also called Reandron®
Testosterone undecanoate intramuscular long-acting, 1000 mg/dose, administered at inclusion and every 12 weeks for 9 months (4 dose) (testosterone group) against the administration of placebo (saline isotonic solution).
Saline isotonic solutionDrug
Saline isotonic solution (placebo)intramuscular,administered at inclusion and every 12 weeks for 9 months (4 dose)
| Study group | Role | What they receive |
|---|---|---|
| Testosterone undecanoate | Active comparator | Testosterone undecanoate intramuscular long-acting, 1000 mg/dose, administered at inclusion and every 12 weeks for 9 months (4 dose) Receives: Drug: Testosterone undecanoate |
| Saline isotonic solution (Placebo) | Placebo comparator | Placebo (saline isotonic solution)administered at inclusion and every 12 weeks for 9 months (4 dose) (control group). Receives: Drug: Saline isotonic solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Death
Death from any cause or hospitalization for heart failure or decompensation of heart failure requiring intravenous drug for stabilization.
Measured: 1 year
Secondary outcomes (5)
Mortality
Mortality from cardiovascular causes, for HF and other causes.
Measured: 1 year
Hospital readmissions for any reason.
Measured: 1 year
Number of decompensated heart failure who have required intravenous medication for stabilization.
Measured: 1 year
Changes in test quality of life (Minnesota Living Heart Failure) and clinical modified Framingham score.
Measured: 1 year
Changes in cardiac function parameters assessed by echocardiography and natriuretic peptide (NT)-proBNP concentration.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2013 (estimated)
- Study startMar 2011
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- 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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Universitario Virgen de la Arrixaca, Germans Trias i Pujol Hospital
- Responsible party
- Sponsor
- Investigators
- Domingo A Pascual-Figal, MD, PhD, Principal investigator, Hospital Universitario Virgen ArrixacaAntoni Bayes-Genis, MD, PhD, Principal investigator, Germans Trias i Pujol Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01813201
- Sponsor's protocol ID
- TIC-0911
- Other IDs
- 2009-016498-13, 2009
- Acronym
- TIC
- Status last verified
- Nov 2014
- First submitted
- 22 Jun 2011
- Last updated
- 13 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Rodriguez-Artalejo F, Banegas Banegas JR, Guallar-Castillon P. [Epidemiology of heart failure]. Rev Esp Cardiol. 2004 Feb;57(2):163-70. Spanish.
PubMed 14967113Bristow MR, Saxon LA, Boehmer J, Krueger S, Kass DA, De Marco T, Carson P, DiCarlo L, DeMets D, White BG, DeVries DW, Feldman AM; Comparison of Medical Therapy, Pacing, and Defibrillation in Heart Failure (COMPANION) Investigators. Cardiac-resynchronization therapy with or without an implantable defibrillator in advanced chronic heart failure. N Engl J Med. 2004 May 20;350(21):2140-50. doi: 10.1056/NEJMoa032423.
PubMed 15152059Pugh PJ, English KM, Jones TH, Channer KS. Testosterone: a natural tonic for the failing heart? QJM. 2000 Oct;93(10):689-94. doi: 10.1093/qjmed/93.10.689. No abstract available.
PubMed 11029481Malkin C, Jones T, Channer K. Testosterone in chronic heart failure. Front Horm Res. 2009;37:183-196. doi: 10.1159/000176053.
PubMed 19011297Pugh PJ, Jones RD, Jones TH, Channer KS. Heart failure as an inflammatory condition: potential role for androgens as immune modulators. Eur J Heart Fail. 2002 Dec;4(6):673-80. doi: 10.1016/s1388-9842(02)00162-9.
PubMed 12453536Anker SD, Al-Nasser FO. Chronic heart failure as a metabolic disorder. Heart Fail Monit. 2000;1(2):42-9.
PubMed 12634873Anker SD, Chua TP, Ponikowski P, Harrington D, Swan JW, Kox WJ, Poole-Wilson PA, Coats AJ. Hormonal changes and catabolic/anabolic imbalance in chronic heart failure and their importance for cardiac cachexia. Circulation. 1997 Jul 15;96(2):526-34. doi: 10.1161/01.cir.96.2.526.
PubMed 9244221Kontoleon PE, Anastasiou-Nana MI, Papapetrou PD, Alexopoulos G, Ktenas V, Rapti AC, Tsagalou EP, Nanas JN. Hormonal profile in patients with congestive heart failure. Int J Cardiol. 2003 Feb;87(2-3):179-83. doi: 10.1016/s0167-5273(02)00212-7.
PubMed 12559538Moriyama Y, Yasue H, Yoshimura M, Mizuno Y, Nishiyama K, Tsunoda R, Kawano H, Kugiyama K, Ogawa H, Saito Y, Nakao K. The plasma levels of dehydroepiandrosterone sulfate are decreased in patients with chronic heart failure in proportion to the severity. J Clin Endocrinol Metab. 2000 May;85(5):1834-40. doi: 10.1210/jcem.85.5.6568.
PubMed 10843161Jankowska EA, Biel B, Majda J, Szklarska A, Lopuszanska M, Medras M, Anker SD, Banasiak W, Poole-Wilson PA, Ponikowski P. Anabolic deficiency in men with chronic heart failure: prevalence and detrimental impact on survival. Circulation. 2006 Oct 24;114(17):1829-37. doi: 10.1161/CIRCULATIONAHA.106.649426. Epub 2006 Oct 9.
PubMed 17030678Jankowska EA, Filippatos G, Ponikowska B, Borodulin-Nadzieja L, Anker SD, Banasiak W, Poole-Wilson PA, Ponikowski P. Reduction in circulating testosterone relates to exercise capacity in men with chronic heart failure. J Card Fail. 2009 Jun;15(5):442-50. doi: 10.1016/j.cardfail.2008.12.011. Epub 2009 Feb 10.
PubMed 19477405P Peñafiel, DA Pascual, B. Redondo, P Nicolas, PL Tornel, J Sanchez-Mas, G de la Morena, M Valdés. Anabolic deficiency as determinant of functional impairment and prognosis in heart failure patients. European journal of Heart Failure 2007;6(supl 1):146.
Pugh PJ, Jones TH, Channer KS. Acute haemodynamic effects of testosterone in men with chronic heart failure. Eur Heart J. 2003 May;24(10):909-15. doi: 10.1016/s0195-668x(03)00083-6.
PubMed 12714022Malkin CJ, Jones TH, Channer KS. The effect of testosterone on insulin sensitivity in men with heart failure. Eur J Heart Fail. 2007 Jan;9(1):44-50. doi: 10.1016/j.ejheart.2006.04.006. Epub 2006 Jul 7.
PubMed 16828341Rauchhaus M, Doehner W, Anker SD. Heart failure therapy: testosterone replacement and its implications. Eur Heart J. 2006 Jan;27(1):10-2. doi: 10.1093/eurheartj/ehi653. Epub 2005 Nov 16. No abstract available.
PubMed 16291772
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized and Double-blind Study to Evaluate the Benefit of the Treatment With Testosterone in Chronic Heart Failure Testosterone Deficiency Subjects
- ClinicalTrials.gov ID
- NCT01813201
- Acronym / sponsor ID
- TIC / TIC-0911
- Conditions
- Heart Failure
- Keywords
- Testosterone, Anabolic deterioration
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Fundacion para la Formacion e Investigacion Sanitarias de la Region de MurciaUniversity, hospital or other
- Collaborators
- Hospital Universitario Virgen de la Arrixaca, Germans Trias i Pujol Hospital
- Study start
- Mar 2011 (actual)
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 18 Mar 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 clinical trial is to determine whether intermittent administration of testosterone against placebo is associated with a reduction of mortality and heart failure hospitalizations at 1 year, in male patients with advanced heart failure and testosterone deficiency.
Detailed description
Heart Failure (HF) represents one of the major social and health problems, for its high prevalence and its huge economic impact, as well as the elevated morbidity and mortality associated. In Spain, the estimated prevalence is 7% over 45 years old, and it increases until 18% over 75 years old. Currently, HF is the leading cause of hospital admission over 65 years and the mortality for patients with symptomatic HF remains worse than the majority of cancers. The estimated minimum expenditure is 1.1% of total health care costs and 2% of specialized medical care. This accounts for a staggeringly large financial burden on the health care system.
Chronic HF is a complex disease, whose progression involves multiple pathophysiological systems. It is well established the deleterious effect of activation of renin-angiotensin-aldosterone and sympathetic nervous systems. The blockage of these systems by beta-blockers, angiotensin converting enzyme (ACE) inhibitors, angiotensin-receptor blockers (ARBs) and aldosterone antagonists has improved prognosis. However, in spite of these therapies, the prognosis of patients with chronic HF remains poor.
During the HF progression to advanced stages, it has been shown an anabolic and metabolic deterioration, resulting in a predominance of catabolic processes. The deficiency of anabolic hormones correlates with greater severity of symptoms, activation of neuroendocrine and inflammatory systems, insulin resistance, metabolic impairment, exercise intolerance, anemia and cardiac cachexia. All these processes take part of the final progression of the HF disease until death, when HF becomes a systemic disease. In men with HF, levels of testosterone (the main anabolic hormone) are decreased; in fact, 30% of men have levels below the 10th percentile of a reference healthy population adjusted for age. The deterioration of anabolic hormones correlates inversely with the severity of HF disease and it determines a higher mortality. In fact, low testosterone levels are associated with reduced cardiac output, greater symptomatic limitation and higher mortality. Therefore, testosterone deficiency in men with HF has a detrimental impact on symptoms and prognosis.
In addition, testosterone has shown to have beneficial effects on HF patients, such as vasodilatation of coronary and peripheral arteries, inotropic effects, reduction of neurohormonal activation, anti-inflammatory and immunomodulatory actions, reduction of cytokine production and improvement of muscle strength. All these actions have a potential benefit in patients with HF, because they are involved in the progression of the disease, especially at advanced stages.
The rational approach "testosterone replacement for improving the prognosis of patients with advanced HF and testosterone deficiency" has strong pathophysiological plausibility. To date, no other clinical trials have evaluated the effect of testosterone replacement on morbidity and mortality.
However, in the last years, numerous editorials in leading journals have concluded on the need to clarify the effect of testosterone therapy on cardiac function and the morbimortality in patients with advanced HF.
Our group has worked in the last years in this field, confirming the presence of a testosterone deficiency in men with chronic HF, which is associated with a worse prognosis and a greater decline in exercise capacity.
Therefore, the investigators propose a clinical trial of morbimortality in a population with advanced heart failure and associated deficiency on testosterone; in which, the previous background justifies the potential benefit of testosterone replacement therapy. In addition, the large clinical impact of this disease supports the priority need of an independent study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Testosterone undecanoate | Active comparator | Drug: Testosterone undecanoateTestosterone undecanoate intramuscular long-acting, 1000 mg/dose, administered at inclusion and every 12 weeks for 9 months (4 dose) |
| Saline isotonic solution (Placebo) | Placebo comparator | Drug: Saline isotonic solutionPlacebo (saline isotonic solution)administered at inclusion and every 12 weeks for 9 months (4 dose) (control group). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- At least one hospital admission for HF.
- Stable clinical status, New York Heart Association (NYHA) functional class II-IV.
- Left ventricular ejection fraction of less than 40%
- NT-proBNP concentration greater than 1000 pg / ml.
- Total testosterone and free testosterone deficiency measured in the last month
Key exclusion criteria (12 listed)
- No informed consent.
- Taking oral anticoagulants
- Severe valvular heart disease with an indication for surgical repair.
- Extracardiac disease with an estimated prognosis of less than 1 year.
- History of androgen-dependent prostate cancer, benign prostate hyperplasia treatment or prostate-specific antigen (PSA)> 3 ng / ml.
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 undecanoateAlso: Reandron®Testosterone undecanoate intramuscular long-acting, 1000 mg/dose, administered at inclusion and every 12 weeks for 9 months (4 dose) (testosterone group) against the administration of placebo (saline isotonic solution). | Drug | Testosterone undecanoate |
| Saline isotonic solutionSaline isotonic solution (placebo)intramuscular,administered at inclusion and every 12 weeks for 9 months (4 dose) | Drug | Saline isotonic solution (Placebo) |
Primary outcome
Death
Time frame: 1 year
Death from any cause or hospitalization for heart failure or decompensation of heart failure requiring intravenous drug for stabilization.
5 secondary outcomes
Mortality
Time frame: 1 year
Hospital readmissions for any reason.
Time frame: 1 year
Number of decompensated heart failure who have required intravenous medication for stabilization.
Time frame: 1 year
Changes in test quality of life (Minnesota Living Heart Failure) and clinical modified Framingham score.
Time frame: 1 year
Changes in cardiac function parameters assessed by echocardiography and natriuretic peptide (NT)-proBNP concentration.
Time frame: 1 year
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 13 Dec 2017.
- Background: PubMed 14967113Rodriguez-Artalejo F, Banegas Banegas JR, Guallar-Castillon P. [Epidemiology of heart failure]. Rev Esp Cardiol. 2004 Feb;57(2):163-70. Spanish.
- Background: PubMed 15152059Bristow MR, Saxon LA, Boehmer J, Krueger S, Kass DA, De Marco T, Carson P, DiCarlo L, DeMets D, White BG, DeVries DW, Feldman AM; Comparison of Medical Therapy, Pacing, and Defibrillation in Heart Failure (COMPANION) Investigators. Cardiac-resynchronization therapy with or without an implantable defibrillator in advanced chronic heart failure. N Engl J Med. 2004 May 20;350(21):2140-50. doi: 10.1056/NEJMoa032423.
- Background: PubMed 11029481Pugh PJ, English KM, Jones TH, Channer KS. Testosterone: a natural tonic for the failing heart? QJM. 2000 Oct;93(10):689-94. doi: 10.1093/qjmed/93.10.689. No abstract available.
- Background: PubMed 19011297Malkin C, Jones T, Channer K. Testosterone in chronic heart failure. Front Horm Res. 2009;37:183-196. doi: 10.1159/000176053.
- Background: PubMed 12453536Pugh PJ, Jones RD, Jones TH, Channer KS. Heart failure as an inflammatory condition: potential role for androgens as immune modulators. Eur J Heart Fail. 2002 Dec;4(6):673-80. doi: 10.1016/s1388-9842(02)00162-9.
- Background: PubMed 12634873Anker SD, Al-Nasser FO. Chronic heart failure as a metabolic disorder. Heart Fail Monit. 2000;1(2):42-9.
- Background: PubMed 9244221Anker SD, Chua TP, Ponikowski P, Harrington D, Swan JW, Kox WJ, Poole-Wilson PA, Coats AJ. Hormonal changes and catabolic/anabolic imbalance in chronic heart failure and their importance for cardiac cachexia. Circulation. 1997 Jul 15;96(2):526-34. doi: 10.1161/01.cir.96.2.526.
- Background: PubMed 12559538Kontoleon PE, Anastasiou-Nana MI, Papapetrou PD, Alexopoulos G, Ktenas V, Rapti AC, Tsagalou EP, Nanas JN. Hormonal profile in patients with congestive heart failure. Int J Cardiol. 2003 Feb;87(2-3):179-83. doi: 10.1016/s0167-5273(02)00212-7.
- Background: PubMed 10843161Moriyama Y, Yasue H, Yoshimura M, Mizuno Y, Nishiyama K, Tsunoda R, Kawano H, Kugiyama K, Ogawa H, Saito Y, Nakao K. The plasma levels of dehydroepiandrosterone sulfate are decreased in patients with chronic heart failure in proportion to the severity. J Clin Endocrinol Metab. 2000 May;85(5):1834-40. doi: 10.1210/jcem.85.5.6568.
- Background: PubMed 17030678Jankowska EA, Biel B, Majda J, Szklarska A, Lopuszanska M, Medras M, Anker SD, Banasiak W, Poole-Wilson PA, Ponikowski P. Anabolic deficiency in men with chronic heart failure: prevalence and detrimental impact on survival. Circulation. 2006 Oct 24;114(17):1829-37. doi: 10.1161/CIRCULATIONAHA.106.649426. Epub 2006 Oct 9.
- Background: PubMed 19477405Jankowska EA, Filippatos G, Ponikowska B, Borodulin-Nadzieja L, Anker SD, Banasiak W, Poole-Wilson PA, Ponikowski P. Reduction in circulating testosterone relates to exercise capacity in men with chronic heart failure. J Card Fail. 2009 Jun;15(5):442-50. doi: 10.1016/j.cardfail.2008.12.011. Epub 2009 Feb 10.
- BackgroundP Peñafiel, DA Pascual, B. Redondo, P Nicolas, PL Tornel, J Sanchez-Mas, G de la Morena, M Valdés. Anabolic deficiency as determinant of functional impairment and prognosis in heart failure patients. European journal of Heart Failure 2007;6(supl 1):146.
- MeSH TermsLink provided by the sponsor.
- Spanish Cardiology SocietyLink provided by the sponsor.
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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.
Domingo A Pascual-Figal, MD, PhD principal investigator
Hospital Universitario Virgen Arrixaca
Antoni Bayes-Genis, MD, PhD principal investigator
Germans Trias i Pujol Hospital
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 undecanoate and Saline isotonic solution in people with Heart Failure, run by Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia at 1 site in Spain.
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 7 inclusion and 12 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 13 Dec 2017. 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 Spain. 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. Some participants in this study may receive a placebo. 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?
Death (time frame: 1 year). 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 NCT01813201, which also lists 21 linked publications.
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 Dec 2017.