Heart FailureNCT01377103
Testosterone Therapy in Heart Failure
A study testing testerone gel in people with Heart Failure and Hypogonadism, run by Cedars-Sinai Medical Center.
Trial summary
The purpose of this study is to evaluate whether benefits of topical testosterone on symptoms and function of male HF patients, and its effects on rehospitalization rates and quality of life. Read more about this study
- Who is it for?
- Ages 36 to 79 years, men only
- Conditions the study is for
- Heart Failure, Hypogonadism
- What is being tested?
- testerone gel
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jul 2011to Dec 2012
- Phase
- Interventional
- 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 36 to 79 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- male
- NYHA class II-IV Heart Failure
- age > 35 < 80
- total testosterone level of <5 ng/ml
Who cannot join
- elevated prostate specific antigen
- elevated total or free testosterone level
- prostate cancer or evidence of symptomatic prostatism
- untreated prolactinemia or history of breast cancer
About this study
Official title: Cardiovascular and Functional Effects of Testosterone Therapy for Hypogonadal Patients With Heart Failure
The purpose of this study is to evaluate whether benefits of topical testosterone on symptoms and function of male HF patients, and its effects on rehospitalization rates and quality of life.
Read the detailed description
Recent evidence has started to emerge regarding the benefits of testosterone in the heart failure (HF) population. Firstly, testosterone directly augments vascular resistance by causing vasodilation of peripheral vessels which can decrease afterload and improve cardiac output. In addition, testosterone causes coronary artery vasodilation and improves cardiac ischemic threshold based on subjective and objective measures. Clinically, several studies have pointed out the potential benefits patients with HF can derive from testosterone therapy. Measures of cardiopulmonary function tests, six minute walk test, incremental shuttle walk test and baroreflex sensitivity, all of which have prognostic implications for patients with HF, show improvement with the addition of testosterone therapy to traditional-medical management. In addition to these objective measurements, mood, NYHA functional class and muscle strength are all improved by treatment with testosterone supplementation. While past studies have used functional and prognostic measures as outcomes, other issues common in patients with HF, such as sexual dysfunction and repeat hospitalizations, have the potential for improvement with testosterone therapy
The majority of studies performed in the past have utilized intramuscular or transdermal patch delivery systems of testosterone as a means for supplementation. These methods have inherent issues as a means of treatment as patients often times do not have the means to receive intramuscular injections and patches have a high level of skin reactions making compliance difficult. Topical administration of testosterone gel may prove to be a more efficacious method for testosterone supplementation with a lower side effect profile and adequate absorption. It has been used with success by the general public for treatment of hypogonadal symptoms, but has not been studied in the HF population. With the emergence of studies showing promising benefits of testosterone supplementation in the HF population, the ease of topical administration for this population would provide benefits to millions suffering from HF.
The investigators study aims to find the benefits of topical testosterone on symptoms and function of HF patients, and its effects on rehospitalization rates and quality of life.
- Conditions
- Heart Failure, Hypogonadism
- Being tested
- testerone gel, Placebo
- Keywords
- heart failure, hypogonadism, testosterone
- Medical subject headings
- Heart Failure, Hypogonadism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
testerone gelDrug
Also called AndroGel(R)
5g daily for 4 weeks then 7.5 or 10g daily for 8 weeks; transdermal testosterone gel
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo Gel Receives: Drug: Placebo |
| Testosterone Supplementation | Active comparator | Testosterone Gel Receives: Drug: testerone gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
heart failure outcomes
rehospitalization rates, mortality, New York Heart Association class and symptomatolgy
Measured: 16 months
depression and mood
Beck Depression Inventory: a 21-question multiple-choice self-report inventory for measuring the severity of depression
Measured: 16 months
quality of life
Minnesota Living with Heart Failure Questionnaire
Measured: 16 months
Secondary outcomes (3)
overall satisfaction
Minnesota Living with Heart Failure Questionnaire
Measured: 16 months
compliance
documentation of study medication usage
Measured: 16 months
markers for heart failure
natriuretic peptide, creatinine, and left ventricular ejection fraction.
Measured: 16 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2011 (estimated)
- Study startJul 2011
- Primary completionOct 2012 (estimated)
- Study completionDec 2012 (estimated)
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 Cedars-Sinai Medical CenterThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cedars-Sinai Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott
- Responsible party
- Principal investigator, Ernst Schwarz, MD, PhD, Cedars-Sinai Medical Center
- Investigators
- Ernst Schwarz, MD, PhD, Principal investigator, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01377103
- Sponsor's protocol ID
- TT-1
- Status last verified
- Apr 2011
- First submitted
- 18 May 2011
- Last updated
- 19 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiovascular and Functional Effects of Testosterone Therapy for Hypogonadal Patients With Heart Failure
- ClinicalTrials.gov ID
- NCT01377103
- Acronym / sponsor ID
- TT-1
- Conditions
- Heart Failure, Hypogonadism
- Keywords
- heart failure, hypogonadism, testosterone
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Cedars-Sinai Medical CenterUniversity, hospital or other
- Collaborators
- Abbott
- Study start
- Jul 2011
- Primary completion
- Oct 2012 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 21 Jun 2011 (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 evaluate whether benefits of topical testosterone on symptoms and function of male HF patients, and its effects on rehospitalization rates and quality of life.
Detailed description
Recent evidence has started to emerge regarding the benefits of testosterone in the heart failure (HF) population. Firstly, testosterone directly augments vascular resistance by causing vasodilation of peripheral vessels which can decrease afterload and improve cardiac output. In addition, testosterone causes coronary artery vasodilation and improves cardiac ischemic threshold based on subjective and objective measures. Clinically, several studies have pointed out the potential benefits patients with HF can derive from testosterone therapy. Measures of cardiopulmonary function tests, six minute walk test, incremental shuttle walk test and baroreflex sensitivity, all of which have prognostic implications for patients with HF, show improvement with the addition of testosterone therapy to traditional-medical management. In addition to these objective measurements, mood, NYHA functional class and muscle strength are all improved by treatment with testosterone supplementation. While past studies have used functional and prognostic measures as outcomes, other issues common in patients with HF, such as sexual dysfunction and repeat hospitalizations, have the potential for improvement with testosterone therapy
The majority of studies performed in the past have utilized intramuscular or transdermal patch delivery systems of testosterone as a means for supplementation. These methods have inherent issues as a means of treatment as patients often times do not have the means to receive intramuscular injections and patches have a high level of skin reactions making compliance difficult. Topical administration of testosterone gel may prove to be a more efficacious method for testosterone supplementation with a lower side effect profile and adequate absorption. It has been used with success by the general public for treatment of hypogonadal symptoms, but has not been studied in the HF population. With the emergence of studies showing promising benefits of testosterone supplementation in the HF population, the ease of topical administration for this population would provide benefits to millions suffering from HF.
The investigators study aims to find the benefits of topical testosterone on symptoms and function of HF patients, and its effects on rehospitalization rates and quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboPlacebo Gel |
| Testosterone Supplementation | Active comparator | Drug: testerone gelTestosterone Gel |
Who may qualify
- Ages
- 36 to 79 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- male
- NYHA class II-IV Heart Failure
- age > 35 < 80
- total testosterone level of <5 ng/ml
Key exclusion criteria (4 listed)
- elevated prostate specific antigen
- elevated total or free testosterone level
- prostate cancer or evidence of symptomatic prostatism
- untreated prolactinemia or history of breast cancer
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 |
|---|---|---|
| testerone gelAlso: AndroGel(R)5g daily for 4 weeks then 7.5 or 10g daily for 8 weeks; transdermal testosterone gel | Drug | Testosterone Supplementation |
| Placebo | Drug | Placebo |
Primary outcome
heart failure outcomes
Time frame: 16 months
rehospitalization rates, mortality, New York Heart Association class and symptomatolgy
depression and mood
Time frame: 16 months
Beck Depression Inventory: a 21-question multiple-choice self-report inventory for measuring the severity of depression
quality of life
Time frame: 16 months
Minnesota Living with Heart Failure Questionnaire
3 secondary outcomes
overall satisfaction
Time frame: 16 months
compliance
Time frame: 16 months
markers for heart failure
Time frame: 16 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2017.
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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.
Ernst Schwarz, MD, PhD principal investigator
Cedars-Sinai Medical Center
Questions about this trial
What is this clinical trial studying?
A study testing testerone gel in people with Heart Failure and Hypogonadism, run by Cedars-Sinai Medical Center.
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 4 inclusion and 4 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: withdrawn, as of the sponsor's last update on 19 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
heart failure outcomes (time frame: 16 months). 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 19 Jul 2017.