HypogonadismPhase 4NCT03126656
Effects of Testosterone on Myocardial Repolarization
A Phase 4 study testing Testosterone Undecanoate in people with Hypogonadism and Chronic Heart Failure, run by University of Roma La Sapienza.
Trial summary
The main of the study is to evaluate the effect of testosterone on ventricular repolarization in patients with mild heart failure, at risk for sudden cardiac death. The electrocardiographic markers studied are QT variability index, the short term variability index. Read more about this study
- Who is it for?
- Ages 40 to 70 years, men only
- Conditions the study is for
- Hypogonadism, Chronic Heart Failure
- What is being tested?
- Testosterone Undecanoate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 123 participants
- Where
- No sites listed yet
- Study dates
- Sep 2016to Apr 2017
- 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 40 to 70 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 40 and 70 aa with blood testosterone values <11.4 nmol / L;
- Sinus rhythm at 12-lead ECG;
- Hypogonadism: Total Testosterone <3.5 ng / ml or Free testosterone <250 pmol / L (10 pg / mL) detected (8: 00-11: 00 am) in two successive measurements taken baseline and confirmed at 7 days apart, reduced libido and / or at least two symptoms of hypogonadism evaluated AMS questionnaire
- previous myocardial infarction and relief echocardiographic fraction of left ventricular ejection greater than or equal to 40% (in chronic heart failure patients);
- stable clinical and hemodynamic conditions for more than three months;
- No therapeutic changes in the last 3 months;
- signing the informed consent.
Who cannot join
- therapy with testosterone undertaken within 6 months of enrollment or other therapy with steroids undertaken within 3 months thereafter
- Clinical history of prostate cancer
- elevated PSA values (adjusted for age)
- digital rectal exploration (DRE) suggestive of prostate cancer
- Symptoms of benign prostatic hypertrophy (BPH) with severe obstructive symptoms
- Hematocrit> 52% at baseline
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- History of clinically significant hepatic, hematological, renal pathology
- Clinical history of breast cancer
- Hyperprolactinemia or other endocrine diseases (empty sella syndrome and pituitary expansive diseases measured by MRI)
- Age less than 40 or older than 70 years;
- Severe left ventricular systolic dysfunction (left ventricular ejection fraction <40%) and / or echocardiographic evidence of severe valvular disease;
- chronic atrial fibrillation or frequent extrasystoles (> 1 extrasystole / min);
- Presence of complete branch block;
- Unstable clinical and hemodynamic conditions and / or changes in therapy over the last three months;
- Presence of prostatic hyperplasia decisive severe obstruction to uroflow study;
- neoplasms diagnosed and treated less than five years later;
- Any other condition that medical judgment precludes patient safety
About this study
Official title: Effects of Testosterone on Myocardial Repolarization in Patients With Hypogonadism With/Without Chronic Heat Failure (NYHA Class I-II)
The main of the study is to evaluate the effect of testosterone on ventricular repolarization in patients with mild heart failure, at risk for sudden cardiac death. The electrocardiographic markers studied are QT variability index, the short term variability index.
Read the detailed description
Background:
It has been widely demonstrated in experimental cardiology that estrogen may play a protective role on cardiovascular system, reducing myocardial damage in ischemia-reperfusion injury. Poor are the contributions of the effects of estrogen in the presence of testosterone which also showed potentially cardioprotective effects. Recently it has emerged strong evidence showing that the increase in the repolarization phase of myocardial duration and its temporal dispersion are predictive markers of cardiac death in post-ischemic dilated cardiomyopathy. In addition, the temporal dispersion of the final part of the repolarization phase (Tpeak-Tend) is specifically predictive for sudden cardiac death. In fact, the investigators propose the following plan of experimental study. It will be measured by the duration of the repolarization phase and its basal temporal dispersion and the peak of the heart rate obtained during stress test, in male subjects before and during testosterone replacement therapy.
Patients evaluation baseline, after 1 month and after 6 months of follow up:
Endocrinological evaluation with measurement of body weight, height, BMI calculation and (digital rectal examination) DRE, blood sample.
Laboratory:
Dosage of serum total testosterone, total and free PSA, blood count.
Cardiological evaluation:
- Patient's clinical objective examination: measurement of blood pressure and basal heart rate.
- Traditional resting electrocardiogram 12-lead ECG in the supine position and 50 to 25 mm / sec, 10 millivolts.
- Electrocardiographic single lead computerised registration (DI, D II and D III) of 5 minutes baseline and 5 minutes with controlled breathing (15 breaths / min), using the Spectralink 2011 program, which allows us to identify and calculate the variables object of this study;
- Stress cycle electrocardiogram by modified Bruce protocol (25 watts every 2 minutes). The test is interrupted reaching 90% of the maximum heart rate, calculated based on the age of the patient, or to muscular exhaustion. A single lead electrocardiographic recording is started in the 10 minutes period after stress test, using Spectralink 2011 which allows investigators to calculate the variables studied.
- trans thoracic echocardiogram with assessment of ejection fraction and any kinetic alterations in contractility and / or valvular heart disease, degree of possible diastolic dysfunction (E / A), size (interventricular septum, posterior wall, end-systolic and end-diastolic diameter in mm) and volumes (end-diastolic and end-systolic volume) of the left and right ventricle sections.
- Conditions
- Hypogonadism, Chronic Heart Failure
- Being tested
- Testosterone Undecanoate
- Keywords
- testosterone, chronic heart failure
- Medical subject headings
- Hypogonadism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Testosterone UndecanoateDrug
just hypogonadic patients enrolled received hormone replacement therapy with testosterone undecanoate 1000 mg/4ml intramuscular (IM) at baseline, after 6 weeks and 12 weeks after the first evaluation
| Study group | Role | What they receive |
|---|---|---|
| Hypogonadic with chronic heart failure | Experimental | patients suffering from mild to moderate heart failure (LVEF ≥ 40%, NYHA I-II), and hypogonadism (plasma testosterone levels <11.4 nmol / L); Receives: Drug: Testosterone Undecanoate |
| Hypogonadic | Experimental | patients just with hypogonadism (testosterone <11.4 nmol / L) in the absence of documented cardiovascular disease Receives: Drug: Testosterone Undecanoate |
| chronic heart failure | No intervention | patients suffering from mild to moderate heart failure (LVEF ≥ 40%, NYHA I-II) with normal testosterone levels(plasma testosterone levels > 11.4 nmol / L), in optimized standard therapy for heart failure |
What is being measured
The primary outcome is the main question the study is designed to answer.
QT duration reduction
Reduction of the absolute QT interval value and its space and time dispersion
Measured: baseline (before testosterone administration), after 1 month and after 6 months of follow up
Secondary outcomes (1)
hypogonadism treatment
restoration of normal testosterone blood levels
Measured: baseline (before testosterone administration), after 1 month and after 6 months of follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2017
- Study startSep 2016
- Primary completionApr 2017
- Study completionApr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypogonadismStudies 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Roma La Sapienza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gianfranco Piccirillo, University of Roma La Sapienza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03126656
- Sponsor's protocol ID
- TECHF001
- Status last verified
- May 2017
- First submitted
- 19 Apr 2017
- Last updated
- 8 May 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Testosterone on Myocardial Repolarization in Patients With Hypogonadism With/Without Chronic Heat Failure (NYHA Class I-II)
- ClinicalTrials.gov ID
- NCT03126656
- Acronym / sponsor ID
- TECHF001
- Conditions
- Hypogonadism, Chronic Heart Failure
- Keywords
- testosterone, chronic heart failure
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- University of Roma La SapienzaUniversity, hospital or other
- Study start
- Sep 2016 (actual)
- Primary completion
- Apr 2017 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 24 Apr 2017 (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.
The main of the study is to evaluate the effect of testosterone on ventricular repolarization in patients with mild heart failure, at risk for sudden cardiac death. The electrocardiographic markers studied are QT variability index, the short term variability index.
Detailed description
Background:
It has been widely demonstrated in experimental cardiology that estrogen may play a protective role on cardiovascular system, reducing myocardial damage in ischemia-reperfusion injury. Poor are the contributions of the effects of estrogen in the presence of testosterone which also showed potentially cardioprotective effects. Recently it has emerged strong evidence showing that the increase in the repolarization phase of myocardial duration and its temporal dispersion are predictive markers of cardiac death in post-ischemic dilated cardiomyopathy. In addition, the temporal dispersion of the final part of the repolarization phase (Tpeak-Tend) is specifically predictive for sudden cardiac death. In fact, the investigators propose the following plan of experimental study. It will be measured by the duration of the repolarization phase and its basal temporal dispersion and the peak of the heart rate obtained during stress test, in male subjects before and during testosterone replacement therapy.
Patients evaluation baseline, after 1 month and after 6 months of follow up:
Endocrinological evaluation with measurement of body weight, height, BMI calculation and (digital rectal examination) DRE, blood sample.
Laboratory:
Dosage of serum total testosterone, total and free PSA, blood count.
Cardiological evaluation:
- Patient's clinical objective examination: measurement of blood pressure and basal heart rate.
- Traditional resting electrocardiogram 12-lead ECG in the supine position and 50 to 25 mm / sec, 10 millivolts.
- Electrocardiographic single lead computerised registration (DI, D II and D III) of 5 minutes baseline and 5 minutes with controlled breathing (15 breaths / min), using the Spectralink 2011 program, which allows us to identify and calculate the variables object of this study;
- Stress cycle electrocardiogram by modified Bruce protocol (25 watts every 2 minutes). The test is interrupted reaching 90% of the maximum heart rate, calculated based on the age of the patient, or to muscular exhaustion. A single lead electrocardiographic recording is started in the 10 minutes period after stress test, using Spectralink 2011 which allows investigators to calculate the variables studied.
- trans thoracic echocardiogram with assessment of ejection fraction and any kinetic alterations in contractility and / or valvular heart disease, degree of possible diastolic dysfunction (E / A), size (interventricular septum, posterior wall, end-systolic and end-diastolic diameter in mm) and volumes (end-diastolic and end-systolic volume) of the left and right ventricle sections.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Hypogonadic with chronic heart failure | Experimental | Drug: Testosterone Undecanoatepatients suffering from mild to moderate heart failure (LVEF ≥ 40%, NYHA I-II), and hypogonadism (plasma testosterone levels <11.4 nmol / L); |
| Hypogonadic | Experimental | Drug: Testosterone Undecanoatepatients just with hypogonadism (testosterone <11.4 nmol / L) in the absence of documented cardiovascular disease |
| chronic heart failure | No intervention | –patients suffering from mild to moderate heart failure (LVEF ≥ 40%, NYHA I-II) with normal testosterone levels(plasma testosterone levels > 11.4 nmol / L), in optimized standard therapy for heart failure |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age between 40 and 70 aa with blood testosterone values <11.4 nmol / L;
- Sinus rhythm at 12-lead ECG;
- Hypogonadism: Total Testosterone <3.5 ng / ml or Free testosterone <250 pmol / L (10 pg / mL) detected (8: 00-11: 00 am) in two successive measurements taken baseline and confirmed at 7 days apart, reduced libido and / or at least two symptoms of hypogonadism evaluated AMS questionnaire
- previous myocardial infarction and relief echocardiographic fraction of left ventricular ejection greater than or equal to 40% (in chronic heart failure patients);
- stable clinical and hemodynamic conditions for more than three months;
Key exclusion criteria (17 listed)
- therapy with testosterone undertaken within 6 months of enrollment or other therapy with steroids undertaken within 3 months thereafter
- Clinical history of prostate cancer
- elevated PSA values (adjusted for age)
- digital rectal exploration (DRE) suggestive of prostate cancer
- Symptoms of benign prostatic hypertrophy (BPH) with severe obstructive symptoms
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 Undecanoatejust hypogonadic patients enrolled received hormone replacement therapy with testosterone undecanoate 1000 mg/4ml intramuscular (IM) at baseline, after 6 weeks and 12 weeks after the first evaluation | Drug | Hypogonadic, Hypogonadic with chronic heart failure |
Primary outcome
QT duration reduction
Time frame: baseline (before testosterone administration), after 1 month and after 6 months of follow up
Reduction of the absolute QT interval value and its space and time dispersion
1 secondary outcome
hypogonadism treatment
Time frame: baseline (before testosterone administration), after 1 month and after 6 months of follow up
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 8 May 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Testosterone Undecanoate in people with Hypogonadism and Chronic Heart Failure, run by University of Roma La Sapienza.
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 17 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 8 May 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. 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?
QT duration reduction (time frame: baseline (before testosterone administration), after 1 month and after 6 months of follow up). 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 8 May 2017.