Androgen DeficiencyHEART-MENDNCT01190904
Hormones and Sexual Function Predict Outcomes in Revascularized Men With Diabetes
An observational study of Androgen Deficiency and AD, run by Icahn School of Medicine at Mount Sinai at 5 sites in United States.
Trial summary
The purpose of this study is to find out if androgen deficiency (low levels of testosterone, a male hormone produced by the sex glands) and erectile dysfunction (sexual dysfunction) will predict over time the development of a heart attack, stroke, or death in men with Diabetes Mellitus who have angiographically proven… Read more about this study
- Who is it for?
- Ages 18 to 75 years, men only
- Conditions the study is for
- Androgen Deficiency, AD, Erectile Dysfunction
- How many people
- 568 participants
- Where
- 5 sitesUnited States
- Study dates
- Jan 2010to Jul 2016
- 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 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Men with diabetes mellitus (DM) and coronary artery disease (CAD) following catheterization.
Who may be able to join
- Male age [18-75 years];
- Type 2 Diabetes, defined according to the American Diabetes Association as history of: a) presence of classic symptoms of DM with unequivocal elevation of plasma glucose (2-hour post-prandial or random of >200 mg/dL (11mmol/L), b) fasting plasma glucose elevation on more than 1 occasion of at least 126 mg/dL (7mmol/L) or c) HA1C > 6.5, currently undergoing pharmacological or non-pharmacological treatment;
- Angiographically confirmed Coronary Artery Disease (≥50%) with or without PCI;
- Indication for revascularization based upon symptoms of angina and/or objective evidence of myocardial ischemia;
- Willingness to comply with all follow-up required study visits; and
- Signed and received copy of informed consent
Who cannot join
- Severe congestive heart failure (class III or IV according to NYHA, or pulmonary edema) at the time of enrollment;
- Previous stroke within 6 months;
- Prior history of significant bleeding (within the previous 6 months) that might be expected to occur during PCI/DES related anticoagulation;
- Acute ST-elevation MI (Q-wave) within 72 hours prior to enrollment requiring revascularization;
- Abnormal creatine kinase (CK > 2x normal); or abnormal CK-MB levels at time of randomization;
- Contraindication to either CABG or PCI/DES because of a coexisting clinical condition];
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- Significant leukopenia, neutropenia, thrombocytopenia, anemia, or known bleeding diathesis;
- Intolerance or contraindication to aspirin or both clopidogrel and ticlopidine;
- Dementia with a Mini Mental Status Examination (MMSE) score of <20;
- Extra-cardiac illness that is expected to limit survival to less than 5 years (e.g. oxygen-dependent chronic obstructive pulmonary disease, active hepatitis or significant hepatic failure, severe renal disease);
- Geographically inaccessible for follow-up visits required by protocol.
- Additional Ancillary Study Exclusions. Exclusion criteria that are unique to the proposed study are prior use of hormonal therapy (HRT) with testosterone in men at baseline and current use of sex-hormone antagonist medications at baseline.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Elmhurst Hospital
Elmhurst, New York, 11373
Hudson Heart Group
Guttenberg, New Jersey, 07093
Winthorp University Hospital
Mineola, New York, 11501
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Stony Brook University Hospital
Stony Brook, New York, 11794
About this study
The purpose of this study is to find out if androgen deficiency (low levels of testosterone, a male hormone produced by the sex glands) and erectile dysfunction (sexual dysfunction) will predict over time the development of a heart attack, stroke, or death in men with Diabetes Mellitus who have angiographically proven coronary artery disease (CAD) (≥50%) with or without percutaneous coronary intervention (PCI). A substudy aims to show the different factors and processes that may show a relationship between sexual function and levels of androgen in the body to heart disease.
Read the detailed description
Diabetes mellitus (DM) and multi-vessel coronary artery disease (CAD) entail significant risk for progression of cardiac morbidity and mortality. Compelling recent research points to biological pathways that link DM and CAD to androgen status and sexual function. We hypothesize that androgen deficiency (AD) and erectile dysfunction (ED) independently serve as sentinel indicators, predicting the future development of adverse cardiovascular and cerebrovascular events in men with diabetes following coronary revascularization.
ED is emerging as a barometer of overall endothelial function. We hypothesize that as a consequence of this relationship, erectile dysfunction is predictive of cardiovascular outcomes in men with diabetes and CAD. We also propose that AD affects morbidity and mortality in men with DM and CAD by influencing presentation and progression of endothelial dysfunction as well as inflammation and hemostasis.
We propose to investigate four specific aims using 1,143 diabetic men who have angiographically proven coronary artery disease (CAD) (≥50%) in at least one major epicardial vessel with or without percutaneous coronary intervention (PCI). Specific aims of this study are: 1) To determine whether androgen status at baseline independently predicts primary and secondary endpoints in men (n=1,143) with DM and CAD. 2) To determine whether erectile dysfunction at baseline independently predicts cardiovascular outcomes in men with DM and CAD. 3) To determine whether change of androgen status and sexual function over time independently predict cardiovascular outcomes in men with DM and CAD. 4) To demonstrate specific mediators and pathways that link sexual function and androgen status to cardiovascular disease.
The primary endpoint is defined as the combined all-cause mortality, non-fatal myocardial infarction (MI), and stroke. Secondary endpoints include major adverse cardiovascular and cerebrovascular events (MACCE), defined as death, nonfatal MI, stroke or revascularization at one year and angina status as evaluated with the Seattle Angina Questionnaire (SAQ) at 6 months, 12 months, 18 months, 24 months, 30 months and 36 months following catheterization.
- Conditions
- Androgen Deficiency, AD, Erectile Dysfunction, ED, Diabetes Mellitus, Coronary Artery Disease
- Keywords
- Androgen deficiency, Erectile dysfunction, Coronary Artery Disease, Coronary Revascularization, Diabetes mellitus, MI, Stroke, MACCE, DM, ED, CAD, Development of predictive cardiovascular/cerebrovascular AE
- Medical subject headings
- Erectile Dysfunction, Diabetes Mellitus, Coronary Artery Disease, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Coronary Artery Disease (≥50%) with or without PCI | We propose to investigate four specific aims using 1,143 diabetic men who have CAD (≥50%) lesion in at least one major epicardial vessel with or without PCI. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite outcome of all-cause mortality
The primary outcome is time to composite outcome of all-cause mortality, MI or stroke.
Measured: up to 3 Years
Secondary outcomes (8)
To determine whether androgen status at baseline independently predicts primary and secondary endpoints in men (n=1,143) with DM and CAD.
Androgen profile consists of total, free, and bio-available testosterone (T) and testosterone:estradiol ratio. Hypothesis: AD at baseline (defined by total T < 300 ng/dl) will be an independent predictor of primary and secondary outcomes.
Measured: Baseline
To determine whether erectile dysfunction at baseline independently predicts cardiovascular outcomes in men with DM and CAD.
ED severity will be determined using the International Index of Erectile Function (IIEF), a standard instrument that is available in multiple translations and has excellent cross-cultural validity.
Hypothesis: Severe ED at baseline (IIEF < 11), while controlling for demographic and clinical covariates, will be an independent predictor of primary and secondary cardiac outcomes.
Measured: Baseline
MACCE
Secondary endpoints include major adverse cardiovascular and cerebrovascular events (MACCE), defined as death, nonfatal MI, stroke or revascularization at one year and angina status as evaluated with the Seattle Angina Questionnaire (SAQ) at 6, 12, 18, 24, 30 and 36 months following catheterization.
Measured: at 6 months following catheterization
MACCE
Secondary endpoints include major adverse cardiovascular and cerebrovascular events (MACCE), defined as death, nonfatal MI, stroke or revascularization at one year and angina status as evaluated with the Seattle Angina Questionnaire (SAQ) at 6, 12, 18, 24, 30 and 36 months following catheterization.
Measured: at 12 months following catheterization
MACCE
Secondary endpoints include major adverse cardiovascular and cerebrovascular events (MACCE), defined as death, nonfatal MI, stroke or revascularization at one year and angina status as evaluated with the Seattle Angina Questionnaire (SAQ) at 6, 12, 18, 24, 30 and 36 months following catheterization.
Measured: at 18 months following catheterization
MACCE
Secondary endpoints include major adverse cardiovascular and cerebrovascular events (MACCE), defined as death, nonfatal MI, stroke or revascularization at one year and angina status as evaluated with the Seattle Angina Questionnaire (SAQ) at 6, 12, 18, 24, 30 and 36 months following catheterization.
Measured: at 24 months following catheterization
MACCE
Secondary endpoints include major adverse cardiovascular and cerebrovascular events (MACCE), defined as death, nonfatal MI, stroke or revascularization at one year and angina status as evaluated with the Seattle Angina Questionnaire (SAQ) at 6, 12, 18, 24, 30 and 36 months following catheterization.
Measured: at 30 months following catheterization
MACCE
Secondary endpoints include major adverse cardiovascular and cerebrovascular events (MACCE), defined as death, nonfatal MI, stroke or revascularization at one year and angina status as evaluated with the Seattle Angina Questionnaire (SAQ) at 6, 12, 18, 24, 30 and 36 months following catheterization.
Measured: at 36 months following catheterization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2010 (estimated)
- Study startJan 2010
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Androgen DeficiencyStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe 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
- 568 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mary Ann McLaughlin, MD, MPH, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01190904
- Sponsor's protocol ID
- GCO 06-0648
- Other IDs
- R01DK077954
- Acronym
- HEART-MEND
- Status last verified
- Aug 2016
- First submitted
- 24 Aug 2010
- Last updated
- 11 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hormones and Sexual Function Predict Outcomes in Revascularized Men With Diabetes
- ClinicalTrials.gov ID
- NCT01190904
- Acronym / sponsor ID
- HEART-MEND / GCO 06-0648
- Conditions
- Androgen Deficiency, AD, Erectile Dysfunction, ED, Diabetes Mellitus, Coronary Artery Disease
- Keywords
- Androgen deficiency, Erectile dysfunction, Coronary Artery Disease, Coronary Revascularization, Diabetes mellitus, MI, Stroke, MACCE
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 568 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Jan 2010
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 30 Aug 2010 (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 find out if androgen deficiency (low levels of testosterone, a male hormone produced by the sex glands) and erectile dysfunction (sexual dysfunction) will predict over time the development of a heart attack, stroke, or death in men with Diabetes Mellitus who have angiographically proven coronary artery disease (CAD) (≥50%) with or without percutaneous coronary intervention (PCI). A substudy aims to show the different factors and processes that may show a relationship between sexual function and levels of androgen in the body to heart disease.
Detailed description
Diabetes mellitus (DM) and multi-vessel coronary artery disease (CAD) entail significant risk for progression of cardiac morbidity and mortality. Compelling recent research points to biological pathways that link DM and CAD to androgen status and sexual function. We hypothesize that androgen deficiency (AD) and erectile dysfunction (ED) independently serve as sentinel indicators, predicting the future development of adverse cardiovascular and cerebrovascular events in men with diabetes following coronary revascularization.
ED is emerging as a barometer of overall endothelial function. We hypothesize that as a consequence of this relationship, erectile dysfunction is predictive of cardiovascular outcomes in men with diabetes and CAD. We also propose that AD affects morbidity and mortality in men with DM and CAD by influencing presentation and progression of endothelial dysfunction as well as inflammation and hemostasis.
We propose to investigate four specific aims using 1,143 diabetic men who have angiographically proven coronary artery disease (CAD) (≥50%) in at least one major epicardial vessel with or without percutaneous coronary intervention (PCI). Specific aims of this study are: 1) To determine whether androgen status at baseline independently predicts primary and secondary endpoints in men (n=1,143) with DM and CAD. 2) To determine whether erectile dysfunction at baseline independently predicts cardiovascular outcomes in men with DM and CAD. 3) To determine whether change of androgen status and sexual function over time independently predict cardiovascular outcomes in men with DM and CAD. 4) To demonstrate specific mediators and pathways that link sexual function and androgen status to cardiovascular disease.
The primary endpoint is defined as the combined all-cause mortality, non-fatal myocardial infarction (MI), and stroke. Secondary endpoints include major adverse cardiovascular and cerebrovascular events (MACCE), defined as death, nonfatal MI, stroke or revascularization at one year and angina status as evaluated with the Seattle Angina Questionnaire (SAQ) at 6 months, 12 months, 18 months, 24 months, 30 months and 36 months following catheterization.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Coronary Artery Disease (≥50%) with or without PCI | – | –We propose to investigate four specific aims using 1,143 diabetic men who have CAD (≥50%) lesion in at least one major epicardial vessel with or without PCI. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Men with diabetes mellitus (DM) and coronary artery disease (CAD) following catheterization.
Key inclusion criteria (6 listed)
- Male age [18-75 years];
- Type 2 Diabetes, defined according to the American Diabetes Association as history of: a) presence of classic symptoms of DM with unequivocal elevation of plasma glucose (2-hour post-prandial or random of >200 mg/dL (11mmol/L), b) fasting plasma glucose elevation on more than 1 occasion of at least 126 mg/dL (7mmol/L) or c) HA1C > 6.5, currently undergoing pharmacological or non-pharmacological treatment;
- Angiographically confirmed Coronary Artery Disease (≥50%) with or without PCI;
- Indication for revascularization based upon symptoms of angina and/or objective evidence of myocardial ischemia;
- Willingness to comply with all follow-up required study visits; and
Key exclusion criteria (12 listed)
- Severe congestive heart failure (class III or IV according to NYHA, or pulmonary edema) at the time of enrollment;
- Previous stroke within 6 months;
- Prior history of significant bleeding (within the previous 6 months) that might be expected to occur during PCI/DES related anticoagulation;
- Acute ST-elevation MI (Q-wave) within 72 hours prior to enrollment requiring revascularization;
- Abnormal creatine kinase (CK > 2x normal); or abnormal CK-MB levels at time of randomization;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Composite outcome of all-cause mortality
Time frame: up to 3 Years
The primary outcome is time to composite outcome of all-cause mortality, MI or stroke.
8 secondary outcomes
To determine whether androgen status at baseline independently predicts primary and secondary endpoints in men (n=1,143) with DM and CAD.
Time frame: Baseline
To determine whether erectile dysfunction at baseline independently predicts cardiovascular outcomes in men with DM and CAD.
Time frame: Baseline
MACCE
Time frame: at 6 months following catheterization
MACCE
Time frame: at 12 months following catheterization
MACCE
Time frame: at 18 months following catheterization
MACCE
Time frame: at 24 months following catheterization
MACCE
Time frame: at 30 months following catheterization
MACCE
Time frame: at 36 months following catheterization
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 11 Aug 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.
Mary Ann McLaughlin, MD, MPH principal investigator
Icahn School of Medicine at Mount Sinai
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Androgen Deficiency and AD, run by Icahn School of Medicine at Mount Sinai at 5 sites in United States.
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 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 11 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. 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?
Composite outcome of all-cause mortality (time frame: up to 3 Years). 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 11 Aug 2016; AzTrials last refreshed its copy on 31 Oct 2026.