Hormones and Sexual Function Predict Outcomes in Revascularized Men With Diabetes "HEART-MEND"

Completed

Phase N/A Results N/A

Update History

28 Nov '15
A location was updated in Guttenberg.
New
The overall status was removed for Hudson Heart Group.
A location was updated in Elmhurst.
New
The overall status was removed for Elmhurst Hospital.
A location was updated in Mineola.
New
The overall status was removed for Winthorp University Hospital.
A location was updated in New York.
New
The overall status was removed for Icahn School of Medicine at Mount Sinai.
A location was updated in Stony Brook.
New
The overall status was removed for Stony Brook University Hospital.
15 Jan '14
A location was updated in Bronx.
New
The overall status was updated to "Withdrawn" at Montefiore Medical Center.
24 May '12
The Summary of Purpose was updated.
New
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.
Old
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 are undergoing coronary revascularization. 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.
The description was updated.
New
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.
Old
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 following percutaneous coronary revascularization for either single or multiple vessel disease. 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 coronary revascularization.
The eligibility criteria were updated.
New
Inclusion Criteria: - 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 Exclusion Criteria: - 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]; - 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.
Old
Inclusion Criteria: 1. Male or Female age [18-75 years]; 2. 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; 3. Angiographically confirmed CAD critical (³ 70%) lesion in at least one major epicardial vessel and amenable to PCI; 4. Indication for revascularization based upon symptoms of angina and/or objective evidence of myocardial ischemia; 5. Willingness to comply with all follow-up required study visits; and 6. Signed and received copy of informed consent Exclusion Criteria: 1. Severe congestive heart failure (class III or IV according to NYHA, or pulmonary edema) at the time of enrollment; 2. Previous stroke within 6 months; 3. Prior history of significant bleeding (within the previous 6 months) that might be expected to occur during PCI/DES related anticoagulation; 4. Acute ST-elevation MI (Q-wave) within 72 hours prior to enrollment requiring revascularization; 5. Abnormal creatine kinase (CK > 2x normal); or abnormal CK-MB levels at time of randomization; 6. Contraindication to either CABG or PCI/DES because of a coexisting clinical condition]; 7. Significant leukopenia, neutropenia, thrombocytopenia, anemia, or known bleeding diathesis; 8. Intolerance or contraindication to aspirin or both clopidogrel and ticlopidine; 9. Dementia with a Mini Mental Status Examination (MMSE) score of <20; 10. 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); 11. Geographically inaccessible for follow-up visits required by protocol. 12. 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.
1 Dec '11
Trial acronym was updated.
New
HEART-MEND
The Summary of Purpose was updated.
New
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 are undergoing coronary revascularization. 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.
Old
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 attach, stroke, or death in men with Diabetes Mellitus who are undergoing coronary revascularization. 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.
The description was updated.
New
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 following percutaneous coronary revascularization for either single or multiple vessel disease. 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 coronary revascularization.
Old
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 five specific aims using 1,143 diabetic men following percutaneous coronary revascularization for either single or multiple vessel disease. 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, 24 months, and 36 months following coronary revascularization.