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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Mount Sinai School of Medicine
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Mount Sinai School of Medicine
ClinicalTrials.gov Identifier:
NCT01190904
First received: August 24, 2010
Last updated: January 13, 2014
Last verified: January 2014
  Purpose

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.


Condition
Androgen Deficiency
AD
Erectile Dysfunction
ED
Diabetes Mellitus
Coronary Artery Disease
Coronary Revascularization

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Hormones and Sexual Function Predict Outcomes in Revascularized Men With Diabetes

Resource links provided by NLM:


Further study details as provided by Mount Sinai School of Medicine:

Primary Outcome Measures:
  • Composite outcome of all-cause mortality [ Time Frame: up to 3 Years ] [ Designated as safety issue: No ]
    The primary outcome is time to composite outcome of all-cause mortality, MI or stroke.


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.

  • To determine whether erectile dysfunction at baseline independently predicts cardiovascular outcomes in men with DM and CAD. [ Time Frame: Baseline ] [ Designated as safety issue: No ]

    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.


  • MACCE [ Time Frame: at 6 months following catheterization ] [ Designated as safety issue: No ]
    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.

  • MACCE [ Time Frame: at 12 months following catheterization ] [ Designated as safety issue: No ]
    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.

  • MACCE [ Time Frame: at 18 months following catheterization ] [ Designated as safety issue: No ]
    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.

  • MACCE [ Time Frame: at 24 months following catheterization ] [ Designated as safety issue: No ]
    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.

  • MACCE [ Time Frame: at 30 months following catheterization ] [ Designated as safety issue: No ]
    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.

  • MACCE [ Time Frame: at 36 months following catheterization ] [ Designated as safety issue: No ]
    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.


Biospecimen Retention:   Samples Without DNA

Inflammatory markers; Hormones: testosterone, estradiol, SHBG


Estimated Enrollment: 1143
Study Start Date: January 2010
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Men with diabetes mellitus (DM) and coronary artery disease (CAD) following catheterization.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01190904

Locations
United States, New Jersey
Hudson Heart Group Recruiting
Guttenberg, New Jersey, United States, 07093
Contact: Felix-Dailey Sterling, MD    201-854-0055      
Principal Investigator: Felix-Dailey Sterling, MD         
United States, New York
Montefiore Medical Center Withdrawn
Bronx, New York, United States, 10461
Elmhurst Hospital Recruiting
Elmhurst, New York, United States, 11373
Contact: Mazullah Kamran, MD    718-334-5015      
Principal Investigator: Mazullah Kamran, MD         
Winthorp University Hospital Recruiting
Mineola, New York, United States, 11501
Contact: Juan Gaztanaga, MD    516-663-4481      
Icahn School of Medicine at Mount Sinai Recruiting
New York, New York, United States, 10029
Contact: Annapoorna Kini, MD    212-241-9984      
Stony Brook University Hospital Recruiting
Stony Brook, New York, United States, 11794
Contact: Luis Gruberg, MD    631-444-1066      
Sponsors and Collaborators
Mount Sinai School of Medicine
Investigators
Principal Investigator: Mary Ann McLaughlin, MD, MPH Mount Sinai School of Medicine
  More Information

No publications provided

Responsible Party: Mount Sinai School of Medicine
ClinicalTrials.gov Identifier: NCT01190904     History of Changes
Other Study ID Numbers: GCO 06-0648, R01DK077954
Study First Received: August 24, 2010
Last Updated: January 13, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Mount Sinai School of Medicine:
Androgen deficiency
Erectile dysfunction
Coronary Artery Disease
Coronary Revascularization
Diabetes mellitus
MI
Stroke
MACCE
DM
ED
CAD
Development of predictive cardiovascular/cerebrovascular AE

Additional relevant MeSH terms:
Sexual Dysfunction, Physiological
Coronary Artery Disease
Coronary Disease
Diabetes Mellitus
Erectile Dysfunction
Myocardial Ischemia
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Endocrine System Diseases
Genital Diseases, Male
Glucose Metabolism Disorders
Heart Diseases
Mental Disorders
Metabolic Diseases
Sexual and Gender Disorders
Sexual Dysfunctions, Psychological
Vascular Diseases

ClinicalTrials.gov processed this record on October 23, 2014