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

10. august 2016 oppdatert av: Icahn School of Medicine at Mount Sinai

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.

Studieoversikt

Status

Fullført

Forhold

Detaljert beskrivelse

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.

Studietype

Observasjonsmessig

Registrering (Faktiske)

568

Kontakter og plasseringer

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Studiesteder

Forente stater
- New Jersey
  - Guttenberg, New Jersey, Forente stater, 07093
    - Hudson Heart Group
- New York
  - Elmhurst, New York, Forente stater, 11373
    - Elmhurst Hospital
  - Mineola, New York, Forente stater, 11501
    - Winthorp University Hospital
  - New York, New York, Forente stater, 10029
    - Icahn School of Medicine at Mount Sinai
  - Stony Brook, New York, Forente stater, 11794
    - Stony Brook University Hospital

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 75 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Mann

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

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

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Observasjonsmodeller: Kohort
Tidsperspektiver: Potensielle

Antall grupper / kohorter

Kohorter og intervensjoner

Gruppe / Kohort
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.

Hva måler studien?

Primære resultatmål

Resultatmål	Tiltaksbeskrivelse	Tidsramme
Composite outcome of all-cause mortality Tidsramme: up to 3 Years	The primary outcome is time to composite outcome of all-cause mortality, MI or stroke.	up to 3 Years

Sekundære resultatmål

Resultatmål	Tiltaksbeskrivelse	Tidsramme
To determine whether androgen status at baseline independently predicts primary and secondary endpoints in men (n=1,143) with DM and CAD. Tidsramme: Baseline	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.	Baseline
To determine whether erectile dysfunction at baseline independently predicts cardiovascular outcomes in men with DM and CAD. Tidsramme: Baseline	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.	Baseline
MACCE Tidsramme: at 6 months following catheterization	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.	at 6 months following catheterization
MACCE Tidsramme: at 12 months following catheterization	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.	at 12 months following catheterization
MACCE Tidsramme: at 18 months following catheterization	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.	at 18 months following catheterization
MACCE Tidsramme: at 24 months following catheterization	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.	at 24 months following catheterization
MACCE Tidsramme: at 30 months following catheterization	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.	at 30 months following catheterization
MACCE Tidsramme: at 36 months following catheterization	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.	at 36 months following catheterization

Samarbeidspartnere og etterforskere

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Sponsor

Icahn School of Medicine at Mount Sinai

Samarbeidspartnere

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. januar 2010

Primær fullføring (Faktiske)

1. juli 2016

Studiet fullført (Faktiske)

1. juli 2016

Datoer for studieregistrering

Først innsendt

24. august 2010

Først innsendt som oppfylte QC-kriteriene

27. august 2010

Først lagt ut (Anslag)

30. august 2010

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

11. august 2016

Siste oppdatering sendt inn som oppfylte QC-kriteriene

10. august 2016

Sist bekreftet

1. august 2016

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

GCO 06-0648
R01DK077954 (U.S. NIH-stipend/kontrakt)

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