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

10 de agosto de 2016 atualizado por: 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.

Visão geral do estudo

Status

Concluído

Condições

Descrição detalhada

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.

Tipo de estudo

Observacional

Inscrição (Real)

568

Contactos e Locais

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Locais de estudo

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

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos a 75 anos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Macho

Método de amostragem

Amostra Não Probabilística

População do estudo

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

Descrição

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.

Plano de estudo

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Como o estudo é projetado?

Detalhes do projeto

Modelos de observação: Coorte
Perspectivas de Tempo: Prospectivo

Número de grupos/coortes

Coortes e Intervenções

Grupo / Coorte
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.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado	Descrição da medida	Prazo
Composite outcome of all-cause mortality Prazo: up to 3 Years	The primary outcome is time to composite outcome of all-cause mortality, MI or stroke.	up to 3 Years

Medidas de resultados secundários

Medida de resultado	Descrição da medida	Prazo
To determine whether androgen status at baseline independently predicts primary and secondary endpoints in men (n=1,143) with DM and CAD. Prazo: 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. Prazo: 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 Prazo: 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 Prazo: 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 Prazo: 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 Prazo: 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 Prazo: 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 Prazo: 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

Colaboradores e Investigadores

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Patrocinador

Icahn School of Medicine at Mount Sinai

Colaboradores

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

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo

1 de janeiro de 2010

Conclusão Primária (Real)

1 de julho de 2016

Conclusão do estudo (Real)

1 de julho de 2016

Datas de inscrição no estudo

Enviado pela primeira vez

24 de agosto de 2010

Enviado pela primeira vez que atendeu aos critérios de CQ

27 de agosto de 2010

Primeira postagem (Estimativa)

30 de agosto de 2010

Atualizações de registro de estudo

Última Atualização Postada (Estimativa)

11 de agosto de 2016

Última atualização enviada que atendeu aos critérios de controle de qualidade

10 de agosto de 2016

Última verificação

1 de agosto de 2016

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

GCO 06-0648
R01DK077954 (Concessão/Contrato do NIH dos EUA)

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