Association of Multiple CardiOvascular Risk Factors and Erectile Function Across Europe

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00468637

Acronym

AMORE-Eur

Enrollment

1200

Registered

2007-05-03

Start date

2007-05-31

Completion date

2011-09-30

Last updated

2009-02-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular High-Risk, Chronic Heart Failure

Keywords

heart failure, cardiovascular high risk, erectile dysfunction, cardiovascular disease

Brief summary

The purpose of the study is to evaluate the influence of cardiovascular risk factors, heart failure and cardiovascular drug therapy on erectile function in cardiovascular high-risk patients.

Detailed description

Association of cardiovascular risk factors and ED is likely due to an impairment of endothelial function resulting in a decreased activity of endothelial NO-synthase, which plays a major role in physiology of erection. Heart failure is also known to further contribute to endothelial dysfunction and hence, this could lead to erectile dysfunction. Study Objectives 1. Evaluation of the influence of cardiovascular risk factors and concomitant medication on erectile function in cardiovascular high-risk patients. 2. Evaluation of the role of heart failure on prevalence and severity of erectile dysfunction in men. 3. Long-term effects of cardiovascular drug therapy and cardiovascular diseases on erectile function. Study Design Male patients across Europe with cardiovascular diseases (CHD, PAD and heart failure) will be evaluated with a standardized questionnaire. Grade of erectile dysfunction will be assessed using an ED-score, generated from two different questionnaires. 1. IIEF-5 - (International Index of Erectile Function) 2. KEED - (Cologne Evaluation of Erectile Dysfunction) Primary Endpoint The primary endpoint is the sum score of the ED rating scale of the KEED (Kölner Erhebungsbogen zur Erektilen Dysfunktion, see Appendix 1). Erectile dysfunction is defined as reaching more than 17 points in the sum score. Secondary Endpoint The first secondary endpoint is the frequency of sexual activity and sexual desire. Another secondary endpoint contains satisfaction with sex life and general well-being. Men are defined as dissatisfied by answering mixed or worse. Follow-Up: after 1 year, after 2 years.

Interventions

None listed

Study design

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

MALE

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Male patients with two or more cardiovascular risk factors or * Male patients with a manifestation of atherosclerosis or * Male patients with an ischemic or dilated cardiomyopathy * Written informed consent

Exclusion criteria

* Impairment of hormonal status * Refusal of written informed consent * Inability to complete the questionnaires

Countries

Germany, Italy, Poland

Contacts

Primary ContactMichael Böhm, MD

michael.boehm@uniklinikum-saarland.de0049-6841-16-

Backup ContactMagnus Baumhäkel, MD

magnus@baumhaekel.de0049-6841-16-

Outcome results