Cardiovascular High-RiskAMORE-EurNCT00468637
Association of Multiple CardiOvascular Risk Factors and Erectile Function Across Europe
An observational study of Cardiovascular High-Risk and Chronic Heart Failure, run by University Hospital, Saarland at 4 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Cardiovascular High-Risk, Chronic Heart Failure
- How many people
- 1,200 participants
- Where
- 4 sitesin 3 countries
- Study dates
- May 2007to Sep 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: primary care clinic, outpatient department, general practitioner
Who may be able to join
- 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
Who cannot join
- Impairment of hormonal status
- Refusal of written informed consent
- Inability to complete the questionnaires
Trial locations and contacts
4 sites in 3 countries.
4 sites in 3 countries
Germany2 sites, 2 recruiting
- Recruiting
Department of Cardiology, University Hospital of the Saarland
Homburg, Saarland, 66421
Magnus Baumhäkel, MD, 0049-6841-16 ext. 23000, magnus@baumhaekel.de
Magnus Baumhäkel, MD
- Recruiting
Gemeinschaftspraxis & Ambulante Tagesklinik
Merzig-Schwemlingen, Saarland, 66663
Volker Rettig-Ewen, MD, 0049-6861 ext. 992902, praxis@rettig-ewen.de
Volker Rettig-Ewen, MD
Italy1 site, 1 recruiting
- Recruiting
Section on Cardiovascular Diseases, Department of Experimental and Applied Medicine, University of Brescia
Brescia
Alberto Saporetti, MD, alberto@funkgogh.it
Marco Metra, MD
Poland1 site, 1 recruiting
- Recruiting
Department of Cardiology, 4th Military Clinical Hospital
Wroclaw
Ewa A Jankowska, MD, ewa@antro.pan.wroc.pl
Piotr Ponikowski, MD
About this study
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.
Read the 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
- Evaluation of the influence of cardiovascular risk factors and concomitant medication on erectile function in cardiovascular high-risk patients.
- Evaluation of the role of heart failure on prevalence and severity of erectile dysfunction in men.
- 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.
- IIEF-5 - (International Index of Erectile Function)
- 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.
- Conditions
- Cardiovascular High-Risk, Chronic Heart Failure
- Keywords
- heart failure, cardiovascular high risk, erectile dysfunction, cardiovascular disease
- Medical subject headings
- Heart Failure, Erectile Dysfunction, Cardiovascular Diseases
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2007 (estimated)
- Study startMay 2007
- Study completionSep 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular High-RiskStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Saarland
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Investigators
- Michael Böhm, MD, Principal investigator, Department of Cardiology, University Hospital of the SaarlandMagnus Baumhäkel, MD, Principal investigator, Department of Cardiology, University Hospital of the Saarland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00468637
- Sponsor's protocol ID
- 133/04
- Acronym
- AMORE-Eur
- Status last verified
- Feb 2009
- First submitted
- 2 May 2007
- Last updated
- 16 Feb 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Rosen RC, Cappelleri JC, Smith MD, Lipsky J, Pena BM. Development and evaluation of an abridged, 5-item version of the International Index of Erectile Function (IIEF-5) as a diagnostic tool for erectile dysfunction. Int J Impot Res. 1999 Dec;11(6):319-26. doi: 10.1038/sj.ijir.3900472.
PubMed 10637462Braun M, Wassmer G, Klotz T, Reifenrath B, Mathers M, Engelmann U. Epidemiology of erectile dysfunction: results of the 'Cologne Male Survey'. Int J Impot Res. 2000 Dec;12(6):305-11. doi: 10.1038/sj.ijir.3900622.
PubMed 11416833Petrone L, Mannucci E, Corona G, Bartolini M, Forti G, Giommi R, Maggi M. Structured interview on erectile dysfunction (SIEDY): a new, multidimensional instrument for quantification of pathogenetic issues on erectile dysfunction. Int J Impot Res. 2003 Jun;15(3):210-20. doi: 10.1038/sj.ijir.3901006.
PubMed 12904808
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of Multiple CardiOvascular Risk Factors and Erectile Function Across Europe
- ClinicalTrials.gov ID
- NCT00468637
- Acronym / sponsor ID
- AMORE-Eur / 133/04
- Conditions
- Cardiovascular High-Risk, Chronic Heart Failure
- Keywords
- heart failure, cardiovascular high risk, erectile dysfunction, cardiovascular disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- University Hospital, SaarlandUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- May 2007
- Study completion
- Sep 2011 (estimated)
- First posted
- 3 May 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Evaluation of the influence of cardiovascular risk factors and concomitant medication on erectile function in cardiovascular high-risk patients.
- Evaluation of the role of heart failure on prevalence and severity of erectile dysfunction in men.
- 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.
- IIEF-5 - (International Index of Erectile Function)
- 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.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- primary care clinic, outpatient department, general practitioner
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Impairment of hormonal status
- Refusal of written informed consent
- Inability to complete the questionnaires
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2009.
- Background: PubMed 10637462Rosen RC, Cappelleri JC, Smith MD, Lipsky J, Pena BM. Development and evaluation of an abridged, 5-item version of the International Index of Erectile Function (IIEF-5) as a diagnostic tool for erectile dysfunction. Int J Impot Res. 1999 Dec;11(6):319-26. doi: 10.1038/sj.ijir.3900472.
- Background: PubMed 11416833Braun M, Wassmer G, Klotz T, Reifenrath B, Mathers M, Engelmann U. Epidemiology of erectile dysfunction: results of the 'Cologne Male Survey'. Int J Impot Res. 2000 Dec;12(6):305-11. doi: 10.1038/sj.ijir.3900622.
- Background: PubMed 12904808Petrone L, Mannucci E, Corona G, Bartolini M, Forti G, Giommi R, Maggi M. Structured interview on erectile dysfunction (SIEDY): a new, multidimensional instrument for quantification of pathogenetic issues on erectile dysfunction. Int J Impot Res. 2003 Jun;15(3):210-20. doi: 10.1038/sj.ijir.3901006.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Böhm, MD principal investigator
Department of Cardiology, University Hospital of the Saarland
Magnus Baumhäkel, MD principal investigator
Department of Cardiology, University Hospital of the Saarland
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular High-Risk and Chronic Heart Failure, run by University Hospital, Saarland at 4 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Germany, Italy, Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michael Böhm, MD (0049-6841-16- ext. 23000, michael.boehm@uniklinikum-saarland.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00468637, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2009.