Association of Multiple CardiOvascular Risk Factors & Erectile Function

Status Recruiting

Clinical 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.

Clinical Trial 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. ;

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00468637
Study type	Observational
Source	University Hospital, Saarland
Contact	Michael Böhm, MD
Phone	0049-6841-16-
Email	michael.boehm@uniklinikum-saarland.de
Status	Recruiting
Phase	N/A
Start date	May 2007
Completion date	September 2011

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT03597646` - The Effect of Kinesio Taping on Pulmonary Function and Functional Capacity in Patients With Chronic Heart Failure	N/A
Terminated	`NCT04065997` - Apogee International
Withdrawn	`NCT03675113` - Effect of Upper Extremity Aerobic Exercise Training on Exercise Capacity Patients With Chronic Heart Failure	N/A
Completed	`NCT02916160` - Sacubitril-valsartan and Heart Failure Patients : the ENTRESTO-SAS Study	Phase 4
Completed	`NCT03126656` - Effects of Testosterone on Myocardial Repolarization	Phase 4
Completed	`NCT02247245` - The Influence of Heart Rate Limitation on Exercise Tolerance in Pacemaker Patients.	N/A
Completed	`NCT02268500` - VAccination to Improve Clinical outComes in Heart Failure Trial: a Feasibility Study (VACC-HeFT)	Phase 4
Completed	`NCT01919918` - Muscle Afferent Feedback Effects in Patients With Heart Failure	Phase 1
Terminated	`NCT01906957` - Cognition and Exercise Training	N/A
Not yet recruiting	`NCT01669395` - Severe Heart Failure and Homebased Rehabilitation - An Intersectoral Randomized Controlled Trial	N/A
Completed	`NCT00984529` - Evaluation of Clinical Signs and Symptoms of Chronic Heart Failure in Patients Treated With Candesartan Cilexetil in Croatia	N/A
Recruiting	`NCT00863421` - Sleep Disordered Breathing in Patients With Chronic Heart Failure	N/A
Completed	`NCT02840565` - Tolerability, Pharmacokinetics and Pharmacodynamics of Six Multiple Rising Dose Regimens of BIA 5-453	Phase 1
Completed	`NCT02441218` - Effects of Ivabradine on Cardiovascular Events in Patients With Moderate to Severe Chronic Heart Failure and Left Ventricular Systolic Dysfunction. A Three-year International Multicentre Study	Phase 3
Completed	`NCT00149409` - Omega-3-Polyunsaturated Fatty-Acids (N3-Pufa) In Patients With Severe Chronic Heart Failure	Phase 2/Phase 3
Terminated	`NCT05532046` - A Study to Learn How Safe Study Drug BAY2413555 is, How it Affects the Body, and How it Moves Into, Through, and Out of the Body Over 4 Weeks of Use in Participants With Heart Failure and Implanted Cardiac Defibrillator or Cardiac Resynchronization Devices (ICD/CRT)	Phase 1
Recruiting	`NCT04984928` - Readmission Risk of Patients With Heart Failure.
Completed	`NCT02814097` - A Study to Evaluate the Effects of 4 Weeks Treatment With Subcutaneous Elamipretide on Left Ventricular Function in Subjects With Stable Heart Failure With Preserved Ejection Fraction	Phase 2
Active, not recruiting	`NCT05560737` - ODYSSEE-vCHAT Mental Health Program for Heart Failure and Kidney Disease Patients
Recruiting	`NCT03286127` - Palliative Outcome Evaluation Muenster I

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Association of Multiple CardiOvascular Risk Factors and Erectile Function Across Europe — AMORE-Eur

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms