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Prospective clinical trial to elucidate the association between symptomatic atrial fibrillation and arterial stiffness and analysis of its clinical relevance

Conditions
Personality traitPerceptionRecurrence
I48
Atrial fibrillation and flutter
Registration Number
DRKS00019007
Lead Sponsor
niversitätsklinikum Mannheim
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete
Sex
All
Target Recruitment
168
Inclusion Criteria

male and female pts = 18 years, with atrial fibrillation, written informed consent

Exclusion Criteria

Unstable Angina pectoris / Acute Myocardial Infarction / Cardiogenic Shock
Indications for operative coronary revascularization (bypass surgery)
Stroke or TIA
Resting heart rate <50 beats per minute
Presence of a pacemaker / AICD and other metallic implants
Valve vitium with indication for surgery
Sick sinus syndrome, SA block, AV block III
Uncontrolled hypertension
Severe hypotension (<90 / 50mmHg)
Severe hepatic insufficiency
Patients with heart failure NYHA class III - IV
Pacemaker dependency

Study & Design

Study Type
observational
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Clinical symptoms (measurement method: questionnaire, interview)<br>Aortic distensibility (measurement method: echocardiography transthoracic / transesophageal)<br>Pulse wave velocity and augmentation index (measurement method: pulse wave analysis using a tonometrically recorded pulse curve).<br><br>The primary endpoint is collected only once at the beginning of the study.
Secondary Outcome Measures
NameTimeMethod
aboratory measured parameters for oxidative stress and inflammation (50 ml blood, 3xLi-Hep, 3xCitrate, 3xEDTA): VCAM-1, ICAM-1, MCP-1, TNF-alpha, IL-6, hs-CRP (measurement method: ELISA)<br><br>Personality trait (measurement method: questionnaire 5 BT, interview).<br><br>The secondary endpoint is collected only once at the beginning of the study.
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