Trial document





This trial has been registered retrospectively.
drksid header

  DRKS00019007

Trial Description

start of 1:1-Block title

Title

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

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

PANDA (Perception of Atrial Fibrillation iN Dependence of Arterial Stiffness)

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

http://not available

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

Atrial fibrillation (AF) occurs in 1-2% of the population and thus represents the most common cardiac arrhythmia; about six million people in Europe are suffering from AF. In the normal state, which means in sinus rhythm, the atria and ventricles of the heart are stimulated immediately one after another about 70 times per minute. The muscle contraction of the atria leads to an additional blood filling of the chambers, which also contract about 150 milliseconds later. However, in atrial fibrillation, undirected electrical excitations pass through the atria. This leads to rapid and disorderly movements of the walls at a frequency of 300 to 600 per minute.
Atrial fibrillation is associated with an increased risk of thromboembolism; the mortality rate is also increased; The quality of life of affected patients can also be significantly influenced. To better understand the etiology of this cardiac arrhythmia for current and future patients, this study is being conducted.
Timely evaluation of the possible triggers that could underlie the cardiac arrhythmia can help initiate appropriate causal therapy and / or have a beneficial effect on life expectancy and quality and potentially prevent serious complications.
We are interested why some patients are symptomatic, which means they feel the fibrillation of the atria (often a very unpleasant skipped heartbeat or tachycardia) and others do not (asymptomatic = no symptoms). For this reason, we want to investigate the relationship between increased vascular stiffness and (absence) presence of atrial fibrillation symptoms in this study. On the other hand, we want to use a questionnaire to find out whether patients with a neurotic personality structure are more likely to feel atrial fibrillation.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

The possible association between aortic stiffness and the symptoms of atrial fibrillation has not been investigated yet in humans.
This study examines patients with (a-)symptomatic atrial fibrillation and compares the vascular parameters such as arterial stiffness of these with the vascular parameters of patients with asymptomatic atrial fibrillation. The study therefore tests the hypothesis that there is an association between symptomatic atrial fibrillation and arterial vascular stiffness. Against the background of the alternative hypothesis, a standardized questionnaire is used to investigate whether there is a connection between a neurotic (compulsive) personality structure and symptomatic atrial fibrillation.

end of 1:1-Block scientific synopsis
start of 1:1-Block forwarded Data

Do you plan to share individual participant data with other researchers?

[---]*

end of 1:1-Block forwarded Data
start of 1:1-Block forwarded Data Content

Description IPD sharing plan:

[---]*

end of 1:1-Block forwarded Data Content
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00019007
  •   2019/11/14
  •   [---]*
  •   yes
  •   Approved
  •   2016-649N-MA, Medizinische Ethik-Kommission II Medizinische Fakultät Mannheim der Universität Heidelberg
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  • [---]*
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   I48 -  Atrial fibrillation and flutter
  •   Personality trait
    Perception
    Recurrence
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Asymptomatic to oligosymptomatic patients (EHRA I-IIa).

    Within the clincial routine a transesophageal echocardiography procedure was performed before cardioversion/ pulmonary vein isolation in order to exclude intracardiac thrombi. In addition, a tonometric recording of the pulse curve and a blood sample was performed.
    Furthermore, questionnaires are used to record clinical parameters as well as for evaluation of the personality trait.

    This study consists of a parallel design that compares both groups. Accordingly, both groups receive the same intervention / examination.
    The examinations take place once at the beginning of the study.
  •   Symptomatic patients (EHRA ≥ IIb):

    Within the clincial routine a transesophageal echocardiography procedure was performed before cardioversion/ pulmonary vein isolation in order to exclude intracardiac thrombi. In addition, a tonometric recording of the pulse curve and a blood sample was performed.
    Furthermore, questionnaires are used to record clinical parameters as well as for evaluation of the personality trait.

    This study consists of a parallel design that compares both groups. Accordingly, both groups receive the same intervention / examination.
    The examinations take place once at the beginning of the study.
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Non-interventional
  •   Other
  •   Non-randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Other
  •   Prevention
  •   Parallel
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

Clinical symptoms (measurement method: questionnaire, interview)
Aortic distensibility (measurement method: echocardiography transthoracic / transesophageal)
Pulse wave velocity and augmentation index (measurement method: pulse wave analysis using a tonometrically recorded pulse curve).

The primary endpoint is collected only once at the beginning of the study.

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

Laboratory 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)

Personality trait (measurement method: questionnaire 5 BT, interview).

The secondary endpoint is collected only once at the beginning of the study.

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • Medical Center 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2017/03/01
  •   170
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

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

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

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

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Universitätsklinikum Mannheim
    • Theodor-Kutzer-Ufer 1-3
    • 68167  Mannheim
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address scientific-contact
    • Universitätsklinikum Mannheim I. Medizinische Klinik - Kardiologie
    • Ms.  Dr. med.  Anna  Hohneck 
    • Theodor-Kutzer-Ufer 1-3
    • 68167  Mannheim
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Universitätsklinikum Mannheim I. Medizinische Klinik - Kardiologie
    • Ms.  Dr. med.  Anna  Hohneck 
    • Theodor-Kutzer-Ufer 1-3
    • 68167  Mannheim
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Universitätsklinikum MannheimI. Medizinische Klinik - Kardiologie
    • Ms.  Dr. med.  Anna  Hohneck 
    • Theodor-Kutzer-Ufer 1-3
    • 68167  Mannheim
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting complete, follow-up complete
  •   2019/04/01
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  •   Prüfplan
end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.