Danderyd Hospital
Stockholm, Sweden
Location status: Recruiting
Location contact
Johan Engdahl
CONTACT
Piotr Sobocinski Doliwa, M.D. Ph.D.
CONTACT
NCT Number: NCT05080712
The purpose of this study is to investigate the presence and magnitude of structural changes of the heart and their long-term development in young patients with atrial Fibrillation (AF), studied by echocardiographic measurements and plasma biomarkers and their association to AF burden, studied using long-term ECG
Interested in participating?
Request Info18 year–50 year
All sexes
Observational
Stockholm, Sweden
Location status: Recruiting
Johan Engdahl
CONTACT
Piotr Sobocinski Doliwa, M.D. Ph.D.
CONTACT
100 patients with symptomatic Atrial Fibrillation diagnosis are included. Diagnosis is set either at the index visit or within 12 months before inclusion. . The follow up period is 5 years. Patients presenting with AF in connection with acute infection, acute cardiac ischemia, surgery or thyroid disease are excluded. Further, AF patients with cardiomyopathies, known genetic diseases and congenital cardiac abnormalities are also excluded.
At inclusion patients undergo an in-depth interview regarding comorbidities, medication, previous treatments related to the AF diagnosis. In addition, baseline data for weight and height are collected.
In connection to inclusion the patients are asked leave venous bloodwork (Na, K, Creatinine, plasma Glucose and NTproB-Type Natriuretic Peptide). An echocardiographic exam is performed according to a prespecified protocol with special emphasis on the left atrial function and anatomy. This is followed by a continuous ECG recording for 14 days using BioTel ePatch. The ECG patch is later returned to a core facility by mail.
The patients´ are followed for five years and are asked to leave bloodwork and perform a 14-day ECG recording yearly. After these exams, a follow up phone call is placed to the patient aimed at documenting clinical progress related to symptoms, treatment and interventions. After 5 years follow up patients undergo a follow up echocardiographic exam in addition to yearly bloodwork and ECG recording. The patients´ clinical symptoms are treated at the clinician´s discretion according to current guidelines.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: change from baseline at 5 years
Change in burden of atrial fibrillation expressed as proportion of arrhythmia present on long-term ECG yearly
Time frame: Change from baseline at 5 years
Change in levels of plasma-N-terminal pro brain natriuretic peptide yearly (ng)
Time frame: Change from baseline at 5 years
Change in number of supraventricular ectopic beats per 24 h on long-term ECG Yearly
Time frame: Change from baseline at 5 years
Change in numbers of supraventricular tachycardia runs of at least 20 beats per 24 h on long-term ECG yearly
Time frame: Change from baseline at 5 years
Change in numbers of atrial fibrillation episodes per 24 h on long-term ECG yearly
Time frame: Change from baseline at 5 years
Change in the left atrial volume indexed (ml/m2)
Time frame: Change from baseline at 5 years
Change in left atrial strain (%)
Time frame: Change from baseline at 5 years
Change in left ventricular volume indexed (ml/m2)
Time frame: Change from baseline at 5 years
Change in left ventricular ejection fraction (%)
Contact information is provided by the study sponsor or research team.
Johan Engdahl, MD PhD
CONTACT
Piotr Sobocinski Doliwa, M.D. Ph.D.
CONTACT
Karolinska Institutet
Other
Acronym: PRAY
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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