Tokyo, Sept. 13 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062893) titled 'HFA-PEFF-Defined HFpEF Phenotype and Cardiac Remodeling With and Without Atrial Fibrillation Ablation' on Sept. 12.
Study Type:
Observational
Primary Sponsor:
Institute - Nihon University
Condition:
Condition - Nonvalvular atrial fibrillation with left ventricular ejection fraction >=40%
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To determine the prevalence and prognosis of the HFA-PEFF-defined HFpEF phenotype in patients with nonvalvular atrial fibrillation and a left ventricular ejection fraction of 40% or greater. We also aim to compare 1-year changes in HFA-PEFF scores and cardiac remodeling between patients with and without catheter ablation and to explore their associations with clinical outcomes.
Basic objectives2 - Others
Eligibility:
Age-lower limit - 20
years-old
<=
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - 1. Patients aged 20 years or older with nonvalvular atrial fibrillation
2. Patients undergoing regular outpatient follow-up
3. Left ventricular ejection fraction greater than 40%
4. Written informed consent to participate in the study
Key exclusion criteria - 1. Severe frailty defined as a Clinical Frailty Scale score of 8 or higher
2. Severe valvular heart disease
3. Active malignancy
4. Patients considered inappropriate for participation by the principal investigator or study investigators
Target Size - 1500
Recruitment Status:
Recruitment status - No longer recruiting
Date of protocol fixation - 2024 Year 02 Month 03 Day
Date of IRB - 2024 Year 03 Month 14 Day
Anticipated trial start date - 2024 Year 04 Month 26 Day
Last follow-up date - 2026 Year 10 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072014
Disclaimer: Curated by HT Syndication.
