Impact of rhythm control in patients with HFpEF and atrial fibrillation

JRCT ID: jRCT1032220117

Registered date:04/06/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Heart failure with preserved ejection fraction
• Date of first enrollment: 08/07/2021
• Target sample size: 250
• Study type: Interventional

Intervention(s)

1) Exercise stress echocardiography with expired gas analysis
2) Blood sampling from left atrium

Outcome(s)

• Primary Outcome: Change in peak oxygen consumption or cardiovascular reserve function during exercise stress echocardiography from baseline to six-month after the rhythm control therapy
• Secondary Outcome: Association between the success of rhythm control therapy and outcomes

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1) Age equal to or more than 20 years old
2) Patients with EF of 50% or >50%
3) Patients with established HFpEF or subjects who are suspected of HFpEF
4) Subjects who are planned to be treated with rhythm control therapy for atrial fibrillation
5) Patients who give written consent to participate in this study

Exclude criteria

1) Patients with complications contraindicated for exercise testing (acute decompensated heart failure, history of left ventricular ejection fraction less than 40%, non-group II pulmonary hypertension, more than mild aortic or mitral valve stenosis, more than moderate aortic or mitral valve regurgitation, cardiomyopathy, acute coronary syndrome, complicated adult congenital heart disease)
2) Patients who cannot exercise their legs due to abnormalities in joints, muscles, etc.
3) Patients who are judged to be unsuitable for the study by the investigators

Related Information

• Primary Sponsor: Obokata Masaru