Effects of pharmacological treatments in heart failure with preserved ejection fraction

JRCT ID: jRCT1031220336

Registered date:14/09/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Heart failure with preserved ejection fraction
• Date of first enrollment: 14/09/2022
• Target sample size: 125
• Study type: Interventional
• Intervention(s): Exercise stress echocardiography with simultaneous peripheral venous pressure measurement and expired gas analysis

Outcome(s)

• Primary Outcome: Change in estimated pulmonary artery systolic pressure during peak exercise 2-4 months after the intervention

Secondary Outcome

1) Changes in hemodynamics, cardiovascular reserve, and peak oxygen consumption 2-4 months after the intervention
2) Association between the intervention and outcome
3) Association between changes in hemodynamics, cardiovascular reserve, and peak oxygen consumption 2-4 months after the intervention and outcome
*: outcome=a composite of all-cause death, heart failure events (hospitalization or unplanned visit requiring iv diuretics)

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 more than 50%
3) Patients with established HFpEF or subjects who are suspected of HFpEF
4) Patients with possible new initiation of medications such as empagliflozin, sacubitril valsartan, or spironolactone.
5) Patients who give written consent to participate in this study

Exclude criteria

1) Patients with mimic HFpEF: Decompensated heart failure, history of EF less than 40%, pulmonary arterial hypertension, more than mild aortic or mitral valve stenosis, more than moderate aortic or mitral valve regurgitation, cardiomyopathy, acute coronary syndrome, complex adult congenital heart disease
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2) Subjects who cannot keep cycle ergometry exercise (0 watts) for more than 30 seconds
3) Patients who are judged to be unsuitable for the study by the investigators

Related Information

• Primary Sponsor: Obokata Masaru