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Effects of pharmacological treatments in heart failure with preserved ejection fractio

Phase 2
Recruiting
Conditions
Heart failure with preserved ejection fraction
Registration Number
JPRN-jRCT1031220336
Lead Sponsor
Obokata Masaru
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
125
Inclusion 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

Exclusion 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
s
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

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Change in estimated pulmonary artery systolic pressure during peak exercise 2-4 months after the intervention
Secondary Outcome Measures
NameTimeMethod
1) Changes in hemodynamics, cardiovascular reserve, and peak oxygen consumption 2-4 months after the intervention<br>2) Association between the intervention and outcome<br>3) Association between changes in hemodynamics, cardiovascular reserve, and peak oxygen consumption 2-4 months after the intervention and outcome<br>*: outcome=a composite of all-cause death, heart failure events (hospitalization or unplanned visit requiring iv diuretics)
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