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Effects of pharmacological treatments in heart failure with preserved ejection fraction

Effects of pharmacological treatments on hemodynamics, cardiovascular reserve, exercise tolerance, and prognosis in heart failure with preserved ejection fraction - Effects of pharmacological treatments on hemodynamics, cardiovascular reserve, exercise tolerance, and prognosis in heart failure with preserved ejection fraction

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT1031220336
Enrollment
125
Registered
2022-09-14
Start date
2022-09-14
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart failure with preserved ejection fraction

Interventions

Exercise stress echocardiography with simultaneous peripheral venous pressure measurement and expired gas analysis

Sponsors

Obokata Masaru
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Change in estimated pulmonary artery systolic pressure during peak exercise 2-4 months after the intervention

Secondary

MeasureTime frame
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)

Contacts

Public ContactTomonari Harada

Gunma University Hospital

tharada@gunma-u.ac.jp+81-27-220-8145

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026