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Registry of contemporary medical management of chronic heart failure with non-reduced ejection fraction in Japan

Registry of contemporary medical management of chronic heart failure with non-reduced ejection fraction in Japan - The PARACLETE study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000046951
Enrollment
4200
Registered
2022-02-20
Start date
2022-02-21
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

HF with non-reduced EF (HF non-rEF

Interventions

None listed

Sponsors

NARA medical university
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1)Older than 20 years old 2)Fully understand the research content and have indicated their intention to cooperate in the research in writing. 3)Medical regimen of heart failure-related treatment (both pharmacotherapy and non-pharmacotherapy) was not changed at least the last 8 weeks 4)LVEF of higher than 40% (not including 40%) and less than 50% with transthoracic echocardiography performed within the last 12 months. 5) LVEF of 50% or more with transthoracic echocardiography performed within the last 12 months and meet at least one of the following conditions A or B. A: A history of HF hospitalization B: No history of HF hospitalization but meets either following a or b . (Values in parentheses are for patients with atrial fibrillation.) a. [BNP level of 100 (200) pg/ml or more] or [NT-proBNP level of 400 (800) pg/ml or more] b. [BNP level of 40 (80) pg/ml or more and less than 100 (200) pg/ml] or [NT-proBNP level of 125 (250) pg/ml or more and less than 400 (800) pg/ml], and meet at least one of following I to VI of echocardiographic criteria I. Interventricular septum or posterior wall thickness: 11 mm or more II. Left atrium diameter: 38 mm or more III. Left atrium length: 50 mm or more IV. Left atrium area: 20 cm2 or more V. Left atrium volume: 55 ml or more VI. Left atrium volume index: 29 ml / m2 or more

Exclusion criteria

Exclusion criteria: 1) Severe renal dysfunction such as the latest eGFR of less than 15 ml / min / 1.73 m2 or during dialysis 2) Changed their heart failure-related treatment (both pharmacotherapy and non-pharmacotherapy) within 8 weeks from registration 3) Require urgent hospitalization due to heart failure 4). Confirmed diagnosis of cardiac amyloidosis and dilated cardiomyopathy 5. Confirmed diagnosis of obstructive hypertrophic cardiomyopathy and hypertrophic cardiomyopathy with a family history 6. Recover EF who have been pointed out that LVEF is 40% or less in the past 7. Pulmonary arterial hypertension 8. Severe liver disease or lung disease 9. Cancer with a prognosis of less than 1 year 10. Staying in Long-Term Care Health Facility or hospice 11. Participating in some interventional study

Design outcomes

Primary

MeasureTime frame
1.Proportion of patients with HF non-rEF were changed at the enrollment, and categories of reasons for the changing prescription at enrollment 2.A composite of unexpected HF hospitalization and all-cause death in a 2-year follow up

Countries

Japan

Contacts

Public ContactTomoya Ueda

Nara Medical University Hospital Department of Cardiovascular Medicine

tom15@naramed-u.ac.jp0744-22-3051

Outcome results

None listed

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