UMIN-ICDS Clinical Trial

Public title

Single-center prospective observational study investigating the impact of chronic inflammation on drug responsiveness in heart failure patients

Acronym

Observational study of heart failure patients with chronic inflammation

Scientific Title

Single-center prospective observational study investigating the impact of chronic inflammation on drug responsiveness in heart failure patients

Scientific Title:Acronym

Observational study of heart failure patients with chronic inflammation

Region

Japan

Condition

Chronic heart failure

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

YES

Narrative objectives1

Chronic inflammation is known to be involved in the pathogenesis of heart failure. The purpose of this study is to investigate the association between the degree of chronic inflammation and the efficacy of drug therapy in heart failure patients.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Hospitalization due to exacerbation of heart failure

Key secondary outcomes

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

Purpose of intervention

Type of intervention

Interventions/Control_1

Interventions/Control_2

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

18

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

Patients newly prescribed the following drugs for heart failure at Hamamatsu University Hospital
Beta-blocker
SGLT2 inhibitor
Angiotensin receptor neprilysin inhibitor
Mineralocorticoid receptor antagonist

Key exclusion criteria

Patients who have had a heart failure event within the past 4 weeks
Patients with infectious diseases
Patients with cancer
Patients with significantly poor medication adherence

Target sample size

100

Name of lead principal investigator

1st name	Junichi
Middle name
Last name	Kawakami

Organization

Hamamatsu University School of Medicine

Division name

Hospital Pharmacy

Zip code

431-3192

Address

1-20-1 Handayama, Chuo-ku, Hamamatsu City, Shizuoka Prefecture

TEL

053-435-2767

Email

kojisuzu@hama-med.ac.jp

Name of contact person

1st name	Koji
Middle name
Last name	Suzuki

Organization

Hamamatsu University School of Medicine

Division name

Hospital Pharmacy

Zip code

431-3192

Address

1-20-1 Handayama, Chuo-ku, Hamamatsu City, Shizuoka Prefecture

TEL

053-435-2767

Homepage URL

Email

kojisuzu@hama-med.ac.jp

Institute

Hamamatsu University School of Medicine

Institute

Department

Personal name

Organization

Hamamatsu University School of Medicine

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Ethics Committee of Hamamatsu University School of Medicine (EC HUSM)

Address

1-20-1 Handayama, Chuo-ku, Hamamatsu City, Shizuoka Prefecture

Tel

053-435-2680

Email

rinri@hama-med.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

浜松医科大学医学部附属病院

Date of disclosure of the study information

2024

Year

04

Month

05

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Open public recruiting

Date of protocol fixation

2023

Year

11

Month

01

Day

Date of IRB

2023

Year

12

Month

04

Day

Anticipated trial start date

2024

Year

04

Month

01

Day

Last follow-up date

2030

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Study Design
Single-center prospective observational study

Inclusion criteria
Patients newly injected with SGLT2 inhibitors (dapagliflozin, empagliflozin)
Patients newly started on ARNI (sacubitril valsartan) (including switching from ARB/ACEi)
Patients with no heart failure exacerbation events within the last 4 weeks
(*Outpatients must be enrolled as outpatients, but inpatients who do not meet the following exclusion criteria will be included in the study.)

Exclusion criteria
Patients with acute conditions that cause severe inflammation such as infection
Patients with a heart failure exacerbation event within 4 weeks prior to the initiation of heart failure therapy.
Patients with extremely poor drug compliance
Patients with cancer
Patients with a history of autoimmune disease.

Main endpoints of the observational study
To achieve stratification of HFpEF patients based on quantitative profiles of inflammatory markers and RAA-related peptides at the time of introduction of SGLT2i/ARNI (classification into 3 or 4 clusters is assumed).
Comparison of heart failure events (unscheduled visits, hospitalizations) among the stratified clusters
Comparison of improvement of heart failure markers (NT-proBNP, soluble ST2, etc.) between stratified clusters

Registered date

2024

Year

04

Month

04

Day

Last modified on

2024

Year

04

Month

04

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061718