UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034852 |
|---|---|
| Receipt number | R000039742 |
| Scientific Title | Prevalence of Heart Diseases in Patients with Interstitial Lung Disease (ILD-HEART study) |
| Date of disclosure of the study information | 2018/12/20 |
| Last modified on | 2025/10/15 13:28:09 |
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Basic information
Public title
Prevalence of Heart Diseases in Patients with Interstitial Lung Disease (ILD-HEART study)
Acronym
ILD HEART study
Scientific Title
Prevalence of Heart Diseases in Patients with Interstitial Lung Disease (ILD-HEART study)
Scientific Title:Acronym
ILD HEART study
Region
| Japan |
Condition
Condition
Interstitial lung disease
Classification by specialty
| Medicine in general | Cardiology | Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the prevalence of heart diseases (coronary artery disease, arrhythmia, heart failure) in patients with interstitial lung disease
Basic objectives2
Others
Basic objectives -Others
To compare the prevalence from this study and data from previous epidemiological studies (Framingham study, MESA study etc.)
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
prevalence of heart diseases (coronary artery disease, arrhythmia, heart failure)
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
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
Eligibility
Age-lower limit
| 20 | years-old | < |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients with Interstitial lung disease who visited our hospital
Key exclusion criteria
None
Target sample size
2000
Research contact person
Name of lead principal investigator
| 1st name | Shingo |
| Middle name | |
| Last name | Kato |
Organization
Kanagawa Cardiovascular and Respiratory Center
Division name
Department of Cardiology
Zip code
236-0051
Address
6 Chome-16-1 Tomiokahigashi, Kanazawa, Yokohama, Kanagawa Prefecture
TEL
045-701-9581
shingo.m12226@gmail.com
Public contact
Name of contact person
| 1st name | Shingo |
| Middle name | |
| Last name | Kato |
Organization
Kanagawa Cardiovascular and Respiratory Center
Division name
Department of Cardiology
Zip code
236-0051
Address
6 Chome-16-1 Tomiokahigashi, Kanazawa, Yokohama, Kanagawa Prefecture
TEL
045-701-9581
Homepage URL
shingo.m12226@gmail.com
Sponsor or person
Institute
Kanagawa Cardiovascular and Respiratory Center
Institute
Department
Personal name
Funding Source
Organization
Kanagawa Cardiovascular and Respiratory Center
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kanagawa Cardiovascular and Respiratory Center, IRB
Address
6-16-1, Tomiokahigashi, Yokohama, Kanagawa
Tel
045-701-9581
shingo.m12226@gmail.com
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 12 | Month | 20 | Day |
Related information
URL releasing protocol
https://link.springer.com/article/10.1007/s00380-021-01787-1
Publication of results
Published
Result
URL related to results and publications
https://link.springer.com/article/10.1007/s00380-021-01787-1
Number of participants that the trial has enrolled
1358
Results
This study examined the prevalence and prognostic impact of coronary artery disease (CAD) and heart failure (HF) in idiopathic pulmonary fibrosis (IPF). Among 1,358 patients, IPF (n=568) showed higher CAD (9.3% vs. 4.4%) and HF (8.2% vs. 3.7%) rates than non-IPF (n=790). HF was associated with worse survival and was an independent predictor of mortality (HR 3.67, p=0.0025).
Results date posted
| 2025 | Year | 10 | Month | 15 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
A total of 1,358 patients diagnosed with interstitial lung disease were included, comprising 851 males (62%) with a mean age of 68+/-10 years. Of these, 568 patients had idiopathic pulmonary fibrosis (IPF) and 790 had non-IPF interstitial lung disease. The IPF group showed significantly higher rates of smoking history, diabetes mellitus, hypertension, and dyslipidemia compared with the non-IPF group (all p<0.05). The prevalence of coronary artery disease (CAD) and heart failure (HF) was also higher in the IPF group. Pulmonary function tests revealed significantly lower %FVC and DLCO values in the IPF group, indicating more severe restrictive impairment.
Participant flow
From 2008 to 2022, a total of 1,482 patients diagnosed with interstitial lung disease were screened. After excluding 124 patients with incomplete clinical data, 1,358 patients were included in the final analysis. The study population was divided into the idiopathic pulmonary fibrosis (IPF) group (n = 568) and the non-IPF group (n = 790). Clinical data, history of coronary artery disease (CAD) and heart failure (HF), imaging findings, and pulmonary function test results were retrospectively collected. Survival status was obtained from medical records or follow-up data.
Adverse events
This was a retrospective observational study without any pharmacological or interventional procedures. Therefore, no adverse events related to the study were observed.
Outcome measures
The primary outcome was all-cause mortality. Survival time was calculated from the date of diagnosis to death or the last follow-up. Secondary outcomes included the prevalence of coronary artery disease (CAD) and heart failure (HF) in patients with idiopathic pulmonary fibrosis (IPF) and non-IPF interstitial lung disease, and the prognostic impact of these comorbidities was assessed using the Cox proportional hazards model.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 11 | Month | 10 | Day |
Date of IRB
| 2018 | Year | 12 | Month | 14 | Day |
Anticipated trial start date
| 2018 | Year | 12 | Month | 14 | Day |
Last follow-up date
| 2021 | Year | 01 | Month | 24 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Retrospective observational study
Management information
Registered date
| 2018 | Year | 11 | Month | 10 | Day |
Last modified on
| 2025 | Year | 10 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039742
