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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000039250
Receipt No. R000044743
Scientific Title Poor Increase in Pulse Pressure during Cardiopulmonary Exercise Testing Predicts Prognosis in Patients with Heart Failure with Reduced Ejection Fraction
Date of disclosure of the study information 2020/01/24
Last modified on 2020/01/24

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Basic information
Public title Poor Increase in Pulse Pressure during Cardiopulmonary Exercise Testing Predicts Prognosis in Patients with Heart Failure with Reduced Ejection Fraction
Acronym Relationship between poor pulse pressure increase during exercise and prognosis in HFrEF patients
Scientific Title Poor Increase in Pulse Pressure during Cardiopulmonary Exercise Testing Predicts Prognosis in Patients with Heart Failure with Reduced Ejection Fraction
Scientific Title:Acronym Relationship between poor pulse pressure increase during exercise and prognosis in HFrEF patients
Region
Japan

Condition
Condition Patients with HFrEF
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The increase in stroke volume during inotropic stimulation in patients with heart failure with reduced ejection fraction (HFrEF) is called the "pump function reserve." Few studies have reported on the relationship between pump function reserve and heart failure prognosis. In patients with HFrEF who have pump function reserve, stroke volume would increase during exercise. In other words, the pulse pressure change during cardiopulmonary exercise testing (CPX) would be closely related to the prognosis of patients with HFrEF. We hypothesized that pulse pressure change can predict disease severity and prognosis in patients with HFrEF.
Basic objectives2 Others
Basic objectives -Others The increase in stroke volume during inotropic stimulation in patients with heart failure with reduced ejection fraction (HFrEF) is called the "pump function reserve." Few studies have reported on the relationship between pump function reserve and heart failure prognosis. In patients with HFrEF who have pump function reserve, stroke volume would increase during exercise. In other words, the pulse pressure change during cardiopulmonary exercise testing (CPX) would be closely related to the prognosis of patients with HFrEF. We hypothesized that pulse pressure change can predict disease severity and prognosis in patients with HFrEF.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes A total of 224 patients with HFrEF who underwent symptom-limited maximal CPX between 2012 and 2016 were enrolled.The endpoint was cardiovascular death. Cardiovascular death was defined as any fatal event related to coronary heart disease, cerebrovascular disease, and other heart or vascular diseases, specifically fatal myocardial infarction, acute coronary syndrome, stroke, transient ischemic attack, heart failure, and arrhythmia.The time interval from the date of CPX to cardiovascular death was defined as the duration of follow-up. Endpoints were censored in October 2018.
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Data of patients who underwent symptom-limited maximal CPX between 2012 and 2016 were analyzed. The inclusion criteria were previous or present heart failure symptoms (New York Heart Association (NYHA) functional classes II-III, American College of Cardiology/American Heart Association (ACC/AHA) classification stage C), previous documentation of left ventricular systolic dysfunction (left ventricular EF (LVEF) <40%), stable clinical condition with unchanged medications for at least 3 months, ability to perform CPX, and no major cardiovascular treatments or interventions scheduled.
Key exclusion criteria The exclusion criteria included a history of pulmonary embolism, moderate-to-severe aortic or mitral stenosis, pericardial disease, severe obstructive lung disease, exercise-induced angina and significant electrocardiographic alterations, or the presence of any clinical comorbidity that could interfere with exercising. Based on these criteria, 224 patients with HFrEF were enrolled.
Target sample size 224

Research contact person
Name of lead principal investigator
1st name Taisuke
Middle name
Last name Nakade
Organization Gunma Prefectural Cardiovascular Center
Division name Department of Cardiology
Zip code 371-0004
Address 3-12 Kameizumimachi, Maebashi, Gunma, Japan
TEL 027-269-7455
Email t.nakade.gcvc@gmail.com

Public contact
Name of contact person
1st name Taisuke
Middle name
Last name Nakade
Organization Gunma Prefectural Cardiovascular Center
Division name Department of Cardiology
Zip code 371-0004
Address 3-12 Kameizumimachi, Maebashi, Gunma, Japan
TEL 027-269-7455
Homepage URL
Email t.nakade.gcvc@gmail.com

Sponsor
Institute Gunma Prefectural Cardiovascular Center
Institute
Department

Funding Source
Organization Gunma Prefectural Cardiovascular Center
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Gunma Prefectural Cardiovascular Center
Address 3-12 Kameizumimachi, Maebashi, Gunma, Japan
Tel 027-269-7455
Email shinzouse@pref.gunma.lg.jp

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
2020 Year 01 Month 24 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled 224
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

Progress
Recruitment status Completed
Date of protocol fixation
2012 Year 04 Month 01 Day
Date of IRB
2019 Year 10 Month 31 Day
Anticipated trial start date
2012 Year 04 Month 01 Day
Last follow-up date
2020 Year 10 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Last follow up date is scheduled at the date of this study report.

Management information
Registered date
2020 Year 01 Month 24 Day
Last modified on
2020 Year 01 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044743

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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