UMIN-CTR Clinical Trial

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
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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