UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039250 |
|---|---|
| Receipt number | 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 13:54:00 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
t.nakade.gcvc@gmail.com
Sponsor or person
Institute
Gunma Prefectural Cardiovascular Center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044743
