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UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000010821
Receipt No. R000012658
Scientific Title Cardiovascular function in children with heart failure with preserved ejection fraction
Date of disclosure of the study information 2013/05/29
Last modified on 2017/05/31

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Basic information
Public title Cardiovascular function in children with heart failure with preserved ejection fraction
Acronym Cardiovascular function in children with heart failure with preserved ejection fraction
Scientific Title Cardiovascular function in children with heart failure with preserved ejection fraction
Scientific Title:Acronym Cardiovascular function in children with heart failure with preserved ejection fraction
Region
Japan

Condition
Condition Heart failure with preserved ejection fraction in children
Control
Classification by specialty
Pediatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To assess the hypothesis that children with HFpEF may have increased ventricular and vascular stiffening with appropriate coupling, but have impaired cathecolamic reserve in ventricular and vascular coupling compared to those without HFpEF.
Basic objectives2 Others
Basic objectives -Others hemodynamics
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Preload: LV end-diastolic area
Afterload: Effective arterial elastance (Ea)
Contractility: End-systolic elastance (Ees), preload recruitable stroke work
Diastolic function: End-diastolic pressure area relationship, time constant of relaxation
Heart rate
Ventricular-vascular coupling: Ees/Ea
Dobutamine induced changes of above indices.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Diagnosis
Type of intervention
Maneuver
Interventions/Control_1 Transient inferior vena caval occlusion test
about 10 seconds
Interventions/Control_2 Small amount of dobutamine infusion test.
15 minutes
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
6 months-old <
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) Children who are indicated for cardiac catheterization.
2) Children who have heart failure symptoms despite preserved ejection fraction (EF>50%) by echocardiography
3) HFpEF is defined as having HF signs or symptoms with LV EF greater than 50%. Clinical signs and symptoms of HF with no other identifiable cause and improvement following diuresis are: dyspnea on exertion/milk feeding, bilateral edema of the lower extremities, or hepatomegaly. Lung diseases, particularly chronic forms, were carefully screened and ruled out as non-cardiac causes of symptoms by both chest radiography and medical history. Patients presenting with HF signs or symptoms that were associated with increased pulmonary blood flow or atrio-ventricular regurgitation (more than grade II by echocardiography) were excluded. Other exclusion criteria were being within two months after surgical correction of cardiovascular lesions, univentricular circulation, hypertrophic/ restrictive cardiomyopathies, and chromosomal abnormalities.
4) Control patients: ventricular septal defect or patent ductus arteriosus (pulmonary to systemic output ratio < 1.3)
5) Written informed consent is obtained from the parents of all patients
Key exclusion criteria Patients who cannot perform all scheduled evaluations because of their poor conditions.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Satoshi Masutani
Organization Saitama Medical Center, Saitama Medical School
Division name Pediatrics
Zip code
Address 1981 Kamoda, Kawagoe-shi, SAITAMA 350-8550, JAPAN
TEL 049-228-3550
Email smstn@ka2.so-net.ne.jp

Public contact
Name of contact person
1st name
Middle name
Last name Satoshi Masutani
Organization Saitama Medical Center, Saitama Medical School
Division name Pediatrics
Zip code
Address 1981 Kamoda, Kawagoe-shi, SAITAMA 350-8550, JAPAN
TEL 049-228-3550
Homepage URL
Email smstn@ka2.so-net.ne.jp

Sponsor
Institute Saitama Medical Center, Saitama Medical School
Institute
Department

Funding Source
Organization Research Grant (Ministry of Education, Culture, Sports, Science and Technology)
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2013 Year 05 Month 29 Day

Related information
URL releasing protocol
Publication of results Published

Result
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

Progress
Recruitment status Main results already published
Date of protocol fixation
2013 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2013 Year 05 Month 29 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 05 Month 28 Day
Last modified on
2017 Year 05 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012658

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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