UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Cardiovascular function in children with heart failure with preserved ejection fraction
Title of the study (Brief title)	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	Satoshi Masutani
Organization	Saitama Medical Center, Saitama Medical School
Division name	Pediatrics
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	Satoshi Masutani
Organization	Saitama Medical Center, Saitama Medical School
Division name	Pediatrics
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)

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

Progress
Recruitment status	Main results already published
Date of protocol fixation	2013 Year 04 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000012658