UMIN-CTR Clinical Trial

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

Heart failure with preserved ejection fraction in children
Control

Classification by specialty

Pediatrics

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Interventional

Basic design

Parallel

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

No treatment

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Saitama Medical Center, Saitama Medical School

Institute

Department

Personal name

Organization

Research Grant (Ministry of Education, Culture, Sports, Science and Technology)

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2013

Year

05

Month

29

Day

URL releasing protocol

Publication of results

Published

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

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 related information

Registered date

2013

Year

05

Month

28

Day

Last modified on

2017

Year

05

Month

31

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012658