UMIN-CTR Clinical Trial

Basic information
Public title	The role of contractile reserve by stress test echocardiography for predicting cardiac resynchronization therapy (CRT) responder : systematic review and meta-analysis
Acronym	The role of contractile reserve by stress test echocardiography for predicting cardiac resynchronization therapy (CRT) responder : systematic review and meta-analysis
Scientific Title	The role of contractile reserve by stress test echocardiography for predicting cardiac resynchronization therapy (CRT) responder : systematic review and meta-analysis
Scientific Title:Acronym	The role of contractile reserve by stress test echocardiography for predicting cardiac resynchronization therapy (CRT) responder : systematic review and meta-analysis
Region	Asia(except Japan)

Condition
Condition	Heart failure
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We perform a systematic review and meta-analysis of published data to assess the relationship between contractile reserve (CR) and cardiac resynchronization therapy (CRT)-response.
Basic objectives2	Others
Basic objectives -Others	relationship to predict outcome
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	cardiac resynchronization therapy (CRT)-response
Key secondary outcomes

Base
Study type	Others,meta-analysis etc

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	18 years-old <=
Age-upper limit	90 years-old >=
Gender	Male and Female
Key inclusion criteria	1. human studies with an adult sample indicated for CRT insertion according to heart failure guideline criteria. 2. CRT dan Stress Echocardiography were done in the sampe patient population. 3. availability of contractile reserve (CR) parameter data before and after CRT. 4. clear definition of response to CRT. 5. followed up for at least 6 months post CRT insertion.
Key exclusion criteria	1. focus on specific populations (CRT super-responders, post ICD insertion population, and patients with aortic stenosis or septal flash). 2. case report studies, case series, reviews, editorials, or conference papers. 3. missing required data.
Target sample size

Research contact person
Name of lead principal investigator	1st name Ivana Middle name Purnama Last name Dewi
Organization	Faculty of Medicine, Universitas Airlangga, Surabaya, Indonesia
Division name	Department of Cardiology and Vascular Medicine
Zip code	60131
Address	Jl. Mayjen Prof. Dr. Moestopo 47
TEL	6281328098200
Email	916ivana@gmail.com

Public contact
Name of contact person	1st name Eka Middle name Prasetya Budi Last name Mulia
Organization	Faculty of Medicine, Universitas Airlangga, Surabaya, Indonesia
Division name	Department of Cardiology and Vascular Medicine
Zip code	60131
Address	Jl. Mayjen Prof. Dr. Moestopo 47
TEL	628562765365
Homepage URL	https://www.researchgate.net/profile/Eka_Mulia
Email	eka.prasetya.budi-2017@fk.unair.ac.id

Sponsor
Institute	Faculty of Medicine, Universitas Airlangga, Surabaya, Indonesia
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Government offices of other countries
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Komite Etik Penelitian Kesehatan RSUD Dr Soetomo, Surabaya, Indonesia
Address	Jalan Mayjen. Prof. Dr. Moestopo No. 6-8, Surabaya, Jawa Timur 60286
Tel	0315501011
Email	kontak@rsudrsoetomo.jatimprov.go.id

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	Faculty of Medicine, Universitas Airlangga, Surabaya, Indonesia

Other administrative information
Date of disclosure of the study information	2020 Year 08 Month 16 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications	https://doi.org/10.3889/oamjms.2021.5725
Number of participants that the trial has enrolled	1399
Results	We identified 17 studies involving 1399 patients. Presence of CR was associated with a higher chance of CRT response (OR 7.68) using a random-effects model.
Results date posted	2020 Year 10 Month 10 Day
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	2020 Year 06 Month 01 Day
Date of IRB	2020 Year 06 Month 07 Day
Anticipated trial start date	2020 Year 06 Month 08 Day
Last follow-up date	2020 Year 08 Month 16 Day
Date of closure to data entry
Date trial data considered complete	2020 Year 09 Month 10 Day
Date analysis concluded

Other

Other related information

We perform a systematic review and meta-analysis of published data to assess the relationship between contractile reserve (CR) and CRT response. We conduct a systematic search from major medical databases (PubMed, MEDLINE, Clinical Key, Cochrane Library, EMBASE). We search all clinical trials published up to June 2020, written in English, fulltext availability, and human subject. We used Newcastle Ottawa Scale (NOS) to measure the quality of evidence. We employed the Mantel Haenszel random effects meta-analysis of using RevMan 5.3

Management information
Registered date	2020 Year 08 Month 16 Day
Last modified on	2021 Year 07 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047298