UMIN-CTR Clinical Trial

Basic information
Public title	Effect of preoperative pulmonary hypertension on perioperative mortality among mitral stenosis patients undergoing mitral valve replacement
Acronym	Effect of preoperative pulmonary hypertension on perioperative mortality among mitral stenosis patients undergoing mitral valve replacement
Scientific Title	Effect of preoperative pulmonary hypertension on perioperative mortality among mitral stenosis patients undergoing mitral valve replacement
Scientific Title:Acronym	Effect of preoperative pulmonary hypertension on perioperative mortality among mitral stenosis patients undergoing mitral valve replacement
Region	Japan

Condition
Condition	mitral stenosis
Classification by specialty	Anesthesiology Cardiovascular surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The previous studies reported that PH had a negative effect on mortality in patients with mitral regurgitation, although not well known with mitral stenosis. The aim of our study is to clarify the impact of preoperative PH on outcome of patients with MS undergoing mitral valve replacement.
Basic objectives2	Others
Basic objectives -Others	This is a retrospective observational single-center study. Patients data will be collected from medical and anesthetic record. From January 2006 to March 2018, patients diagnosed as severe mitral stenosis and underwent mitral valve replacement at Jichi Medical University Hospital will be enrolled. Patients will be divided into two groups, PH group and non-PH group by the preoperative ratio of systolic pulmonary pressure and systolic systemic pressure as cut off value of 0.3. We compare primary endpoint between the two groups.
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Operative mortality(death within 30 days after operation or in-hospital death.) Long term mortality(period between operation and death)
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	40 years-old <=
Age-upper limit	90 years-old >=
Gender	Male and Female
Key inclusion criteria	patients with severe mitral stenosis (area of mitral valve <=1.0 cm2) who underwent mitral valve replacement
Key exclusion criteria	patients with mild or moderate mitral stenosis (area of mitral valve>1.0 cm2) patients who underwent previous mitral valve replacement urgent surgery patients without cardiac catheterization report recorded
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Middle name Last name Kenzaburou Sugimoto
Organization	Jichi Medical University
Division name	Department of Anesthesiology and Critical Care Medicine
Zip code
Address	3311-1, Yakushiji, Shimotsuke-City, Tochigi 329-0498, Japan
TEL	0285-44-2111
Email	r0923ks@jichi.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Kenzaburou Sugimoto
Organization	Jichi Medical University
Division name	Department of Anesthesiology and Critical Care Medicine
Zip code
Address	3311-1, Yakushiji, Shimotsuke-City, Tochigi 329-0498, Japan
TEL	0285-44-2111
Homepage URL
Email	r0923ks@jichi.ac.jp

Sponsor
Institute	Jichi Medical University
Institute
Department

Funding Source
Organization	Jichi Medical University
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
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	2018 Year 11 Month 13 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	69
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	2018 Year 11 Month 13 Day
Date of IRB	2018 Year 11 Month 13 Day
Anticipated trial start date	2018 Year 11 Month 13 Day
Last follow-up date	2019 Year 03 Month 31 Day
Date of closure to data entry	2019 Year 03 Month 31 Day
Date trial data considered complete
Date analysis concluded	2019 Year 04 Month 30 Day

Other
Other related information	no data

Management information
Registered date	2018 Year 11 Month 13 Day
Last modified on	2020 Year 09 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039757