UMIN-CTR Clinical Trial

Basic information
Public title	Prevention of Postoperative Atrial Fibrillation after Heart Valve Surgery by L-Carnitine: Study Protocol for An Observational Intervention Study
Acronym	Prevention of Postoperative Atrial Fibrillation by L-Carnitine
Scientific Title	Prevention of Postoperative Atrial Fibrillation after Heart Valve Surgery by L-Carnitine: Study Protocol for An Observational Intervention Study
Scientific Title:Acronym	Prevention of Postoperative Atrial Fibrillation by L-Carnitine
Region	Japan

Condition
Condition	Heart valve diseases
Classification by specialty	Surgery in general Vascular surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To assess the safety and effectiveness of L-carnitine as a perioperative medication for postoperative atrial fibrillation
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The incidence of atrial fibrillation within seven days after surgery
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
Stratification	NO
Dynamic allocation	NO
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	The total intervention period will be nine days. L-carnitine (L-Cartin FF oral solution 10%, Otsuka Pharmaceutical Co., Ltd., Tokyo) (3 gm/day) will be administered daily to the patients in three oral doses (1 gm, 1 gm, and 1 gm) for two days just before surgery. The same doses will be given to the patients from postoperative days 1 to 7.
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	20 years-old <=
Age-upper limit	90 years-old >
Gender	Male and Female
Key inclusion criteria	1. They are patients with a diagnosis of heart valve disease necessitating elective surgery under cardiac arrest through median sternotomy with or without coronary artery bypass grafting. 2. They are between 20 and 90 years of age. 3. They are competent and able to give informed consent.
Key exclusion criteria	1. They have a history of atrial fibrillation or flutter before surgery. 2. They have renal failure (serum creatinine > 2.0 mg/dl). 3. They are pregnant. 4. They are lactating.
Target sample size	20

Research contact person
Last name of lead principal investigator	1st name Yoshiro Middle name Last name Matsui
Organization	Hokkaido University Graduate School of Medicine
Division name	Department of Cardiovascular and Thoracic Surgery
Zip code	060-8638
Address	Kita 15, Nishi 7, Kitaku Sapporo, 060-8638, Japan
TEL	011-706-6042
Email	ymatsui@med.hokudai.ac.jp

Public contact
1st name of contact person	1st name Yasushige Middle name Last name Shingu
Organization	Hokkaido University Graduate School of Medicine
Division name	Department of Cardiovascular and Thoracic Surgery
Zip code	060-8638
Address	Kita 15, Nishi 7, Kitaku Sapporo, 060-8638
TEL	011-706-6042
Homepage URL
Email	shingu@huhp.hokudai.ac.jp

Sponsor
Institute	Hokkaido University Hospital; Department of Cardiovascular and Thoracic Surgery
Institute
Department

Funding Source
Organization	Hokkaido University Hospital
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	Japan

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

IRB Contact (For public release)
Organization	Hokkaido University
Address	Kita-14 Nishi-5, Kita-Ku, Sapporo, Japan
Tel	011-706-7636
Email	crjimu@huhp.hokudai.ac.jp

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	2017 Year 01 Month 30 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled	16
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	2017 Year 01 Month 19 Day
Date of IRB	2017 Year 05 Month 01 Day
Anticipated trial start date	2017 Year 07 Month 01 Day
Last follow-up date	2019 Year 03 Month 22 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2017 Year 01 Month 19 Day
Last modified on	2019 Year 03 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029371