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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Enrolling by invitation |
Unique ID issued by UMIN | UMIN000040648 |
Receipt No. | R000042909 |
Scientific Title | Clinical Effectiveness of Screening Sheet to Standardize Cardiac Resynchronization Therapy in Heart Failure Patients |
Date of disclosure of the study information | 2020/06/05 |
Last modified on | 2020/06/04 |
Basic information | ||
Public title | Clinical Effectiveness of Screening Sheet to Standardize Cardiac Resynchronization Therapy in Heart Failure Patients | |
Acronym | Clinical Effectiveness of Screening Sheet to Standardize Cardiac Resynchronization Therapy in Heart Failure Patients | |
Scientific Title | Clinical Effectiveness of Screening Sheet to Standardize Cardiac Resynchronization Therapy in Heart Failure Patients | |
Scientific Title:Acronym | Clinical Effectiveness of Screening Sheet to Standardize Cardiac Resynchronization Therapy in Heart Failure Patients | |
Region |
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Condition | ||
Condition | Heart Failure Patients | |
Classification by specialty |
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Classification by malignancy | Others | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | The study considers CRT treatment as one of the standard treatments for heart failure treatment, and what standard heart failure treatments are available for heart failure patients with systolic dysfunction, including those in NYHA second-degree outpatient visits. The purpose of this study was to create a flow sheet and screen for whether or not heart failure patients with symptoms of NYHA of 2 degrees or more can confirm the rate of intraventricular conduction disorder and CRT treatment can be used as a standardized heart failure treatment . |
Basic objectives2 | Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | Others |
Trial characteristics_2 | Others |
Developmental phase | Not applicable |
Assessment | |
Primary outcomes | We consider CRT treatment as one of the treatments that should be established as a standard treatment for heart failure treatment, and what kind of standard heart failure treatment is given to patients with heart failure who have systolic dysfunction before CRT treatment. |
Key secondary outcomes | We check the rate at which heart failure patients with systolic failure have intraventricular conduction disturbances, we use a flow sheet to screen whether CRT treatment can be used as a standardized heart failure treatment. |
Base | |
Study type | Observational |
Study design | |
Basic design | |
Randomization | |
Randomization unit | |
Blinding | |
Control | |
Stratification | |
Dynamic allocation | |
Institution consideration | |
Blocking | |
Concealment |
Intervention | |
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Purpose of intervention | |
Type of intervention | |
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Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | The subjects are those who have undergone CRT and those who are considering CRT treatment. | |||
Key exclusion criteria | None. | |||
Target sample size | 100 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | St. Marianna university | ||||||
Division name | Division of Cardiology | ||||||
Zip code | 216-8511 | ||||||
Address | 2-16-1, Sugao, Miyamae-Ku, Kawasaki city, Kanagawa | ||||||
TEL | 044-977-8111 | ||||||
takano.makoto@marianna-u.ac.jp |
Public contact | |||||||
Name of contact person |
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Organization | St. Marianna university | ||||||
Division name | Division of Cardiology | ||||||
Zip code | 216-8511 | ||||||
Address | 2-16-1, Sugao, Miyamae-Ku, Kawasaki city, Kanagawa | ||||||
TEL | 044-977-8111 | ||||||
Homepage URL | |||||||
takano.makoto@marianna-u.ac.jp |
Sponsor | |
Institute | St. Marianna university |
Institute | |
Department |
Funding Source | |
Organization | Medtronic |
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 | St. Marianna university |
Address | 2-16-1, Sugao, Miyamae-Ku, Kawasaki city, Kanagawa |
Tel | 044-977-8111 |
takano.makoto@marianna-u.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 |
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Date of disclosure of the study information |
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Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
Result | |
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 |
Progress | |||||||
Recruitment status | Enrolling by invitation | ||||||
Date of protocol fixation |
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Date of IRB |
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Anticipated trial start date |
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Other | |
Other related information | In this study, we consider ventricular resynchronization therapy (CRT therapy) as one of the treatments that should be established as the standard treatment for heart failure treatment, and how to treat heart failure patients with systolic insufficiency, including patients undergoing NYHA 2 outpatient visit. Standard heart failure treatment is performed, and heart failure patients with NYHA2 or higher confirm the rate of intraventricular conduction disorder and prepare a flow sheet to screen whether CRT treatment can be used as a standardized heart failure treatment and screening. |
Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042909 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |