Unique ID issued by UMIN | UMIN000023423 |
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Receipt number | R000026985 |
Scientific Title | Effects of Eicosapentaenoil acid rich Fish Oil on Exercise economy in patients with Cardiovascular Diseases |
Date of disclosure of the study information | 2016/08/01 |
Last modified on | 2019/03/19 17:33:55 |
Effects of Eicosapentaenoil acid rich Fish Oil on Exercise economy in patients with Cardiovascular Diseases
Effects of Eicosapentaenoil acid rich Fish Oil on Exercise economy in patients with Cardiovascular Diseases
Effects of Eicosapentaenoil acid rich Fish Oil on Exercise economy in patients with Cardiovascular Diseases
Effects of Eicosapentaenoil acid rich Fish Oil on Exercise economy in patients with Cardiovascular Diseases
Japan |
Heart disorder
Cardiology |
Others
NO
In chronic heart failure patients and post PCI with acute coronary syndrome patients, we do a difference from the baseline of the oxygen intake of CPX three months later with an index after combined treatment initiation by exercise efficiency about the treatment that we combined placebo of experimental diet supplement A with for treatment and the basics treatment that we combined experimental diet supplement A(EPA) administration with for treatment (basic treatment) conventionally and test an advantage of the EPA combined treatment.
The safety weighs examinations for peripheral blood against the symptom of the patients for an index primarily.
Safety,Efficacy
Confirmatory
Pragmatic
Not applicable
It is the same extreme(60% of the load at the maximum oxygen intake at CPX before beginning of dosage) oxygen intake at Cardiopulmonary Exercise Test(CPX) as of 12 weeks and a difference from the baseline after beginning of dosage
An effective evaluation:It is the echocardiography evaluation as of at 12 weeks and 24 weeks, a fluidity of blood evaluation, drawing blood (CBC, lipid-based system, hsCRP, EPA/AA), quality of life questionary survey, an oxidative stress degree by the d-ROMs test after beginning of dosage.
It is the same extreme oxygen intake at CPX as of 24 weeks and a difference from the baseline after beginning of dosage
Safety assessment:Adverse event (bleeding tendency in particular, examination for peripheral blood (oligochromemia, leukopenia, thrombocytopenia, incidence) of high TG blood disease)
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
YES
YES
Institution is not considered as adjustment factor.
YES
Central registration
2
Treatment
Food |
EPA 900mg/day
placebo
41 | years-old | < |
81 | years-old | > |
Male and Female
1)Less than LVEF40% or BNP 80pg/ml more
2)chronic heart failure patients or poat PCI with acute coronary syndrome patients
1)Recent cerebrovascular event within 3 months
2)Acute heart failure
3)Less than eGFR30
4)NOAC or Warfarin
40
1st name | Takanori |
Middle name | |
Last name | Yasu |
Dokkyo Medical University Nikko Medical Center
Department of Cardiovascular medicine and Nephrology
321-2593
632 Takatoku, Nikko City, Tochigi
0288-76-1515
kawaatsu@dokkyomed.ac.jp
1st name | Akiko |
Middle name | |
Last name | Niijima |
Dokkyo Medical University Nikko Medical Center
Clinical Research Support Center
321-2593
632 Takatoku, Nikko City, Tochigi
0288-76-1515
aniijima@dokkyomed.ac.jp
Dokkyo Medical University Nikko Medical Center
Nippon Suisan Kaisha,Ltd
Profit organization
Dokkyo Medical University Nikko Medical Center Clinical Research Support Center
632 Takatoku, Nikko City, Tochigi
0288-76-1515
amiijima@dokkyomed.ac.jp
NO
2016 | Year | 08 | Month | 01 | Day |
Unpublished
40
Completed
2016 | Year | 06 | Month | 20 | Day |
2016 | Year | 05 | Month | 13 | Day |
2016 | Year | 07 | Month | 13 | Day |
2019 | Year | 01 | Month | 10 | Day |
2016 | Year | 08 | Month | 01 | Day |
2019 | Year | 03 | Month | 19 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026985
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