臨床研究等提出・公開システム

Exploratory analysis of the effects of Advanced Care planning guided by the prediction program of heart failure prognosis on QUAality of life In patieNTs with heart failure (ACQUAINT-trial)

ACQUAINT-trial (ACQUAINT-trial)

Izumi Chisato

National cerebral and cardiovascular center

6-1 Kishibe-Shinmachi, Suita, Osaka

acquaint-trial@ncvc.go.jp

Kitai Takeshi

National Cerebral and Cardiovascular Center

6-1 Kishibe-Shinmachi, Suita, Osaka

+81-6-6170-1070

acquaint-trial@ncvc.go.jp

Recruiting

Oct. 09, 2020

Interventional

randomized controlled trial

single blind

no treatment control/standard of care control

parallel assignment

supportive care

1) Age > 20 y.o. at the enrollment
2) Hospitalized patients diagnosed as heart failure
3) NYHA>3 HF symptom
4) Patients who are able to provide written consent
5) Patient who fullfill the following criteria, either a) or b)
a) Patients presenting who had heart failure hopitalization history at least two times before the enrollment
b) Patients presenting with BNP not lower than 500pg/ml or NT-proBNP not lower than 2000 pg/ml within 6 months from the corresponding hospial admission

1) Patients waiting for heart transplantation or being considered eligibility for heart transplantation
2) Patients waiting for cardiac surgery
3) Patients who are unable to understand the details of the test
4) Patients who are unable to express his/her intestion such as under the influence of sedative medicine
5) Patients who are participating the other invesive clinical trials
6) Patients who have already received full advanced care planning
7) Patients who are not willing to receive advanced care planning
8) Patiens who affected with severe disease (one year less to live)
9) Patients with severe phycological illness
10) Patiens with worsening heart failure even after the hospital admission
11) Patients considered ineligible to participate in this study by principal or sub investigator

Both

Heart failure

Provide the information of clinical prognosis

Heart failure

Single-blind

D006333

D016037

Medical staff: the frequency of starting advanced care planning from the enrollment to the discharge date
Patients: differences in SDM-Q-9 score from the enrollment to the discharge date

1. Differences in term between the enrollment date and ACP starting date (comparison intervention group with control group)
2. the frequency of starting advanced care planning (12 week)
3. the frequency of starting advanced care planning (24 week)
4. Questionnaire score (comparison intervention group with control group)(during the hospitalization)
5. Questionnaire score (comparison intervention group with control group)(12 week)
6. Questionnaire score (comparison intervention group with control group)(24 week)
7. Questionnaire score (comaprison patients received ACP with those who have not received ACP)
8. Composite end-point: cardiovascular death or hospitalization (final visit)
9. Composite end-point: cardiovascular death or heart failure hospitalization (final visit)
10. Frequency of occurences of cardiovascular death
11. Frequency of hospitalization due to cardiovascular disease
12. Frequency of hospitalization due to heart failure
13. Frequency of death from all causes
14. Frequency of hospitalization from any reason
15. Additinal medication for heart failure treatment (12w, 24 w and at the end of the study)
16. Association of the predicted score by the heart failure calculator with the clinical outcomes.
17. Questionnaire score for family (comparison intervention group with control group)
18. Questionnaire score for family (comaprison patients received ACP with those who have not received ACP)

+81-6-6170-1070

Aug. 20, 2020

No

none