Unique ID issued by UMIN | UMIN000040013 |
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Receipt number | R000045620 |
Scientific Title | A pilot study to evaluate the efficacy and safety of deprescribing antihypertensive drugs for prevention of cardiovascular disease in patients with advanced solid cancer. |
Date of disclosure of the study information | 2020/08/01 |
Last modified on | 2023/04/03 10:32:41 |
A pilot study to evaluate the efficacy and safety of deprescribing antihypertensive drugs for prevention of cardiovascular disease in patients with advanced solid cancer.
A pilot study to evaluate the efficacy and safety of deprescribing antihypertensive drugs for prevention of cardiovascular disease in patients with advanced solid cancer.
A pilot study to evaluate the efficacy and safety of deprescribing antihypertensive drugs for prevention of cardiovascular disease in patients with advanced solid cancer.
A pilot study to evaluate the efficacy and safety of deprescribing antihypertensive drugs for prevention of cardiovascular disease in patients with advanced solid cancer.
Japan |
advanced solid cancer, hypertension
Medicine in general | Hematology and clinical oncology |
Malignancy
NO
To evaluate the efficacy and safety of deprescribing antihypertensive drugs for prevention of cardiovascular disease in patients with advanced and life-limiting solid cancer.
Efficacy
The rate of deprescribing completion of one or more antihypertensive drugs at 8 weeks
・The rate of deprescribing completion of one or more antihypertensive drugs at 24 weeks
・The rate of deprescribing or reducing completion of one or more antihypertensive drugs at 8 and 24 weeks
・The rate of deprescribing completion of all antihypertensive drugs at 8 and 24 weeks
・Overall Survival
・Event Free Survival
・Blood pressure
・Incidence of Grade 3 or higher hypertension at 8 and 24 weeks
・Incidence of symptoms associated with increased blood pressure (shortness of breath (dyspnea), dizziness, headache, palpitations) at 8 and 24 weeks
・Incidence of cardiovascular disease
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
・Discontinue (or discontinue after the reduction of dosage of) antihypertensive drugs for primary prevention of cardiovascular disease at the time of visit.
・If the patients take high dose of antihypertensive drugs, it will be reduced half. If the patients take two or more antihypertensive drugs, one of them will be discontinued or reduced one-by-one.
・The priority for discontinuation or reducion of the type of antihypertensive drug will be determined based on the latest guidelines for the treatment of hypertension.
・Target blood pressure after the discontinuation should not exceed 160/100 mmHg (comparable to Grade 3 of hypertension (CTCAE v.5)).
・The recent treatment will be restarted in consideration of the pathophysiological change after the discontinuation.
・In other cases, the subjects receive the medical treatment in accordance with the latest guidelines for the treatment of hypertension.
20 | years-old | <= |
Not applicable |
Male and Female
(1) Patients who are diagnosed as the solid cancer by cytology or histology and are consulting the department of Medical Oncology at Kobe University Hospital
(2) Patients who are 20 years old or older at the time of obtaining consent
(3) Patients with ECOG-PS of 0-2
(4) Patients who are indicated by researcher (physician) that he or she "will not be surprised if the patient died within one year"
(5) Patients expected to survive for 3 months or more
(6) Patients who fall under any of the following:
6-1) Planning to introduce the standard cancer drug
6-2) Ongoing standard cancer drug therapy
6-3) Completed standard cancer drug therapy
(7) The standard cancer drug therapy which is not intended to be curative is scheduled or ongoing
(8) Patients who have taken one or more antihypertensive drugs for at least one month for essential hypertension
(9) Patients with good blood pressure control: Home blood pressure in the last week does not exceed 140/90 mmHg for more than 5 days
(10) Patients who have given their informed consent to participate in this study
(1) Patients with a history of cardiovascular disease
(2) Patients with secondary hypertension
(3) Patients who fall under any of the following:
3-1) Duration of treatment with anti-VEGF antibody or within 28 days after the treatment
3-2) Duration of treatment with multi kinase inhibitor or within 14 days after the treatment
3-3) Duration of treatment with BRAF inhibitor (with or without MEK inhibitor) or within 14 days after the treatment
(4) Patients judged inappropriateness by the researcher
18
1st name | Ikuko |
Middle name | |
Last name | Yano |
Kobe University
Department of Pharmacy
650-0017
7-5-2 Kusunoki-cho, Chuo-ku, Kobe, Japan
078-382-5111
iyano@med.kobe-u.ac.jp
1st name | Masaaki |
Middle name | |
Last name | Tanda |
Kobe University
Department of Pharmacy
650-0017
7-5-2 Kusunoki-cho, Chuo-ku, Kobe, Japan
078-382-5111
mtanda-kobe@umin.ac.jp
Kobe University
Kobe University
Other
Kobe University
7-5-2 Kusunoki-cho, Chuo-ku, Kobe, Japan
078-382-5111
kainyu@med.kobe-u.ac.jp
NO
2020 | Year | 08 | Month | 01 | Day |
Unpublished
18
No longer recruiting
2020 | Year | 03 | Month | 01 | Day |
2020 | Year | 04 | Month | 28 | Day |
2020 | Year | 08 | Month | 01 | Day |
2025 | Year | 03 | Month | 31 | Day |
2020 | Year | 03 | Month | 31 | Day |
2023 | Year | 04 | Month | 03 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045620
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