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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000040013
Receipt No. 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 2020/08/05

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Basic information
Public 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.
Acronym A pilot study to evaluate the efficacy and safety of deprescribing antihypertensive drugs for prevention of cardiovascular disease in patients with advanced solid cancer.
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.
Scientific Title:Acronym A pilot study to evaluate the efficacy and safety of deprescribing antihypertensive drugs for prevention of cardiovascular disease in patients with advanced solid cancer.
Region
Japan

Condition
Condition advanced solid cancer, hypertension
Classification by specialty
Medicine in general Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy and safety of deprescribing antihypertensive drugs for prevention of cardiovascular disease in patients with advanced and life-limiting solid cancer.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The rate of deprescribing completion of one or more antihypertensive drugs at 8 weeks
Key secondary outcomes ・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

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 ・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.
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

Not applicable
Gender Male and Female
Key inclusion criteria (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
Key exclusion criteria (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
(4) Patients judged inappropriateness by the researcher
Target sample size 18

Research contact person
Name of lead principal investigator
1st name Ikuko
Middle name
Last name Yano
Organization Kobe University
Division name Department of Pharmacy
Zip code 650-0017
Address 7-5-2 Kusunoki-cho, Chuo-ku, Kobe, Japan
TEL 078-382-5111
Email iyano@med.kobe-u.ac.jp

Public contact
Name of contact person
1st name Masaaki
Middle name
Last name Tanda
Organization Kobe University
Division name Department of Pharmacy
Zip code 650-0017
Address 7-5-2 Kusunoki-cho, Chuo-ku, Kobe, Japan
TEL 078-382-5111
Homepage URL
Email mtanda-kobe@umin.ac.jp

Sponsor
Institute Kobe University
Institute
Department

Funding Source
Organization Kobe University
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 Kobe University
Address 7-5-2 Kusunoki-cho, Chuo-ku, Kobe, Japan
Tel 078-382-5111
Email kainyu@med.kobe-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

Other administrative information
Date of disclosure of the study information
2020 Year 08 Month 01 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
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 Open public recruiting
Date of protocol fixation
2020 Year 03 Month 01 Day
Date of IRB
2020 Year 04 Month 28 Day
Anticipated trial start date
2020 Year 08 Month 01 Day
Last follow-up date
2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 03 Month 31 Day
Last modified on
2020 Year 08 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045620

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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