UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000040013
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

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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
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

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 or person

Institute

Kobe University

Institute

Department

Personal name



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

18

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

No longer 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

2025 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

2023 Year 04 Month 03 Day



Link to view the page

Value
https://center6.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