Hypertension,EssentialNCT05972785
Long-term Use of CCB and Breast Cancer Risk
An observational study of Hypertension,Essential and Breast Cancer, run by Curtin University at 1 site in Australia.
Trial summary
The goal of this retrospective observational study is to examine whether long-term calcium channel blocker (CCB) use is associated with the development of breast cancer amongst women enrolled in three longitudinal cohort studies in Australia and the Netherlands . Read more about this study
- Who is it for?
- Ages 45 years and older, women only
- Conditions the study is for
- Hypertension,Essential, Breast Cancer
- What is being tested?
- Calcium channel blocker, Beta blocker and Diuretic
- How many people
- 68,500 participants
- Where
- 1 siteAustralia
- Study dates
- 1 Jul 2022to Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- Women only
- Adult, Older adult
Study population: The study will include eligible women enrolled in three longitudinal cohorts: ALSWH, 45 and Up Study and the Rotterdam study.
Who may be able to join
- Alive and still enrolled in the longitudinal cohort at the study entry (2004 to 2009)
- Self-reported/diagnosed hypertension at study entry.
Who cannot join
- + A history of breast cancer.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Association of Long-term Use of Calcium Channel Blockers (CCB) and Risk of Breast Cancer: A Retrospective Longitudinal Observational Study
The goal of this retrospective observational study is to examine whether long-term calcium channel blocker (CCB) use is associated with the development of breast cancer amongst women enrolled in three longitudinal cohort studies in Australia and the Netherlands . The main questions it aims to answer are:
- Is long-term CCB use associated with the development of breast cancer amongst women enrolled in three longitudinal cohort studies in Australia and the Netherlands and what is the dose-response nature of this association.
- Does differences in the association between calcium channel blocker use and the development of breast cancer exist between Australian and Dutch women.
The investigators will utilise data from the Australian Longitudinal Study on Women's Health (ALSWH) , 45 and Up Study and Rotterdam study.
Read the detailed description
Aims: To examine the association between long-term calcium channel blocker (CCB) use and the development of breast cancer.
Data sources: the Australian Longitudinal Study on Women's Health , 45 and Up Study, Rotterdam study and linked administrative data.
Study cohort: Women with self-reported hypertension (HTN) without prior breast cancer.
Harmonisation: Relevant variables will be checked for harmonisation in which variables available in all three cohort will be used in the harmonised analysis. The variables will be checked on the definition, measurement and harmonisation rules. Variables that cannot be harmonised across the cohorts will be used in the cohort specific analyses.
Exposure measurement: The primary exposure is the use of CCB, which will be identified by the anatomical therapeutic chemical code (C08) in the medicine data. Exposure to CCB as well as other antihypertensive (AHT) medicines will be captured separately as the cumulative dose-duration of exposure during follow up. Participants will be stratified in four groups: women with HTN with no AHT use, women with HTN exposed to CCB only, women with HTN exposed to non-CCB and women with HTN exposed to both CCB and non-CCB.
Outcome measurement: Data on a diagnosis of invasive breast cancer will be obtained from cancer registries and hospital admission data using ICD-10 code of C50.x.
Potential confounders: age, education, marital status, socioeconomic status, body mass index, diabetes, heart disease, stroke, age when had first child, parity, history of hysterectomy or oophorectomy, use of hormonal contraception, use of hormonal replacement therapy.
Statistical analysis: The association between CCB use and breast cancer risk will be estimated by the Fine and Gray competing risk regression model in which a first diagnosis of invasive breast cancer will be treated as the principle event and death and bilateral mastectomy (without a diagnosis of breast cancer) will be competing risks. The nonlinear threshold models will be used to capture any differential effect of the cumulative dose-duration of CCB while simultaneously accounting for the cumulative dose-duration of other AHT exposure on breast cancer risk. Other confounders will be accounted for in the models using propensity scores.
Implications: Results from this study will contribute to addressing the concerns about using CCB for hypertension treatment in women, particularly in those who have high risk of breast cancer.
- Conditions
- Hypertension,Essential, Breast Cancer
- Being tested
- Calcium channel blocker, Beta blocker, Diuretic, RAS, Other AHT
- Medical subject headings
- Essential Hypertension, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calcium channel blockerDrug
Drugs with ATC code C08 will be categorised as calcium channel blockers.
Beta blockerDrug
Drugs with ATC code C07 will be categorised as beta-blockers.
DiureticDrug
Drugs with ATC code C03 will be categorised as diuretics.
RASDrug
Drugs with ATC code C09 will be categorised as RAS (agents acting on the renin angiotensin system).
Other AHTDrug
Drugs with ATC code C02 will be categorised as other antihypertensives.
None AHTDrug
None AHT
| Study group | Role | What they receive |
|---|---|---|
| No AHT | Women with HTN with no AHT use Receives: Drug: None AHT | |
| AHT but non-CCB | Women with HTN exposed to other antihypertensive medicines but not exposed to calcium channel blockers Receives: Drug: Beta blocker; Drug: Diuretic; Drug: RAS; Drug: Other AHT | |
| CCB only | Women with HTN exposed to calcium channel blockers but not exposed to other antihypertensive medicines Receives: Drug: Calcium channel blocker | |
| Both CCB and non-CCB | Women with HTN exposed to both calcium channel blockers and other antihypertensive medicines. Receives: Drug: Calcium channel blocker; Drug: Beta blocker; Drug: Diuretic; Drug: RAS; Drug: Other AHT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incident rate of invasive breast cancer
The outcome will be defined based on the ICD-10 code of C50.x (malignant neoplasm of breast).
Measured: From cohort entry until the earliest date of one of the following: a diagnosis of invasive breast cancer, bilateral mastectomy (without breast cancer) or death, assessed up to 14 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2023
- Study start1 Jul 2022
- Primary completion30 Jun 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hypertension,EssentialStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 68,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Curtin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rachael Moorin, Curtin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05972785
- Sponsor's protocol ID
- 2014896
- Status last verified
- Aug 2024
- First submitted
- 24 Jul 2023
- Last updated
- 21 Aug 2024
- Results posted
- No
- Individual data sharing
- No
Publications
Ho C, Ha NT, Youens D, Abhayaratna WP, Bulsara MK, Hughes JD, Mishra G, Pearson SA, Preen DB, Reid CM, Ruiter R, Saunders CM, Stricker BH, van Rooij FJA, Wright C, Moorin R. Association between long-term use of calcium channel blockers (CCB) and the risk of breast cancer: a retrospective longitudinal observational study protocol. BMJ Open. 2024 Mar 8;14(3):e080982. doi: 10.1136/bmjopen-2023-080982.
PubMed 38458796
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of Long-term Use of Calcium Channel Blockers (CCB) and Risk of Breast Cancer: A Retrospective Longitudinal Observational Study
- ClinicalTrials.gov ID
- NCT05972785
- Acronym / sponsor ID
- 2014896
- Conditions
- Hypertension,Essential, Breast Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 68,500 participants (estimated)
- Lead sponsor
- Curtin UniversityUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 2 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this retrospective observational study is to examine whether long-term calcium channel blocker (CCB) use is associated with the development of breast cancer amongst women enrolled in three longitudinal cohort studies in Australia and the Netherlands . The main questions it aims to answer are:
- Is long-term CCB use associated with the development of breast cancer amongst women enrolled in three longitudinal cohort studies in Australia and the Netherlands and what is the dose-response nature of this association.
- Does differences in the association between calcium channel blocker use and the development of breast cancer exist between Australian and Dutch women.
The investigators will utilise data from the Australian Longitudinal Study on Women's Health (ALSWH) , 45 and Up Study and Rotterdam study.
Detailed description
Aims: To examine the association between long-term calcium channel blocker (CCB) use and the development of breast cancer.
Data sources: the Australian Longitudinal Study on Women's Health , 45 and Up Study, Rotterdam study and linked administrative data.
Study cohort: Women with self-reported hypertension (HTN) without prior breast cancer.
Harmonisation: Relevant variables will be checked for harmonisation in which variables available in all three cohort will be used in the harmonised analysis. The variables will be checked on the definition, measurement and harmonisation rules. Variables that cannot be harmonised across the cohorts will be used in the cohort specific analyses.
Exposure measurement: The primary exposure is the use of CCB, which will be identified by the anatomical therapeutic chemical code (C08) in the medicine data. Exposure to CCB as well as other antihypertensive (AHT) medicines will be captured separately as the cumulative dose-duration of exposure during follow up. Participants will be stratified in four groups: women with HTN with no AHT use, women with HTN exposed to CCB only, women with HTN exposed to non-CCB and women with HTN exposed to both CCB and non-CCB.
Outcome measurement: Data on a diagnosis of invasive breast cancer will be obtained from cancer registries and hospital admission data using ICD-10 code of C50.x.
Potential confounders: age, education, marital status, socioeconomic status, body mass index, diabetes, heart disease, stroke, age when had first child, parity, history of hysterectomy or oophorectomy, use of hormonal contraception, use of hormonal replacement therapy.
Statistical analysis: The association between CCB use and breast cancer risk will be estimated by the Fine and Gray competing risk regression model in which a first diagnosis of invasive breast cancer will be treated as the principle event and death and bilateral mastectomy (without a diagnosis of breast cancer) will be competing risks. The nonlinear threshold models will be used to capture any differential effect of the cumulative dose-duration of CCB while simultaneously accounting for the cumulative dose-duration of other AHT exposure on breast cancer risk. Other confounders will be accounted for in the models using propensity scores.
Implications: Results from this study will contribute to addressing the concerns about using CCB for hypertension treatment in women, particularly in those who have high risk of breast cancer.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| No AHT | – | Drug: None AHTWomen with HTN with no AHT use |
| AHT but non-CCB | – | Drug: Beta blocker, Drug: Diuretic, Drug: RAS, Drug: Other AHTWomen with HTN exposed to other antihypertensive medicines but not exposed to calcium channel blockers |
| CCB only | – | Drug: Calcium channel blockerWomen with HTN exposed to calcium channel blockers but not exposed to other antihypertensive medicines |
| Both CCB and non-CCB | – | Drug: Calcium channel blocker, Drug: Beta blocker, Drug: Diuretic, Drug: RAS, Drug: Other AHTWomen with HTN exposed to both calcium channel blockers and other antihypertensive medicines. |
Who may qualify
- Ages
- 45 years and older
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- The study will include eligible women enrolled in three longitudinal cohorts: ALSWH, 45 and Up Study and the Rotterdam study.
Key inclusion criteria (2 listed)
- Alive and still enrolled in the longitudinal cohort at the study entry (2004 to 2009)
- Self-reported/diagnosed hypertension at study entry.
Key exclusion criteria (1 listed)
- + A history of breast cancer.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Calcium channel blockerDrugs with ATC code C08 will be categorised as calcium channel blockers. | Drug | Both CCB and non-CCB, CCB only |
| Beta blockerDrugs with ATC code C07 will be categorised as beta-blockers. | Drug | AHT but non-CCB, Both CCB and non-CCB |
| DiureticDrugs with ATC code C03 will be categorised as diuretics. | Drug | AHT but non-CCB, Both CCB and non-CCB |
| RASDrugs with ATC code C09 will be categorised as RAS (agents acting on the renin angiotensin system). | Drug | AHT but non-CCB, Both CCB and non-CCB |
| Other AHTDrugs with ATC code C02 will be categorised as other antihypertensives. | Drug | AHT but non-CCB, Both CCB and non-CCB |
| None AHTNone AHT | Drug | No AHT |
Primary outcome
Incident rate of invasive breast cancer
Time frame: From cohort entry until the earliest date of one of the following: a diagnosis of invasive breast cancer, bilateral mastectomy (without breast cancer) or death, assessed up to 14 years.
The outcome will be defined based on the ICD-10 code of C50.x (malignant neoplasm of breast).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2024.
- Derived from this study: PubMed 38458796Ho C, Ha NT, Youens D, Abhayaratna WP, Bulsara MK, Hughes JD, Mishra G, Pearson SA, Preen DB, Reid CM, Ruiter R, Saunders CM, Stricker BH, van Rooij FJA, Wright C, Moorin R. Association between long-term use of calcium channel blockers (CCB) and the risk of breast cancer: a retrospective longitudinal observational study protocol. BMJ Open. 2024 Mar 8;14(3):e080982. doi: 10.1136/bmjopen-2023-080982.
- Individual participant dataSharing planned: No
Related trials for Hypertension,Essential
Recruiting
The Effect of Self-Acupressure on Blood Pressure, Stress, and Well-Being Levels in Individuals With Hypertension
PRIMARY HYPERTENSION
Active, not recruiting
Smartphone-Guided Paced Breathing and Aerobic Exercise for Essential Hypertension
Essential (Primary) Hypertension
Recruiting
Isometric Resistance Exercise on Accelerated Atherosclerosis in Hypertension
Atherosclerosis Cardiovascular Disease
Not yet recruitingObservational study
A Study to Evaluate the Effectiveness and Safety of S-amlodipine-based Monotherapy and Combination Therapy
Hypertension (HTN), Hypertension
Recruiting
Community Health Worker Support to Lower Blood Pressure After a Pregnancy With High Blood Pressure
Pregnancy-Associated Hypertension, Gestational Hypertension
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertension,Essential and Breast Cancer, run by Curtin University at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incident rate of invasive breast cancer (time frame: From cohort entry until the earliest date of one of the following: a diagnosis of invasive breast cancer, bilateral mastectomy (without breast cancer) or death, assessed up to 14 years.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05972785, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2024.