Cardiovascular DiseasesZWOT-CASENCT03428061
The ZWOlle Transmural Integrated Care for CArdiovaScular Risk Management Study
An observational study of Cardiovascular Diseases and Hypercholesterolemia, run by UMC Utrecht at 1 site in Netherlands.
Trial summary
Cardiovascular disease (CVD) contributes importantly to mortality and morbidity. Prevention of CVD by lifestyle change and medication is important and needs full attention. In the Netherlands an integrated program for cardiovascular risk management (CVRM), based on the Chronic Care Model (CCM), has been introduced in… Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Cardiovascular Diseases, Hypercholesterolemia, Hypertension
- What is being tested?
- Integrated care for cardiovascular risk management
- How many people
- 740 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Sep 2017to 31 Mar 2018
- 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 40 to 80 years
- All sexes
- Adult, Older adult
Study population: The ZWOT-CASE study population will consist of a subgroup of 370 patients from the integrated CVRM care group (intervention) and 370 patients in the usual care (control) group. Both groups consist of respectively i) 185 patients with known CVD and ii) 185 patients with a high (>10%) ten year risk of CVD morbidity and mortality based on the Dutch Guideline for CVRM.
Who may be able to join
- Patients with a history of atherosclerotic CVD defined as documented angina pectoris, myocardial infarction, chronic ischemic heart disease, coronary sclerosis, transient ischaemic attack (TIA), cerebral infarction, intermittent claudication or aneurysm of the abdominal aorta
- The CV risk of the patient is managed in primary care, not in the hospital or outpatient clinic by a medical specialist
- Age between 40 and 80 years
- Use of blood pressure lowering or lipid lowering drugs
- A 10 -years CV risk > 10%, based on the Dutch guideline for CVRM and i) either 1 strongly cardiovascular risk enhancing factor or 2 mildly cardiovascular risk enhancing factors (see table 6) or ii) > 1 CV risk factor (current smoking, SBP>140 mmHg, LDL>2.5 mmol/L, TC/HDL-ratio > 8, chronic renal impairment (age < 65 years: eGFR < 60 ml/min/1,73 m2; age ≥ 65 years: eGFR < 45 ml/min/1,73 m2, and/or (micro)albuminuria).
- A 10-year CV risk of >20% and > 1 CV risk factor (current smoking, SBP>140 mmHg, LDL>2.5 mmol/L, TC/HDL-ratio > 8, chronic renal impairment (age < 65 years: eGFR < 60 ml/min/1,73 m2; age ≥ 65 years: eGFR < 45 ml/min/1,73 m2, and/or (micro)albuminuria).
- The CV risk of the patient is managed in primary care, not in the hospital or outpatient clinic by a medical specialist
- Age between 40 and 80 years
Who cannot join
- Diabetes mellitus, as these patients are already included in a disease management program for diabetes mellitus
- Limited life expectancy, as assessed by the GP
- Cognitive impairment, as assessed by the GP
- No Dutch language proficiency
- Staying abroad for longer than three months during the duration of the study.
- The CV risk of the patient is managed in the hospital or outpatient clinic by a medical specialist
Trial locations and contacts
1 site in 1 country.
About this study
Cardiovascular disease (CVD) contributes importantly to mortality and morbidity. Prevention of CVD by lifestyle change and medication is important and needs full attention.
In the Netherlands an integrated program for cardiovascular risk management (CVRM), based on the Chronic Care Model (CCM), has been introduced in many regions in recent years, but evidence from studies that this approach is beneficial is very limited.
Read more
In the ZWOT-CASE study the investigators will assess the effect of integrated care for CVRM in the region of Zwolle on two major cardiovascular risk factors: systolic blood pressure (SBP) and low-density lipoprotein cholesterol (LDL-cholesterol) in patients with or at high risk of CVD.
This study is a pragmatic clinical trial comparing integrated care for CVRM with usual care among patients aged 40-80 years with CVD (n= 370) or with a high CVD risk (n= 370) within 26 general practices. After one year follow-up, primary outcomes (SBP and LDL-cholesterol level) are measured. Secondary outcomes include lifestyle habits (smoking, dietary habits, alcohol use, physical activity), risk factor awareness, 10-year risk of cardiovascular morbidity or mortality, health care consumption, patient satisfaction and quality of life.
- Conditions
- Cardiovascular Diseases, Hypercholesterolemia, Hypertension
- Being tested
- Integrated care for cardiovascular risk management
- Keywords
- Prevention, Disease Management, Integrated care, Primary Health Care
- Medical subject headings
- Cardiovascular Diseases, Hypercholesterolemia, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Integrated care for cardiovascular risk managementOther
Disease management program for the prevention of cardiovascular diseases
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | The intervention under study will be the integrated care for cardiovascular risk management (CVRM), based on the Dutch CVRM guideline. Patients with a history of cardiovascular disease (CVD), a high cardiovascular risk (CVR) (>10%) or use of antihypertensives or lipid lowering drugs are included in the program. Patients will be invited for an intake consultation, including a blood test, an interview, physical examination and estimation of the 10-years cardiovascular risk. If indicated, treatment with medication will be started and general lifestyle advises will be given. Patients can be referred to smoking cessation therapy, dietician and exercise programs or a physiotherapist. Patients will be controlled on a regular base to evaluate and adjust their personal goals. Receives: Other: Integrated care for cardiovascular risk management | |
| Control group | Usual care will be based on the Dutch CVRM guideline, describing how to calculate the CVR and advices to lower this risk by lifestyle intervention and/or medication. However systematic identification of patients eligible for CVRM, actively inviting patients for a visit, regular follow-up and standardized collaboration with other disciplines in the health care chain are not necessarily part of usual care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systolic blood pressure
Systolic blood pressure, manual or electronic oscillometric measurement, at least 2 measurements with an interval of 1-2 minutes
Measured: After 1 year of follow-up
LDL-cholesterol
Blood sample
Measured: After 1 year of follow-up
Secondary outcomes (31)
10-years cardiovascular morbidity or mortality risk
10-years cardiovascular morbidity or mortality risk (percentage) (Risk chart Dutch guideline or SMART risk score)
Measured: After 1 year of follow-up
Smoking status
Smoking yes or no
Measured: After 1 year of follow-up
Body mass index (BMI)
The BMI is defined as the body mass divided by the square of the body height, and is expressed in units of kg/m2, resulting from mass in kilograms and height in metres. BMI will be measured by the general practitioner or practice nurse during the endpoint visit
Measured: After 1 year of follow-up
Healthy diet
Healthy diet yes or no according to the Dutch guideline for cardiovascular risk management and national guideline for healthy diet ((daily 150 - 200 grams vegetables and 200 grams fruit; daily 30 - 40 grams dietary fibers; twice a week 100 - 150 gram fish, at least once fatty fish; maximum of 6 grams salt per day; maximum of 2 (men) or 1 (women) alcohol consumptions per day). Food habits will be measured by a questionairre.
Measured: After 1 year of follow-up
Physical activity
Squash questionnaire
Measured: After 1 year of follow-up
Motivation to quit smoking
Motivation to quit smoking: motivated to quit/not motivated to quit/ considers to quit smoking
Measured: After 1 year of follow-up
Awareness of received lifestyle advices
Aware/ not aware of received lifestyle advices, measured by questionairre
Measured: After 1 year of follow-up
Awareness of food habits
Patient will be asked whether he/she thinks if he/she has healthy food habits yes or no. Measured by a questionairre
Measured: After 1 year of follow-up
Awareness of physical activity
Patient will be asked whether he/she thinks if he/she has a healthy level of physical activity yes or no. Measured by a questionairre
Measured: After 1 year of follow-up
Awareness of weight
Patient will be asked whether he/she thinks if he/she has a healthy weight yes or no. Measured by a questionairre
Measured: After 1 year of follow-up
Awareness of hyperlipidaemia
Patient will be asked whether he/she thinks if he/she has hyperlipidaemia yes or no. Measured by a questionairre
Measured: After 1 year of follow-up
Awareness of cardiovascular disease risk
Estimation by patient of his/her own cardiovascular disease risk by a questionairre
Measured: After 1 year of follow-up
Awareness of hypertension
Patient will be asked whether he/she thinks if he/she has hypertension yes or no. Measured by a questionairre
Measured: After 1 year of follow-up
Use of adequate antihypertensives
Use of adequate antihypertensives according to Dutch guideline for cardiovascular risk management. Measured by medication registered in electronic medical records in general practice
Measured: After 1 year of follow-up
Use of adequate lipid lowering drugs
Use of adequate lipid lowering drugs according to Dutch guideline for cardiovascular risk management. Measured by medication registered in electronic medical records in general practice
Measured: After 1 year of follow-up
Use of adequate anticoagulants
Use of adequate anticoagulants according to Dutch guideline for cardiovascular risk management. Measured by medication registered in electronic medical records in general practice
Measured: After 1 year of follow-up
Morbidity
Newly developed cardiovascular diseases
Measured: After 1 year of follow-up
Newly developed diabetes mellitus
Newly developed diabetes mellitus, based on coded diagnosis in electronic medical record in general practice
Measured: After 1 year of follow-up
Newly developed COPD
Newly developed COPD, based on coded diagnosis in electronic medical record in general practice
Measured: After 1 year of follow-up
Newly developed heart failure
Newly developed heart failure, based on coded diagnosis in electronic medical record in general practice
Measured: After 1 year of follow-up
Newly developed atrial fibrillation
Newly developed atrial fibrillation, based on coded diagnosis in electronic medical record in general practice
Measured: After 1 year of follow-up
Mortality
Died due to cardiovascular disease or other cause
Measured: After 1 year of follow-up
Primary treating practitioner in the context of cardiovascular risk management
General practitioner or medical specialist.
Measured: After 1 year of follow-up
Health care consumption in the past year
Consultations in the contect ox cardiovascular risk management in general practice
Measured: After 1 year of follow-up
Self-management in the past year
Patient Activity Measure (PAM)
Measured: After 1 year of follow-up
Self-measurements of blood pressure in the past year
Self-measurements of blood pressure in the past year yes or no
Measured: After 1 year of follow-up
Patient satisfaction regarding the provided care in the past year
Patient Reported Experience Measure (PREM)
Measured: After 1 year of follow-up
Quality of life
EQ-5D
Measured: After 1 year of follow-up
Quality of life
SF-12
Measured: After 1 year of follow-up
Anxiety and depression
Hospital Anxiety and Depression Scale (HADS), 0-7: no depression or anxiety, 8-10: depression or anxiety is possible,11-21: depression or anxiety is likely
Measured: After 1 year of follow-up
Cost-efficiency
iPCQ
Measured: After 1 year of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2018
- Study start1 Sep 2017
- Primary completion31 Mar 2018 (estimated)
- Study completion31 Mar 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by UMC UtrechtThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 740 participants (estimated)
Sponsor and investigators
- Lead sponsor
- UMC Utrecht
- Sponsor type
- University, hospital or other
- Collaborators
- Isala, Medrie Health Care Group, Zwolle, Hein Hogerzeil Stichting
- Responsible party
- Principal investigator, Monika Hollander, MD, PhD, UMC Utrecht
- Investigators
- Arno Hoes, Prof. MD PhD, Study chair, Julius Center for Health Sciences and Primary Care/ University Medical Center UtrechtMonika Hollander, MD PhD, Principal investigator, Julius Center for Health Sciences and Primary Care/ University Medical Center UtrechtArnoud van 't Hof, Prof. MD PhD, Principal investigator, Maastricht University Medical Center, department of cardiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03428061
- Sponsor's protocol ID
- 57867
- Acronym
- ZWOT-CASE
- Status last verified
- Feb 2018
- First submitted
- 26 Jan 2018
- Last updated
- 9 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Piepoli MF, Hoes AW, Agewall S, Albus C, Brotons C, Catapano AL, Cooney MT, Corra U, Cosyns B, Deaton C, Graham I, Hall MS, Hobbs FDR, Lochen ML, Lollgen H, Marques-Vidal P, Perk J, Prescott E, Redon J, Richter DJ, Sattar N, Smulders Y, Tiberi M, van der Worp HB, van Dis I, Verschuren WMM. [2016 European guidelines on cardiovascular disease prevention in clinical practice. The Sixth Joint Task Force of the European Society of Cardiology and Other Societies on Cardiovascular Disease Prevention in Clinical Practice (constituted by representatives of 10 societies and by invited experts. Developed with the special contribution of the European Association for Cardiovascular Prevention & Rehabilitation]. G Ital Cardiol (Rome). 2017 Jul-Aug;18(7):547-612. doi: 10.1714/2729.27821. No abstract available. Italian.
PubMed 28714997Dyakova M, Shantikumar S, Colquitt JL, Drew CM, Sime M, MacIver J, Wright N, Clarke A, Rees K. Systematic versus opportunistic risk assessment for the primary prevention of cardiovascular disease. Cochrane Database Syst Rev. 2016 Jan 29;2016(1):CD010411. doi: 10.1002/14651858.CD010411.pub2.
PubMed 26824223Khunti K, Stone M, Paul S, Baines J, Gisborne L, Farooqi A, Luan X, Squire I. Disease management programme for secondary prevention of coronary heart disease and heart failure in primary care: a cluster randomised controlled trial. Heart. 2007 Nov;93(11):1398-405. doi: 10.1136/hrt.2006.106955. Epub 2007 Feb 19.
PubMed 17309907Ebrahim S, Taylor F, Ward K, Beswick A, Burke M, Davey Smith G. Multiple risk factor interventions for primary prevention of coronary heart disease. Cochrane Database Syst Rev. 2011 Jan 19;2011(1):CD001561. doi: 10.1002/14651858.CD001561.pub3.
PubMed 21249647Marchal S, Hollander M, Schoenmakers M, Schouwink M, Timmer JR, Bilo HJG, Schwantje O, van 't Hof AWJ, Hoes AW. Design of the ZWOT-CASE study: an observational study on the effectiveness of an integrated programme for cardiovascular risk management compared to usual care in general practice. BMC Fam Pract. 2019 Nov 1;20(1):149. doi: 10.1186/s12875-019-1039-z.
PubMed 31675925
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The ZWOlle Transmural Integrated Care for CArdiovaScular Risk Management Study
- ClinicalTrials.gov ID
- NCT03428061
- Acronym / sponsor ID
- ZWOT-CASE / 57867
- Conditions
- Cardiovascular Diseases, Hypercholesterolemia, Hypertension
- Keywords
- Prevention, Disease Management, Integrated care, Primary Health Care
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 740 participants (estimated)
- Lead sponsor
- UMC UtrechtUniversity, hospital or other
- Collaborators
- Isala, Medrie Health Care Group, Zwolle, Hein Hogerzeil Stichting
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 31 Mar 2018 (estimated)
- Study completion
- 31 Mar 2018 (estimated)
- First posted
- 9 Feb 2018 (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.
Cardiovascular disease (CVD) contributes importantly to mortality and morbidity. Prevention of CVD by lifestyle change and medication is important and needs full attention.
In the Netherlands an integrated program for cardiovascular risk management (CVRM), based on the Chronic Care Model (CCM), has been introduced in many regions in recent years, but evidence from studies that this approach is beneficial is very limited.
In the ZWOT-CASE study the investigators will assess the effect of integrated care for CVRM in the region of Zwolle on two major cardiovascular risk factors: systolic blood pressure (SBP) and low-density lipoprotein cholesterol (LDL-cholesterol) in patients with or at high risk of CVD.
This study is a pragmatic clinical trial comparing integrated care for CVRM with usual care among patients aged 40-80 years with CVD (n= 370) or with a high CVD risk (n= 370) within 26 general practices. After one year follow-up, primary outcomes (SBP and LDL-cholesterol level) are measured. Secondary outcomes include lifestyle habits (smoking, dietary habits, alcohol use, physical activity), risk factor awareness, 10-year risk of cardiovascular morbidity or mortality, health care consumption, patient satisfaction and quality of life.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | – | Other: Integrated care for cardiovascular risk managementThe intervention under study will be the integrated care for cardiovascular risk management (CVRM), based on the Dutch CVRM guideline. Patients with a history of cardiovascular disease (CVD), a high cardiovascular risk (CVR) (>10%) or use of antihypertensives or lipid lowering drugs are included in the program. Patients will be invited for an intake consultation, including a blood test, an interview, physical examination and estimation of the 10-years cardiovascular risk. If indicated, treatment with medication will be started and general lifestyle advises will be given. Patients can be referred to smoking cessation therapy, dietician and exercise programs or a physiotherapist. Patients will be controlled on a regular base to evaluate and adjust their personal goals. |
| Control group | – | –Usual care will be based on the Dutch CVRM guideline, describing how to calculate the CVR and advices to lower this risk by lifestyle intervention and/or medication. However systematic identification of patients eligible for CVRM, actively inviting patients for a visit, regular follow-up and standardized collaboration with other disciplines in the health care chain are not necessarily part of usual care. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The ZWOT-CASE study population will consist of a subgroup of 370 patients from the integrated CVRM care group (intervention) and 370 patients in the usual care (control) group. Both groups consist of respectively i) 185 patients with known CVD and ii) 185 patients with a high (>10%) ten year risk of CVD morbidity and mortality based on the Dutch Guideline for CVRM.
Key inclusion criteria (8 listed)
- Patients with a history of atherosclerotic CVD defined as documented angina pectoris, myocardial infarction, chronic ischemic heart disease, coronary sclerosis, transient ischaemic attack (TIA), cerebral infarction, intermittent claudication or aneurysm of the abdominal aorta
- The CV risk of the patient is managed in primary care, not in the hospital or outpatient clinic by a medical specialist
- Age between 40 and 80 years
- Use of blood pressure lowering or lipid lowering drugs
- A 10 -years CV risk > 10%, based on the Dutch guideline for CVRM and i) either 1 strongly cardiovascular risk enhancing factor or 2 mildly cardiovascular risk enhancing factors (see table 6) or ii) > 1 CV risk factor (current smoking, SBP>140 mmHg, LDL>2.5 mmol/L, TC/HDL-ratio > 8, chronic renal impairment (age < 65 years: eGFR < 60 ml/min/1,73 m2; age ≥ 65 years: eGFR < 45 ml/min/1,73 m2, and/or (micro)albuminuria).
Key exclusion criteria (6 listed)
- Diabetes mellitus, as these patients are already included in a disease management program for diabetes mellitus
- Limited life expectancy, as assessed by the GP
- Cognitive impairment, as assessed by the GP
- No Dutch language proficiency
- Staying abroad for longer than three months during the duration of the study.
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 |
|---|---|---|
| Integrated care for cardiovascular risk managementDisease management program for the prevention of cardiovascular diseases | Other | Intervention group |
Primary outcome
Systolic blood pressure
Time frame: After 1 year of follow-up
Systolic blood pressure, manual or electronic oscillometric measurement, at least 2 measurements with an interval of 1-2 minutes
LDL-cholesterol
Time frame: After 1 year of follow-up
Blood sample
31 secondary outcomes
10-years cardiovascular morbidity or mortality risk
Time frame: After 1 year of follow-up
Smoking status
Time frame: After 1 year of follow-up
Body mass index (BMI)
Time frame: After 1 year of follow-up
Healthy diet
Time frame: After 1 year of follow-up
Physical activity
Time frame: After 1 year of follow-up
Motivation to quit smoking
Time frame: After 1 year of follow-up
Awareness of received lifestyle advices
Time frame: After 1 year of follow-up
Awareness of food habits
Time frame: After 1 year of follow-up
Awareness of physical activity
Time frame: After 1 year of follow-up
Awareness of weight
Time frame: After 1 year of follow-up
Awareness of hyperlipidaemia
Time frame: After 1 year of follow-up
Awareness of cardiovascular disease risk
Time frame: After 1 year of follow-up
Awareness of hypertension
Time frame: After 1 year of follow-up
Use of adequate antihypertensives
Time frame: After 1 year of follow-up
Use of adequate lipid lowering drugs
Time frame: After 1 year of follow-up
Use of adequate anticoagulants
Time frame: After 1 year of follow-up
Morbidity
Time frame: After 1 year of follow-up
Newly developed diabetes mellitus
Time frame: After 1 year of follow-up
Newly developed COPD
Time frame: After 1 year of follow-up
Newly developed heart failure
Time frame: After 1 year of follow-up
Newly developed atrial fibrillation
Time frame: After 1 year of follow-up
Mortality
Time frame: After 1 year of follow-up
Primary treating practitioner in the context of cardiovascular risk management
Time frame: After 1 year of follow-up
Health care consumption in the past year
Time frame: After 1 year of follow-up
Self-management in the past year
Time frame: After 1 year of follow-up
Self-measurements of blood pressure in the past year
Time frame: After 1 year of follow-up
Patient satisfaction regarding the provided care in the past year
Time frame: After 1 year of follow-up
Quality of life
Time frame: After 1 year of follow-up
Quality of life
Time frame: After 1 year of follow-up
Anxiety and depression
Time frame: After 1 year of follow-up
Cost-efficiency
Time frame: After 1 year of follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2018.
- Background: PubMed 28714997Piepoli MF, Hoes AW, Agewall S, Albus C, Brotons C, Catapano AL, Cooney MT, Corra U, Cosyns B, Deaton C, Graham I, Hall MS, Hobbs FDR, Lochen ML, Lollgen H, Marques-Vidal P, Perk J, Prescott E, Redon J, Richter DJ, Sattar N, Smulders Y, Tiberi M, van der Worp HB, van Dis I, Verschuren WMM. [2016 European guidelines on cardiovascular disease prevention in clinical practice. The Sixth Joint Task Force of the European Society of Cardiology and Other Societies on Cardiovascular Disease Prevention in Clinical Practice (constituted by representatives of 10 societies and by invited experts. Developed with the special contribution of the European Association for Cardiovascular Prevention & Rehabilitation]. G Ital Cardiol (Rome). 2017 Jul-Aug;18(7):547-612. doi: 10.1714/2729.27821. No abstract available. Italian.
- Results publication: PubMed 26824223Dyakova M, Shantikumar S, Colquitt JL, Drew CM, Sime M, MacIver J, Wright N, Clarke A, Rees K. Systematic versus opportunistic risk assessment for the primary prevention of cardiovascular disease. Cochrane Database Syst Rev. 2016 Jan 29;2016(1):CD010411. doi: 10.1002/14651858.CD010411.pub2.
- Results publication: PubMed 17309907Khunti K, Stone M, Paul S, Baines J, Gisborne L, Farooqi A, Luan X, Squire I. Disease management programme for secondary prevention of coronary heart disease and heart failure in primary care: a cluster randomised controlled trial. Heart. 2007 Nov;93(11):1398-405. doi: 10.1136/hrt.2006.106955. Epub 2007 Feb 19.
- Results publication: PubMed 21249647Ebrahim S, Taylor F, Ward K, Beswick A, Burke M, Davey Smith G. Multiple risk factor interventions for primary prevention of coronary heart disease. Cochrane Database Syst Rev. 2011 Jan 19;2011(1):CD001561. doi: 10.1002/14651858.CD001561.pub3.
- Derived from this study: PubMed 31675925Marchal S, Hollander M, Schoenmakers M, Schouwink M, Timmer JR, Bilo HJG, Schwantje O, van 't Hof AWJ, Hoes AW. Design of the ZWOT-CASE study: an observational study on the effectiveness of an integrated programme for cardiovascular risk management compared to usual care in general practice. BMC Fam Pract. 2019 Nov 1;20(1):149. doi: 10.1186/s12875-019-1039-z.
- Individual participant dataSharing planned: No
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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.
Arno Hoes, Prof. MD PhD study chair
Julius Center for Health Sciences and Primary Care/ University Medical Center Utrecht
Monika Hollander, MD PhD principal investigator
Julius Center for Health Sciences and Primary Care/ University Medical Center Utrecht
Arnoud van 't Hof, Prof. MD PhD principal investigator
Maastricht University Medical Center, department of cardiology
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 Cardiovascular Diseases and Hypercholesterolemia, run by UMC Utrecht at 1 site in Netherlands.
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 8 inclusion and 6 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 9 Feb 2018. 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 Netherlands. 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?
Systolic blood pressure (time frame: After 1 year of follow-up). The study lists 2 primary outcomes in all. 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 NCT03428061, which also lists 5 linked publications.
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 9 Feb 2018.