Chronic Coronary SyndromeCLEO-CDNCT04390126
COVID-19 Related Lockdown Effects On Chronic Diseases
An observational study of Chronic Coronary Syndrome and Heart Failure, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial summary
The containment associated with the VIDOC-19 pandemic creates an unprecedented societal situation of physical and social isolation. Our hypothesis is that in patients with chronic diseases, confinement leads to changes in health behaviours, adherence to pharmacological treatment, lifestyle rules and increased… Read more about this study
- Who is it for?
- Ages 9 months and older
- Conditions the study is for
- Chronic Coronary Syndrome, Heart Failure, AMD and Macular Edema
- What is being tested?
- life questionnaires and questionnaire
- How many people
- 1,343 participants
- Where
- 1 siteFrance
- Study dates
- 14 Apr 2020to 2 Jun 2020
- 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 9 months and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: patients from existing registries or cohorts
Who may be able to join
- patients with one of the following chronic diseases: chronic coronary syndrome, heart failure, multiple sclerosis, Horton's disease, AMD, malignant haemopathy, chronic respiratory failure (idiopathic fibrosis, PAH, haemophilia) and already registered in one of the 8 Burgundian registries/cohorts.
Who cannot join
- deceased patient, patient cannot be reached after >3 telephone calls, patient or caregiver does not speak French to carry out telephone interviews
Trial locations and contacts
1 site in 1 country.
About this study
The containment associated with the VIDOC-19 pandemic creates an unprecedented societal situation of physical and social isolation. Our hypothesis is that in patients with chronic diseases, confinement leads to changes in health behaviours, adherence to pharmacological treatment, lifestyle rules and increased psychosocial stress with an increased risk of deterioration in their health status in the short, medium and long term.
Some messages about the additional risk/danger associated with taking certain drugs in the event of COVID disease have been widely disseminated in the media since March 17, 2020, the date on which containment began in France. This is the case, for example, for corticosteroids, non-steroidal anti-inflammatory drugs but also for converting enzyme inhibitors (ACE inhibitors) and angiotensin II receptor antagonists (ARBs2). These four major classes of drugs are widely prescribed in patients with chronic diseases, diseases specifically selected in our study (corticosteroids: haematological malignancies, multiple sclerosis, Horton's disease; ACE inhibitors/ARAs2: heart failure, chronic coronary artery disease). Aspirin used at low doses as an anti-platelet agent in coronary patients as a secondary prophylaxis after a myocardial infarction can be stopped by some patients who consider aspirin to be a non-steroidal anti-inflammatory drug. Discontinuation of this antiplatelet agent, which must be taken for life after an infarction, exposes the patient to a major risk of a new cardiovascular event.
Read more
The current difficulty of access to care due to travel restrictions (a theoretical limit in the context of French confinement but a priori very real), the impossibility of consulting overloaded doctors, or the cancellation of medical appointments, medical and surgical procedures due to the reorganization of our hospital and private health system to better manage COVID-19 patients also increases the risk of worsening the health status of chronic patients who by definition require regular medical monitoring.
Eight Burgundian cohorts of patients with chronic diseases (chronic coronary artery disease, heart failure, multiple sclerosis, Horton's disease, AMD, haemopathic malignancy, chronic respiratory failure (idiopathic fibrosis, PAH) haemophilia cohort) will study the health impact of the containment related to the COVID-19 pandemic.
- Conditions
- Chronic Coronary Syndrome, Heart Failure, AMD and Macular Edema, Chronic Respiratory Failure, Hemophilia, Malignant Hemopathy
- Being tested
- life questionnaires, questionnaire
- Medical subject headings
- Heart Failure, Macular Edema, Hemophilia A, Multiple Sclerosis, Giant Cell Arteritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
life questionnairesOther
Telephone survey during the confinement period (common questionnaire and a questionnaire specific to the patient's pathology)
questionnaireOther
1-year telephone diary to identify complications resulting in hospitalization related to the patient's chronic disease
| Study group | Role | What they receive |
|---|---|---|
| Register of haematological malignancies | Not described Receives: Other: life questionnaires; Other: questionnaire | |
| Idiopathic Pulmonary Fibrosis and PAH Cohort | Not described Receives: Other: life questionnaires; Other: questionnaire | |
| Giant Cell Arteritis Cohort | Not described Receives: Other: life questionnaires; Other: questionnaire | |
| AMD and Macular Edema Cohort | Not described Receives: Other: life questionnaires; Other: questionnaire | |
| Multiple Sclerosis Cohort | Not described Receives: Other: life questionnaires; Other: questionnaire | |
| Myocardial Infarction Observatory RICO | Not described Receives: Other: life questionnaires; Other: questionnaire | |
| Heart Failure Cohort | Not described Receives: Other: life questionnaires; Other: questionnaire | |
| Hemophilia Cohort | Not described Receives: Other: life questionnaires; Other: questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
% adherence to each pharmacological class
increase in dose, decrease in dose, discontinuation or no change for each drug class)
Measured: during the period from 20 April 2020 to 7 May 2020
number of occurrence of medical events at 1 year
(mortality, hospitalizations and relevant criteria for each pathology all related to the chronic disease)
Measured: throughout the study for 12 months
Secondary outcomes (3)
Expressed in %: Non-pharmacological treatment/lifestyle:
Smoking/Smoking/sweetening, Alcohol consumption/recovery, Decreased physical activity, Weight change
Measured: during the period from 20 April 2020 to 7 May 2020
Expressed in %: Difficulties accessing care: medical appointments, prescriptions, medication
Measured: during the period from 20 April 2020 to 7 May 2020
Measurement of psychological distress: Kessler's specific questionnaire (score between 0 and 24)
Measured: during the period from 20 April 2020 to 7 May 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2020
- Study start14 Apr 2020
- Primary completion2 Jun 2020
- Study completion2 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Coronary SyndromeStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe 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
- 1,343 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04390126
- Sponsor's protocol ID
- BOULIN AOIc 2020
- Acronym
- CLEO-CD
- Status last verified
- Jan 2026
- First submitted
- 14 May 2020
- Last updated
- 2 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Boulin M, Cransac-Miet A, Maynadie M, Volot F, Creuzot-Garcher C, Eicher JC, Chague F, Ksiazek E, Beltramo G, Bonniaud P, Moreau T, Bonnotte B, Sales-Wuillemin E, Soudry-Faure A, Zeller M, Cottin Y. COVID-19 Lockdown in Patients with Chronic Diseases: A Cross-Sectional Study. Int J Environ Res Public Health. 2022 Mar 26;19(7):3957. doi: 10.3390/ijerph19073957.
PubMed 35409640Volot F, Soudry-Faure A, Callegarin A, Ksiazek E, Delienne S, Cottin Y, Maynadie M, Boulin M. Impact of first COVID-19 lockdown on paediatric and adult haemophilia patients treated in a French Haemophilia Comprehensive Care Centre. Haemophilia. 2022 May;28(3):462-471. doi: 10.1111/hae.14526. Epub 2022 Mar 3.
PubMed 35238436
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COVID-19 Related Lockdown Effects On Chronic Diseases
- ClinicalTrials.gov ID
- NCT04390126
- Acronym / sponsor ID
- CLEO-CD / BOULIN AOIc 2020
- Conditions
- Chronic Coronary Syndrome, Heart Failure, AMD and Macular Edema, Chronic Respiratory Failure, Hemophilia, Malignant Hemopathy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,343 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 14 Apr 2020 (actual)
- Primary completion
- 2 Jun 2020 (actual)
- Study completion
- 2 Jun 2020 (actual)
- First posted
- 15 May 2020 (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 containment associated with the VIDOC-19 pandemic creates an unprecedented societal situation of physical and social isolation. Our hypothesis is that in patients with chronic diseases, confinement leads to changes in health behaviours, adherence to pharmacological treatment, lifestyle rules and increased psychosocial stress with an increased risk of deterioration in their health status in the short, medium and long term.
Some messages about the additional risk/danger associated with taking certain drugs in the event of COVID disease have been widely disseminated in the media since March 17, 2020, the date on which containment began in France. This is the case, for example, for corticosteroids, non-steroidal anti-inflammatory drugs but also for converting enzyme inhibitors (ACE inhibitors) and angiotensin II receptor antagonists (ARBs2). These four major classes of drugs are widely prescribed in patients with chronic diseases, diseases specifically selected in our study (corticosteroids: haematological malignancies, multiple sclerosis, Horton's disease; ACE inhibitors/ARAs2: heart failure, chronic coronary artery disease). Aspirin used at low doses as an anti-platelet agent in coronary patients as a secondary prophylaxis after a myocardial infarction can be stopped by some patients who consider aspirin to be a non-steroidal anti-inflammatory drug. Discontinuation of this antiplatelet agent, which must be taken for life after an infarction, exposes the patient to a major risk of a new cardiovascular event.
The current difficulty of access to care due to travel restrictions (a theoretical limit in the context of French confinement but a priori very real), the impossibility of consulting overloaded doctors, or the cancellation of medical appointments, medical and surgical procedures due to the reorganization of our hospital and private health system to better manage COVID-19 patients also increases the risk of worsening the health status of chronic patients who by definition require regular medical monitoring.
Eight Burgundian cohorts of patients with chronic diseases (chronic coronary artery disease, heart failure, multiple sclerosis, Horton's disease, AMD, haemopathic malignancy, chronic respiratory failure (idiopathic fibrosis, PAH) haemophilia cohort) will study the health impact of the containment related to the COVID-19 pandemic.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Register of haematological malignancies | – | Other: life questionnaires, Other: questionnaire |
| Idiopathic Pulmonary Fibrosis and PAH Cohort | – | Other: life questionnaires, Other: questionnaire |
| Giant Cell Arteritis Cohort | – | Other: life questionnaires, Other: questionnaire |
| AMD and Macular Edema Cohort | – | Other: life questionnaires, Other: questionnaire |
| Multiple Sclerosis Cohort | – | Other: life questionnaires, Other: questionnaire |
| Myocardial Infarction Observatory RICO | – | Other: life questionnaires, Other: questionnaire |
| Heart Failure Cohort | – | Other: life questionnaires, Other: questionnaire |
| Hemophilia Cohort | – | Other: life questionnaires, Other: questionnaire |
Who may qualify
- Ages
- 9 months and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients from existing registries or cohorts
Key inclusion criteria (1 listed)
- patients with one of the following chronic diseases: chronic coronary syndrome, heart failure, multiple sclerosis, Horton's disease, AMD, malignant haemopathy, chronic respiratory failure (idiopathic fibrosis, PAH, haemophilia) and already registered in one of the 8 Burgundian registries/cohorts.
Key exclusion criteria (1 listed)
- deceased patient, patient cannot be reached after >3 telephone calls, patient or caregiver does not speak French to carry out telephone interviews
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 |
|---|---|---|
| life questionnairesTelephone survey during the confinement period (common questionnaire and a questionnaire specific to the patient's pathology) | Other | AMD and Macular Edema Cohort, Giant Cell Arteritis Cohort, Heart Failure Cohort, Hemophilia Cohort, Idiopathic Pulmonary Fibrosis and PAH Cohort, Multiple Sclerosis Cohort, Myocardial Infarction Observatory RICO, Register of haematological malignancies |
| questionnaire1-year telephone diary to identify complications resulting in hospitalization related to the patient's chronic disease | Other | AMD and Macular Edema Cohort, Giant Cell Arteritis Cohort, Heart Failure Cohort, Hemophilia Cohort, Idiopathic Pulmonary Fibrosis and PAH Cohort, Multiple Sclerosis Cohort, Myocardial Infarction Observatory RICO, Register of haematological malignancies |
Primary outcome
% adherence to each pharmacological class
Time frame: during the period from 20 April 2020 to 7 May 2020
increase in dose, decrease in dose, discontinuation or no change for each drug class)
number of occurrence of medical events at 1 year
Time frame: throughout the study for 12 months
(mortality, hospitalizations and relevant criteria for each pathology all related to the chronic disease)
3 secondary outcomes
Expressed in %: Non-pharmacological treatment/lifestyle:
Time frame: during the period from 20 April 2020 to 7 May 2020
Expressed in %: Difficulties accessing care: medical appointments, prescriptions, medication
Time frame: during the period from 20 April 2020 to 7 May 2020
Measurement of psychological distress: Kessler's specific questionnaire (score between 0 and 24)
Time frame: during the period from 20 April 2020 to 7 May 2020
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2026.
- Results publication: PubMed 35409640Boulin M, Cransac-Miet A, Maynadie M, Volot F, Creuzot-Garcher C, Eicher JC, Chague F, Ksiazek E, Beltramo G, Bonniaud P, Moreau T, Bonnotte B, Sales-Wuillemin E, Soudry-Faure A, Zeller M, Cottin Y. COVID-19 Lockdown in Patients with Chronic Diseases: A Cross-Sectional Study. Int J Environ Res Public Health. 2022 Mar 26;19(7):3957. doi: 10.3390/ijerph19073957.
- Derived from this study: PubMed 35238436Volot F, Soudry-Faure A, Callegarin A, Ksiazek E, Delienne S, Cottin Y, Maynadie M, Boulin M. Impact of first COVID-19 lockdown on paediatric and adult haemophilia patients treated in a French Haemophilia Comprehensive Care Centre. Haemophilia. 2022 May;28(3):462-471. doi: 10.1111/hae.14526. Epub 2022 Mar 3.
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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.
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 Chronic Coronary Syndrome and Heart Failure, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
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 1 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: finished, as of the sponsor's last update on 2 Feb 2026. 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 France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
% adherence to each pharmacological class (time frame: during the period from 20 April 2020 to 7 May 2020). 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 NCT04390126, which also lists 2 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 2 Feb 2026.