COVID-19 Related Lockdown Effects On Chronic Diseases

Heart Failure Clinical Trial

— CLEO-CD  

Official title:

COVID-19 Related Lockdown Effects On Chronic Diseases

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04390126
• Other study ID #: BOULIN AOIc 2020
• Status: Active, not recruiting
• Start date: April 20, 2020
• Est. completion date: November 7, 2021

Study information

• Verified date: May 2020
• Source: Centre Hospitalier Universitaire Dijon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1200
• Est. completion date: November 7, 2021
• Est. primary completion date: May 7, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 9 Months and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• deceased patient, patient cannot be reached after >3 telephone calls, patient or caregiver does not speak French to carry out telephone interviews

Related Conditions & MeSH terms

• AMD and Macular Edema
• Chronic Coronary Syndrome
• Chronic Disease
• Chronic Respiratory Failure
• Giant Cell Arteritis
• Heart Failure
• Hemophilia
• Horton's Disease
• Macular Edema
• Malignant Hemopathy
• Multiple Sclerosis
• Polymyalgia Rheumatica
• Respiratory Insufficiency

Intervention

Other:
• life questionnaires
Telephone survey during the confinement period (common questionnaire and a questionnaire specific to the patient's pathology)
• questionnaire
1-year telephone diary to identify complications resulting in hospitalization related to the patient's chronic disease

Locations

Country	Name	City	State
France	CHU Dijon Bourgogne	Dijon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Dijon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	% adherence to each pharmacological class	increase in dose, decrease in dose, discontinuation or no change for each drug class)	during the period from 20 April 2020 to 7 May 2020
Primary	number of occurrence of medical events at 1 year	(mortality, hospitalizations and relevant criteria for each pathology all related to the chronic disease)	throughout the study for 12 months
Secondary	Expressed in %: Non-pharmacological treatment/lifestyle:	Smoking/Smoking/sweetening, Alcohol consumption/recovery, Decreased physical activity, Weight change	during the period from 20 April 2020 to 7 May 2020
Secondary	Expressed in %: Difficulties accessing care: medical appointments, prescriptions, medication		during the period from 20 April 2020 to 7 May 2020
Secondary	Measurement of psychological distress: Kessler's specific questionnaire (score between 0 and 24)		during the period from 20 April 2020 to 7 May 2020