Clinical trial NCT04410718: Glycaemia and Cardiac Function in Patients With COVID-19
Official title: Glycaemia and Cardiac Function in Patients With COVID-19
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus
Diabetes Mellitus, Type 2
Diabetes Mellitus, Type 1
COVID
Lead sponsor: Steno Diabetes Center Copenhagen
Sponsor class: OTHER
First posted: 2020-06-01
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The present study aims to evaluate the effect of glycaemia on cardiac function in patients with COVID-19 by examining cardiac function by echocardiography in two patient groups: 1) hospitalised COVID-19 patients with diabetes admitted to the medical ward 2) COVID-19 patients with or without diabetes admitted to the ICU.

Brief summary: The study design is observational, exploratory study consisting of two cohorts of COVID-19 patients admitted to the ICU and the medical ward, respectively. The primary outcome focusing on the effect of plasma glucose levels on cardiac function will be evaluated by repeated assessment of cardiac function by echocardiography and measurement of plasma glucose. Furthermore, blood coagulability will be evaluated to determine the importance of diabetes status and plasma glucose changes for whole blood coagulability at time of admission to the ICU and progression in coagulability abnormalities. In the medical ward cohort, two assessments will be performed separated by no more than 12 hours. In the ICU cohort, three assessments will be performed separated by no more than 6 hours. Ideally, 60 patients with COVID-19 will be included in the ICU cohort with a 1:1 distribution between patient with and without diabetes. Ideally, 40 patients with diabetes will be included in the cohort of patients admitted to medical ward (hospitalisation cohort).

The primary hypothesis is that levels of plasma glucose have clinically significant impact on left ventricular systolic function in patients with COVID-19 admitted to the ICU. The secondary hypothesis is that the impact of plasma glucose on left ventricular systolic function is associated with glycaemic control prior to admission as measured by HbA1c.


Eligibility criteria: The ICU cohort - Inclusion criteria

* Informed and written consent
* Age ≥18 years
* Verified COVID-19
* Admission to the ICU within the last 24 hours
* Type 1 or type 2 diabetes prior to admission (the diabetes sub-group only)

The ICU cohort - Exclusion criteria

* Cardiac arrhythmia at time of inclusion (previously diagnosed paroxysmal atrial fibrillation will be allowed)
* Pacemaker rhythm
* Severe valve disease

The hospitalisation cohort - inclusion criteria

* Informed and written consent
* Age ≥18 years
* Verified COVID-19
* Admission to medical ward within the last 24 hours
* Type 1 or type 2 diabetes prior to admission

The hospitalisation cohort - Exclusion criteria

* Cardiac arrhythmia at time of inclusion (previously diagnosed paroxysmal atrial fibrillation will be allowed)
* Pacemaker rhythm
* Severe valve disease

Withdrawal criteria

- The participants may withdraw at will at any time

Primary outcomes:
measure: Plasma glucose levels and left ventricular ejection fraction
timeFrame: The study applies a mixed model for assessment of within-subject effects by repeated assessment in same individual. The time frame is from first assessment until last assessment (max. 24 hours).
Secondary outcomes:
measure: Key secondary outcome: HbA1c, plasma glucose levels and left ventricular systolic function
timeFrame: The study applies a mixed model for assessment of within-subject effects by repeated assessment in same individual. The time frame is from first assessment until last assessment (max. 24 hours).
measure: Plasma glucose levels and strain analysis
timeFrame: The study applies a mixed model for assessment of within-subject effects by repeated assessment in same individual. The time frame is from first assessment until last assessment (max. 24 hours).
measure: Plasma glucose levels and mitral annular systolic velocity
timeFrame: The study applies a mixed model for assessment of within-subject effects by repeated assessment in same individual. The time frame is from first assessment until last assessment (max. 24 hours).
measure: Plasma glucose levels and left ventricular ejection fraction (sub-group analysis)
timeFrame: The study applies a mixed model for assessment of within-subject effects by repeated assessment in same individual. The time frame is from first assessment until last assessment (max. 24 hours).
measure: Plasma glucose levels and strain analysis (sub-group analysis)
timeFrame: The study applies a mixed model for assessment of within-subject effects by repeated assessment in same individual. The time frame is from first assessment until last assessment (max. 24 hours).
measure: Plasma glucose levels and mitral annular systolic velocity (sub-group analysis)
timeFrame: The study applies a mixed model for assessment of within-subject effects by repeated assessment in same individual. The time frame is from first assessment until last assessment (max. 24 hours).
measure: HbA1c, Plasma glucose levels and strain analysis
timeFrame: The study applies a mixed model for assessment of within-subject effects by repeated assessment in same individual. The time frame is from first assessment until last assessment (max. 24 hours).
measure: HbA1c, Plasma glucose levels and mitral annular systolic velocity
timeFrame: The study applies a mixed model for assessment of within-subject effects by repeated assessment in same individual. The time frame is from first assessment until last assessment (max. 24 hours).
measure: Diabetes status and whole blood coagulability and fibrinolysis
timeFrame: At time of admission to the ICU (max. 24 hours after admission to the ICU)
measure: Diabetes status and change in whole blood coagulability and fibrinolysis during ICU stay
timeFrame: From first until last assessment during ICU stay (max. 24 hours).
measure: Prognostic value of TEG analysis
timeFrame: From time of admission and until four weeks after admission
measure: Prognostic value of cardiac function
timeFrame: From time of admission and until four weeks after admission
measure: Diabetes status and high-sensitivity troponins
timeFrame: At the time of admission to the ICU (max. 24 hours after admission to the ICU)
measure: Diabetes status and change high-sensitivity troponins
timeFrame: From first until last assessment during ICU stay (max. 24 hours)
Other outcomes:
Locations:
city: Hellerup
country: Denmark
facility: Herlev and Gentofte Hospital
state: Please Select
city: Hvidovre
country: Denmark
facility: Hvidovre Hospital
state: Please Select
Study officials:
References: