Enhanced External Counterpulsation to Treat Long COVID-19 Fatigue (EXPECT)
Post-Acute COVID-19 Syndrome
About this trial
This is an interventional treatment trial for Post-Acute COVID-19 Syndrome focused on measuring long COVID, Enhanced eXternal counterpulsation
Eligibility Criteria
Inclusion Criteria: Patients recovering from PCR or lateral flow testing proven acute COVID-19 3-12 months following the acute infection Suffering from fatigue with a PROMIS-SF-7a T-score of > 50 Exclusion Criteria: Acute decompensated heart failure Recent myocardial infarction within the last 3 months Unstable angina pectoris Severe hypertension > 180/110 mm Hg Coagulopathy with international normalized ratio of prothrombin time > 2.0 Moderate to severe aortic regurgitation Abdominal aortic aneurysm (>5 mm) or dissection Arrhythmias that may interfere with triggering of EECP system (uncontrolled atrial fibrillation, flutter and very frequent premature ventricular contractions) Heart rate of <35 or >125 beats per minute Any surgical intervention within 6 weeks before EECP Recent cardiac catheterization (1-2 weeks) or arterial femoral puncture Severe peripheral arterial disease Severe venous disease (thrombophlebitis, prior or current deep vein thrombosis or pulmonary embolism) Severe chronic obstructive pulmonary disease Pregnancy or women of childbearing age who do not have a negative pregnancy test
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Experimental
Sham Comparator
Enhanced external counterpulsation
Sham procedure
Enhanced external counterpulsation (EECP/ECPT) is a non-invasive technique used to improve cardiac and cerebral perfusion. It aims to achieve 'diastolic augmentation' by increasing arterial blood pressure and retrograde aortic blood flow during diastole. This technique is currently used to treat refractory angina and heart failure, and was demonstrated to be well tolerated without limiting side effect. Practially, blood pressure cuffs are put along the lower limbs and are inflated to 300 mmHg pressure intermittently during one hour session. 15 sessions will be performed over 15 weeks.
The procedure will be identical to the experimental procedure, excluding the pressure that will reach only 80 mmHg.