Prospective Study of Persistent Dyspnea in Recovered COVID-19 Patients
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Covid19
- Sponsor
- Hospital Clínico Universitario de Valladolid
- Enrollment
- 70
- Locations
- 1
- Primary Endpoint
- Left Ventricular (LV) Function
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
We conducted a national, single center (Hospital Clínico Universitario de Valladolid, Spain, Valladolid), prospective study of patients with prior hospitalization because of COVID-19 who were admitted between March 1st, 2020, and May 15th, 2020. All eligible patients underwent at least at first-time follow-up from the index event. Exclusion criteria were age < 18 years old, pregnant women, terminally ill patients, active SARS-CoV-2 infections, inability to exercise and previous known severe pulmonary or heart disease. Patients underwent a clinical assessment for symptom burden, questionnaire for quality of life (Kansas City Cardiomyopathy Questionnaire and SF-36), venous blood sampling, 6-minute walking test (6-MWT), tests of lung function (spirometry and diffusing capacity of the lungs for carbon monoxide) and treadmill cardio-pulmonary exercise testing (CPET). 48-hours before the test of lung function and the CPET, all patients yielded a negative result in the reverse transcription-polymerase chain reaction (RT-PCR) for SARS-CoV-2. For definitive analysis patients were assigned to the control group if they did not refer dyspnea at the time of the follow-up, a small asymptomatic out-patient control group without prior hospitalization was also included.
Investigators
Ignacio J. Amat Santos
Coordinator of Interventional Cardiology Unit
Hospital Clínico Universitario de Valladolid
Eligibility Criteria
Inclusion Criteria
- •Signed Informed Consent
- •Previous COVID-19 hospitalization with successful discharged
- •Availability of at least one follow up per clinical protocol
Exclusion Criteria
- •pregnant women
- •terminally ill patients
- •active SARS-CoV-2 infections
- •inability to exercise
- •previous known severe pulmonary or heart disease
Outcomes
Primary Outcomes
Left Ventricular (LV) Function
Time Frame: 6 months
Left Ventricular (LV) Function (Ecocardiagraphy-measured Cardiac Function)
Aerobic capacity
Time Frame: 6 months
Measured as peak oxygen uptake
Total Lung Capacity (TLC)
Time Frame: 6 months
Pulmonary function test
Force Expiratory Volume in 1 second (FEV1)
Time Frame: 6 months
Pulmonary function test
Difussing Lung Capacity of CO (DLCO)
Time Frame: 6 months
Pulmonary function test
Forced Vital Capacity (FVC)
Time Frame: 6 months
Pulmonary function test
Right Ventricular (RV) Function
Time Frame: 6 months
Right Ventricular (RV) Function (Ecocardiagraphy-measured Cardiac Function)
Secondary Outcomes
- D-Dimer(6 months)
- Short Form 36 Health Survey (SF-36)(6 months)
- Kansas City Cardiomyopathy Questionnaire (KCCQ)(6 Months)
- interleukine-6(6 months)
- 6 Minute Walk Test(6 months)
- N-terminal pro hormone B-type natriuretic peptide (NT-proBNP)(6 months)
- Troponin-T(6 months)
- Ferritin(6 months)
- C reactive protein (CRP)(6 months)