Prospective Study of Persistent Dyspnea in Recovered COVID-19 Patients
- Conditions
- DyspneaCovid19
- Interventions
- Diagnostic Test: Cardiopulmonary exercise test
- Registration Number
- NCT04689490
- Lead Sponsor
- Hospital Clínico Universitario de Valladolid
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 70
- Signed Informed Consent
- Previous COVID-19 hospitalization with successful discharged
- Availability of at least one follow up per clinical protocol
- pregnant women
- terminally ill patients
- active SARS-CoV-2 infections
- inability to exercise
- previous known severe pulmonary or heart disease
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Control Cardiopulmonary exercise test Patients with prior hospitalization because of COVID-19, with succesful hospital discharge, who underwent at least a first-time follow-up from the index event, fully recovered, without persistent dyspnea. Dyspnea Cardiopulmonary exercise test Patients with prior hospitalization because of COVID-19, with succesful hospital discharge, who underwent at least a first-time follow-up from the index event, and present persistent dyspnea.
- Primary Outcome Measures
Name Time Method Difussing Lung Capacity of CO (DLCO) 6 months Pulmonary function test
Left Ventricular (LV) Function 6 months Left Ventricular (LV) Function (Ecocardiagraphy-measured Cardiac Function)
Forced Vital Capacity (FVC) 6 months Pulmonary function test
Aerobic capacity 6 months Measured as peak oxygen uptake
Total Lung Capacity (TLC) 6 months Pulmonary function test
Force Expiratory Volume in 1 second (FEV1) 6 months Pulmonary function test
Right Ventricular (RV) Function 6 months Right Ventricular (RV) Function (Ecocardiagraphy-measured Cardiac Function)
- Secondary Outcome Measures
Name Time Method interleukine-6 6 months Inflammatory and Cardiac Marker
6 Minute Walk Test 6 months Walking capacity
N-terminal pro hormone B-type natriuretic peptide (NT-proBNP) 6 months Inflammatory and Cardiac Marker
Ferritin 6 months Inflammatory and Cardiac Marker
C reactive protein (CRP) 6 months Inflammatory and Cardiac Marker
D-Dimer 6 months Inflammatory and Cardiac Marker
Short Form 36 Health Survey (SF-36) 6 months Quality of Life test
Kansas City Cardiomyopathy Questionnaire (KCCQ) 6 Months Quality of Life test
Troponin-T 6 months Inflammatory and Cardiac Marker
Trial Locations
- Locations (1)
Hospital Clínico Universitario de Valladolid
🇪🇸Valladolid, Spain