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Clinical Trials/NCT04689490
NCT04689490
Completed
Not Applicable

Prospective Study of Persistent Dyspnea in Recovered COVID-19 Patients

Hospital Clínico Universitario de Valladolid1 site in 1 country70 target enrollmentAugust 1, 2020
ConditionsCovid19Dyspnea

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.

Registry
clinicaltrials.gov
Start Date
August 1, 2020
End Date
December 31, 2020
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

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)

Study Sites (1)

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