Mobile Health in Structural Heart Disease (ASEF-VALUES)
Rheumatic Heart Disease, Heart Diseases
About this trial
This is an interventional diagnostic trial for Rheumatic Heart Disease focused on measuring Mobile Health, Telemedicine, Pocket-Echocardiography
Eligibility Criteria
Inclusion Criteria:
- Symptomatic outpatients with a new or an established diagnosis of rheumatic and structural heart disease and included valvular disease, left/right ventricular failure, rheumatic valvular disease, congenital heart defects and included adult, pediatric, and pregnant patients. Patients with a prior valvuloplasty or valve replacement for structural heart disease were also included
Exclusion Criteria:
- Exclusions included neonatal patients and those with an unstable hemodynamic status
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
mHealth
Standard-Care
Each participant randomized to a mHealth assessment were evaluated with: (1) structural abnormalities with handheld-echocardiography (Vscan®, General Electric Healthcare); (2) vital signs with smartphone-connected oxymetry and blood pressure monitors (iHealthLabs®); (3) functional assessments on a 6-minute walk test with a trial-axial activity monitor (Ozeri®); (4) cardiac rhythm abnormalities with smartphone-connected- iECG (AliveCor®) and; (5)point-of-care testing with fingerstick B-type natriuretic peptide (Alere). All study participants then underwent a comprehensive transthoracic echocardiogram for anatomical assessments of the severity of rheumatic and structural heart disease prior to percutaneous valvuloplasty or a surgical valve replacement.
Each participant randomized to a standard-assessment were evaluated with the resource available at the institution including a physical examination,12 lead-ECG, radiographic, laboratory testing as clinically required. All study participants underwent a comprehensive transthoracic echocardiogram for anatomical assessments of the severity of rheumatic and structural heart disease prior to percutaneous valvuloplasty or a surgical valve replacement.