Rationale and design of a Global Rheumatic Heart Disease Registry: The REMEDY study

BACKGROUND: Rheumatic heart disease (RHD) is the principal cause of valvular heart disease-related mortality and morbidity in low- and middle-income countries. The disease predominantly affects children and young adults. It is estimated that RHD may potentially be responsible for 1.4 million deaths annually worldwide and 7.5% of all strokes occurring in developing countries. Despite the staggering global burden, there are no contemporary data documenting the presentation, clinical course, complications, and treatment practices among patients with RHD. METHODS: The REMEDY study is a prospective, international, multicenter, hospital-based registry planned in 2 phases: the vanguard phase involving centers in Africa and India will enroll 3,000 participants with RHD over a 1-year period. We will document clinical and echocardiographic characteristics of patients at presentation. Over a 2-year follow-up, we will document disease progression and treatment practices with particular reference to adherence to secondary prophylaxis and oral anticoagulation regimens. With 3,000 patients, we will be able to reliably determine the incidence of all-cause mortality, worsening heart failure requiring hospitalization, systemic embolism (including stroke), and major bleeding individually among all participants. We will identify barriers to care in a subgroup of 500 patients. CONCLUSION: The REMEDY study will provide comprehensive, contemporary data on patients with RHD and will help in the development of strategies to prevent and manage RHD and its complications.