Designing pulmonary arterial hypertension trials for detecting change in right ventricular function using cardiovascular magnetic resonance: what is the appropriate sample size?
نویسندگان
چکیده
Background Right ventricular (RV) failure is a major complication of pulmonary arterial hypertension (PAH). Cardiovascular magnetic resonance (CMR) can accurately quantify RV volume and function. Short-term changes in CMR measurements of RV size and function in PAH patients on individualized therapy have not been extensively studied; therefore, the required sample size for detecting a certain change in RV size and function in response to therapy is unknown. This study was designed to (1) assess changes in RV size and function in patients on individualized PAH treatment, and (2) to estimate sample sizes needed to detect a change in RV function in future PAH drug trials without discontinuing standard therapy.
منابع مشابه
Sample size and cost analysis for pulmonary arterial hypertension drug trials using various imaging modalities to assess right ventricular size and function end points.
BACKGROUND Placebo-controlled trials for pulmonary arterial hypertension are no longer acceptable because new therapies must show clinically significant effects on top of standard treatment. The purpose of this study was to estimate sample sizes and imaging costs for the planning of a hypothetical pulmonary arterial hypertension drug trial using imaging to detect changes in right ventricular si...
متن کاملRight ventricular Hemodynamic Alteration after Pulmonary Valve Replacement in Children with Congenital Heart Disease
Introduction: In patients who underwent surgery to repair Tetralogy of Fallot, right ventricular dilation from pulmonary regurgitation may be result in right ventricular failure, arrhythmias and cardiac arrest. Hence, pulmonary valve replacement may be necessary to reduce right ventricular volume overload. The aim of present study was to assess the effects of pulmonary valve replacement on rig...
متن کاملPrognostic value of cardiovascular magnetic resonance imaging measurements corrected for age and sex in idiopathic pulmonary arterial hypertension.
BACKGROUND There are limited data on the prognostic value of cardiovascular magnetic resonance measurements in idiopathic pulmonary arterial hypertension, with no studies investigating the impact of correction of cardiovascular magnetic resonance indices for age and sex on prognostic value. METHODS AND RESULTS Consecutive patients with idiopathic pulmonary arterial hypertension underwent card...
متن کاملBenefits from the correction of vitamin D deficiency in patients with pulmonary hypertension
Background: Vitamin D (Vit D) is linked to various conditions including musculoskeletal, metabolic and cardiopulmonary diseases. However, it is not clear whether correction of vit D deficiency exerts any beneficial effect in patients with pulmonary hypertension. Methods: This study was a prospective uncontrolled longitudinal study. Patients with pulmonary hypertension and vit D d...
متن کاملApplication of centrifugal pump in right ventricular failure due to pulmonary artery hypertension. (A case report)
Background: It has not been yet developed a ost suitable method to treat right ventricular failure due to pulmonar artery hypertention resulted from ventricular arrhythia. Though some case reports about patients ready to heart transplant using left assist device or biventral assist device as bridge have been published in Journals, but nocase concerning application of centrifugal pump for treatm...
متن کامل