This study is an early feasibility study which typically consist of evaluating innovative devices or innovative uses of approved devices. The purpose of this study is to see if an investigational device called preCARDIA Intermittent Balloon Device can limit fluid overload in congested patients with advanced heart failure. This investigational device is a catheter which has been approved by the U.S. Food and Drug Administration (FDA) to occlude large vessels but not for the treatment of advanced heart failure. Currently, there are no device-based approaches that are FDA-approved for advanced heart failure. This study will help find out if this device-based approach can improve symptoms and heart function in congested patients with advanced heart failure
This research study aims to determine a less invasive way to assess heart function by taking measurements of the heart while subjects are performing an exercise cardiac MRI. Subjects will undergo two exercise phases and MRI measurements will be taken after each exercise phase. These measurements will be compared to available clinical data (including demographic, hemodynamic, radiologic, and functional) and future outcome data.
Elevated pressures in the heart can represent a severe medical condition known as pulmonary hypertension. This can result in chronic right heart failure. An abnormal increase in this pressure during exercise may be represent an early stage of vascular lung disease. This study will investigate the prognostic implications of the measured pressures obtained during exercise while undergoing a right heart catheterization procedure based on a large scale multi-center approach by using retrospective and prospective analysis of hemodynamic data.
The purpose of this study is to find out if levosimendan is safe and effective in improving symptoms and outcomes for patients with PH-HFpEF who have previously participated in the TNX-LVO-04 study. All patients who are enrolled in this study will receive levosimendan weekly through a 24 hour infusion at their home. Office visits will occur at weeks 3, 6, 12, 24, 48, and final visit.
Patients with systemic sclerosis (SSc) related pulmonary arterial hypertension (SScPAH) have a worse prognosis than those with idiopathic PAH. We have recently discovered that heart cells in SScPAH do not contract or squeeze as well as in other forms of pulmonary hypertension. However, the mechanism leading to this dysfunction is not understood. To better study this and in hopes of developing a future therapy, we plan to collect tissue samples via a heart biopsy at the time of a clinically indicated heart catheterization.