Study of Oral Inorganic Nitrate Therapy in Adults With Intermediate High-risk Pulmonary Embolism to Improve Heart and Lung Function

What this Trial Is About

Researchers are investigating the effects of oral inorganic nitrates in adults with intermediate high-risk pulmonary embolism PE, a serious condition where blood clots block lung vessels, causing strain on the right side of the heart. This trial aims to better understand invasive hemodynamic changes in these patients and evaluate the safety and physiological effects of inorganic nitrate treatment compared to placebo. The study focuses on patients with signs of right heart stress and elevated cardiac biomarkers despite standard anticoagulation treatment. The trial is a multicenter, double-blind, randomized controlled study where participants receive either nitrate-rich beetroot juice or a visually matched placebo daily for five days. All patients undergo right heart catheterization to measure pressures and blood flow at baseline, three hours after treatment, and at 24 hours. The primary outcome is the mean pulmonary artery pressure measured three hours after the first treatment dose. Secondary outcomes include detailed hemodynamic measurements, blood biomarkers, echocardiographic assessments, and safety monitoring. Participants will be admitted to intensive or high dependency care units and receive standard anticoagulation therapy alongside study treatments. Researchers will monitor invasive heart and lung pressures, blood and saliva nitrate levels, heart function by echocardiography, and clinical safety outcomes such as low blood pressure and complications from catheterization. The study continues through the five-day treatment period, aiming to clarify whether inorganic nitrate therapy is safe, feasible, and beneficial in this patient group.

Inorganic Nitrates in Intermediate High-risk Pulmonary Embolism