The Chinese Pulmonary Vascular Disease Research Group is conducting a study to assess tolvaptan therapy for patients with right heart failure induced by pulmonary arterial hypertension (PAH).

Up to 100 study participants will be randomly assigned to receive 15 mg of tolvaptan and standard therapy with 20 to 40 mg of furosemide each day or the standard therapy alone within 12 hours of admission to the pulmonary vascular ward of Fuwai Hospital in Beijing, China. The therapy will be administered for 7 days with the aim of evaluating the safety and efficacy of tolvaptan for right heart failure in patients with PAH.

The 2 primary outcome measures of the trial are changes in body weight and urine volume after 7 days of treatment or on the day of hospital discharge. The secondary outcome measure is the change in renal function as measured by blood creatine levels.


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Tolvaptan is a vasopressin V2 receptor agonist for hyponatremia that increases the amount of sodium in the blood by increasing the amount of water released from the body in the urine. People with heart failure often have hyponatremia because the heart cannot sufficiently pump blood to all parts of the body.

Tolvaptan was approved by the US Food and Drug Administration (FDA) on May 19, 2009, and the European Medicines Agency (EMA) on August 2, 2009.

Read more about PAH treatment

The prospective, open-label, randomized controlled study started on April 6, 2021, and is expected to be completed on December 31, 2022. The researchers plan to enroll 100 participants aged 18 or more years.

PAH is a progressive form of pulmonary hypertension characterized by the thickening and narrowing of the pulmonary arteries, leading to increased pulmonary vascular resistance and right heart failure. There are 4 main types of PAH: idiopathic, familial, drug- or toxin-induced, and PAH associated with other diseases (eg, connective tissue disorders, human immunodeficiency virus infection, congenital heart disease, or portal hypertension).

Reference

Efficacy and safety evaluation of tolvaptan in the treatment of patients with RHF caused by PAH. ClinicalTrials.gov. October 6, 2022. Accessed October 13, 2022.