NCT04117659

Phosphodiesterase-5-inhibitors for Right Heart Failure After Left Ventricular Assist Device Implantation

Right Ventricular Function After Withdrawal of Phosphodiesterase-5 Inhibitors in Left Ventricular Assist Device Recipients

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: University Hospital, Essen · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Refractory right heart failure is common during the postoperative period after left ventricular assist device implantation. Oral phosphodiesterase-5 inhibitors are oft initiated in order to facilitate weaning from the intravenous inotropic substances. following this period many patients continue to receive the same medication in the long term, despite missing data on its therapeutic effect on right ventricular function.We hypothesise that beyond the acute postoperative period no additional benefit from the phosphodiesterase-5 inhibitors exists. The aim of the study is a detailed clinical and echocardiographic assessment of the right ventricular function after discontinuation of the medication in patients pretreated for at least one month after receiving left ventricular assist device.

Detailed description

The study aims to assess clinical and echocardiographic measures of right ventricular function before and after discontinuation of the oral phosphodiesterase-5 inhibitor in patients on left ventricular device support. At baseline and after discontinuation of the medication patients will receive a clinical examination and New York Heart Association Classification, echocardiographic assessment of right ventricular function, cardiopulmonary exercise testing, 6 minute walking test and assessment of quality of life. The primary outcome is the change of the quantitative echocardiographic parameters of right ventricular function at follow-up. Secondarily, we aim to assess the change in cardiopulmonary exercise capacity, the 6-minute walking distance and quality of life.

Conditions

• Phosphodiesterase Inhibitor Adverse Reaction
• Right-Sided Heart Failure

Interventions

Type	Name	Description
OTHER	withdrawal of oral medication (phosphodiesterase-5 inhibitor) in pretreated patients	discontinuation of the oral medication with a phosphodiesterase-5 inhibitor

Timeline

• Start date: 2019-10-15
• Primary completion: 2021-02-26
• Completion: 2021-03-15
• First posted: 2019-10-07
• Last updated: 2022-06-22

Locations

1 site across 1 country: Germany