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

University Hospital Essen

Status: Completed

Conditions: Right-Sided Heart Failure; Phosphodiesterase Inhibitor Adverse Reaction

Treatments: Other: withdrawal of oral medication (phosphodiesterase-5 inhibitor) in pretreated patients

Study type: Interventional

Funder types: Other

Identifiers

NCT04117659

177923

Details and patient eligibility

About

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.

Full 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.

Enrollment: 32 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age >18 y.o.
• clinically stable, ambulatory heart failure patients on left ventricular assist device support
• implantation > 1 month before inclusion in the study
• uninterrupted therapy with an oral phosphodiesterase-5 inhibitor initiated during the early postoperativ period due to right heart failure

Exclusion criteria

• unable to provide written informed consent
• refusal to provide written informed consent

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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32 participants in 1 patient group

Phosphodiesterase-5 inhibitor withdrawal

Experimental group

Description:

In this single arm pretreatment with an oral phosphodiesterase-5 inhibitor will be discontinued

Treatment:

Other: withdrawal of oral medication (phosphodiesterase-5 inhibitor) in pretreated patients