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

Not Applicable

Completed

• Conditions: Right-Sided Heart Failure; Phosphodiesterase Inhibitor Adverse Reaction
• Interventions: Other: withdrawal of oral medication (phosphodiesterase-5 inhibitor) in pretreated patients

• Registration Number: NCT04117659
• Lead Sponsor: University Hospital, Essen

Brief 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.

Study Timeline

• Study First Submitted: 2019-08-22
• Study First Submitted QC: 2019-10-03
• Study First Posted: 2019-10-07
• Study Start: 2019-10-15
• Primary Completion: 2021-02-26
• Study Completion: 2021-03-15
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-21
• Last Update Posted: 2022-06-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Phosphodiesterase-5 inhibitor withdrawal	withdrawal of oral medication (phosphodiesterase-5 inhibitor) in pretreated patients	In this single arm pretreatment with an oral phosphodiesterase-5 inhibitor will be discontinued

Primary Outcome Measures

Name	Time	Method
Change from baseline in right ventricular global longitudinal strain	4 weeks after discontinuation of phosphodiesterase-5 inhibitors	Change in right ventricular function from baseline as assessed by global longitudinal strain of the right ventricle on transthoracic echocardiography

Secondary Outcome Measures

Name	Time	Method
Change from baseline in peak oxygen uptake rate	4 weeks after discontinuation of phosphodiesterase-5 inhibitors	Change from baseline in functional status as estimated by peak oxygen uptake rate in cardiopulmonary exercise testing
Change from baseline in 6-minute walking distance	4 weeks after discontinuation of phosphodiesterase-5 inhibitors	Change from baseline in walking distance assessed by 6-minute walking test
Change from baseline in the total score of quality of life calculated with the Kansas City Cardiomyopathy Questionnaire	4 weeks after discontinuation of phosphodiesterase-5 inhibitors	Change from baseline in the total score calculated with the Kansas City Cardiomyopathy Questionnaire (range between 0 and 100, higher value indicates worse status of quality of life)

Trial Locations

Locations (1)

University Hospital Essen; 🇩🇪 Essen, NRW, Germany