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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Phosphodiesterase Inhibitor Adverse Reaction, Right-Sided Heart Failure

Intervention / Treatment
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* Other: withdrawal of oral medication (phosphodiesterase-5 inhibitor) in pretreated patients


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Interventional Model Description: withdrawal of a pharmacologic therapy in pre-treated patients without control group
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Phosphodiesterase-5 inhibitor withdrawal<br>In this single arm pretreatment with an oral phosphodiesterase-5 inhibitor will be discontinued | Other: withdrawal of oral medication (phosphodiesterase-5 inhibitor) in pretreated patients<br>* discontinuation of the oral medication with a phosphodiesterase-5 inhibitor<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in peak oxygen uptake rate | Change from baseline in functional status as estimated by peak oxygen uptake rate in cardiopulmonary exercise testing | 4 weeks after discontinuation of phosphodiesterase-5 inhibitors | 
| Change from baseline in 6-minute walking distance | Change from baseline in walking distance assessed by 6-minute walking test | 4 weeks after discontinuation of phosphodiesterase-5 inhibitors | 
| Change from baseline in the total score of quality of life calculated with the Kansas City Cardiomyopathy Questionnaire | 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) | 4 weeks after discontinuation of phosphodiesterase-5 inhibitors | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Left ventricular assist device, postoperative right heart failure