Phosphodiesterase Inhibitor Adverse Reaction, Right-Sided Heart Failure
Conditions
Keywords
Left ventricular assist device, postoperative right heart failure
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.
Interventions
OTHERwithdrawal of oral medication (phosphodiesterase-5 inhibitor) in pretreated patients
discontinuation of the oral medication with a phosphodiesterase-5 inhibitor
Sponsors
University Hospital, Essen
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
withdrawal of a pharmacologic therapy in pre-treated patients without control group
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Countries
Germany
Outcome results
None listed