Clinical trial NCT04117659: Phosphodiesterase-5-inhibitors for Right Heart Failure After Left Ventricular Assist Device Implantation
Official title: Right Ventricular Function After Withdrawal of Phosphodiesterase-5 Inhibitors in Left Ventricular Assist Device Recipients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Phosphodiesterase Inhibitor Adverse Reaction
Right-Sided Heart Failure
Keywords: Left ventricular assist device
postoperative right heart failure
Lead sponsor: University Hospital, Essen
Sponsor class: OTHER
First posted: 2019-10-07
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: withdrawal of a pharmacologic therapy in pre-treated patients without control group
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline in right ventricular global longitudinal strain
timeFrame: 4 weeks after discontinuation of phosphodiesterase-5 inhibitors
Secondary outcomes:
measure: Change from baseline in peak oxygen uptake rate
timeFrame: 4 weeks after discontinuation of phosphodiesterase-5 inhibitors
measure: Change from baseline in 6-minute walking distance
timeFrame: 4 weeks after discontinuation of phosphodiesterase-5 inhibitors
measure: Change from baseline in the total score of quality of life calculated with the Kansas City Cardiomyopathy Questionnaire
timeFrame: 4 weeks after discontinuation of phosphodiesterase-5 inhibitors
Other outcomes:
Locations:
city: Essen
country: Germany
facility: University Hospital Essen
state: NRW
Study officials:
affiliation: University Hospital, Essen
name: Maria Papathanasiou, MD
role: PRINCIPAL_INVESTIGATOR
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