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Completed

NCT Number: NCT04117659

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

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.

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Key information

Conditions

Phosphodiesterase Inhibitor Adverse Reaction Cardiovascular Diseases Heart Diseases Heart Failure Right-Sided Heart Failure

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Essen

Essen, North Rhine-Westphalia, 45122, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other

discontinuation of the oral medication with a phosphodiesterase-5 inhibitor

Primary outcomes

  1. Change from baseline in right ventricular global longitudinal strain

    Time frame: 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 outcomes

  1. Change from baseline in peak oxygen uptake rate

    Time frame: 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

  2. Change from baseline in 6-minute walking distance

    Time frame: 4 weeks after discontinuation of phosphodiesterase-5 inhibitors

    Change from baseline in walking distance assessed by 6-minute walking test

  3. Change from baseline in the total score of quality of life calculated with the Kansas City Cardiomyopathy Questionnaire

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

University Hospital, Essen

Other

Registry information

Official study title

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

Acronym: PIVAD

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Oct 7, 2019
Registry last updated
Jun 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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