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

June 21, 2022 updated by: Maria Papathanasiou, University Hospital, Essen

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • NRW
      • Essen, NRW, Germany, 45122
        • University Hospital Essen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Phosphodiesterase-5 inhibitor withdrawal
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
discontinuation of the oral medication with a phosphodiesterase-5 inhibitor

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
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
4 weeks after discontinuation of phosphodiesterase-5 inhibitors
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
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
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)
4 weeks after discontinuation of phosphodiesterase-5 inhibitors

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Essen

Investigators

  • Principal Investigator: Maria Papathanasiou, MD, University Hospital, Essen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 15, 2019

Primary Completion (Actual)

February 26, 2021

Study Completion (Actual)

March 15, 2021

Study Registration Dates

First Submitted

August 22, 2019

First Submitted That Met QC Criteria

October 3, 2019

First Posted (Actual)

October 7, 2019

Study Record Updates

Last Update Posted (Actual)

June 22, 2022

Last Update Submitted That Met QC Criteria

June 21, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 177923

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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