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

Primary Purpose

Phosphodiesterase Inhibitor Adverse Reaction, Right-Sided Heart Failure

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
withdrawal of oral medication (phosphodiesterase-5 inhibitor) in pretreated patients
Sponsored by
University Hospital, Essen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Phosphodiesterase Inhibitor Adverse Reaction focused on measuring Left ventricular assist device, postoperative right heart failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital Essen

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Phosphodiesterase-5 inhibitor withdrawal

Arm Description

In this single arm pretreatment with an oral phosphodiesterase-5 inhibitor will be discontinued

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
Change from baseline in 6-minute walking distance
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
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)

Full Information

First Posted
August 22, 2019
Last Updated
June 21, 2022
Sponsor
University Hospital, Essen
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1. Study Identification

Unique Protocol Identification Number
NCT04117659
Brief Title
Phosphodiesterase-5-inhibitors for Right Heart Failure After Left Ventricular Assist Device Implantation
Acronym
PIVAD
Official Title
Right Ventricular Function After Withdrawal of Phosphodiesterase-5 Inhibitors in Left Ventricular Assist Device Recipients
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
October 15, 2019 (Actual)
Primary Completion Date
February 26, 2021 (Actual)
Study Completion Date
March 15, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital, Essen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Phosphodiesterase Inhibitor Adverse Reaction, Right-Sided Heart Failure
Keywords
Left ventricular assist device, postoperative right heart failure

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
withdrawal of a pharmacologic therapy in pre-treated patients without control group
Masking
None (Open Label)
Allocation
N/A
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Phosphodiesterase-5 inhibitor withdrawal
Arm Type
Experimental
Arm Description
In this single arm pretreatment with an oral phosphodiesterase-5 inhibitor will be discontinued
Intervention Type
Other
Intervention Name(s)
withdrawal of oral medication (phosphodiesterase-5 inhibitor) in pretreated patients
Intervention Description
discontinuation of the oral medication with a phosphodiesterase-5 inhibitor
Primary Outcome Measure Information:
Title
Change from baseline in right ventricular global longitudinal strain
Description
Change in right ventricular function from baseline as assessed by global longitudinal strain of the right ventricle on transthoracic echocardiography
Time Frame
4 weeks after discontinuation of phosphodiesterase-5 inhibitors
Secondary Outcome Measure Information:
Title
Change from baseline in peak oxygen uptake rate
Description
Change from baseline in functional status as estimated by peak oxygen uptake rate in cardiopulmonary exercise testing
Time Frame
4 weeks after discontinuation of phosphodiesterase-5 inhibitors
Title
Change from baseline in 6-minute walking distance
Description
Change from baseline in walking distance assessed by 6-minute walking test
Time Frame
4 weeks after discontinuation of phosphodiesterase-5 inhibitors
Title
Change from baseline in the total score of quality of life calculated with the Kansas City Cardiomyopathy Questionnaire
Description
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)
Time Frame
4 weeks after discontinuation of phosphodiesterase-5 inhibitors

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria Papathanasiou, MD
Organizational Affiliation
University Hospital, Essen
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Essen
City
Essen
State/Province
NRW
ZIP/Postal Code
45122
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
15620942
Citation
Trachte AL, Lobato EB, Urdaneta F, Hess PJ, Klodell CT, Martin TD, Staples ED, Beaver TM. Oral sildenafil reduces pulmonary hypertension after cardiac surgery. Ann Thorac Surg. 2005 Jan;79(1):194-7; discussion 194-7. doi: 10.1016/j.athoracsur.2004.06.086.
Results Reference
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PubMed Identifier
20132950
Citation
Kormos RL, Teuteberg JJ, Pagani FD, Russell SD, John R, Miller LW, Massey T, Milano CA, Moazami N, Sundareswaran KS, Farrar DJ; HeartMate II Clinical Investigators. Right ventricular failure in patients with the HeartMate II continuous-flow left ventricular assist device: incidence, risk factors, and effect on outcomes. J Thorac Cardiovasc Surg. 2010 May;139(5):1316-24. doi: 10.1016/j.jtcvs.2009.11.020. Epub 2010 Feb 4.
Results Reference
background
PubMed Identifier
24689700
Citation
Hamdan R, Mansour H, Nassar P, Saab M. Prevention of right heart failure after left ventricular assist device implantation by phosphodiesterase 5 inhibitor. Artif Organs. 2014 Nov;38(11):963-7. doi: 10.1111/aor.12277. Epub 2014 Apr 2.
Results Reference
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PubMed Identifier
26043796
Citation
Baker WL, Radojevic J, Gluck JA. Systematic Review of Phosphodiesterase-5 Inhibitor Use in Right Ventricular Failure Following Left Ventricular Assist Device Implantation. Artif Organs. 2016 Feb;40(2):123-8. doi: 10.1111/aor.12518. Epub 2015 Jun 4.
Results Reference
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PubMed Identifier
17184632
Citation
Klodell CT Jr, Morey TE, Lobato EB, Aranda JM Jr, Staples ED, Schofield RS, Hess PJ, Martin TD, Beaver TM. Effect of sildenafil on pulmonary artery pressure, systemic pressure, and nitric oxide utilization in patients with left ventricular assist devices. Ann Thorac Surg. 2007 Jan;83(1):68-71; discussion 71. doi: 10.1016/j.athoracsur.2006.08.051.
Results Reference
background
PubMed Identifier
19808294
Citation
Tedford RJ, Hemnes AR, Russell SD, Wittstein IS, Mahmud M, Zaiman AL, Mathai SC, Thiemann DR, Hassoun PM, Girgis RE, Orens JB, Shah AS, Yuh D, Conte JV, Champion HC. PDE5A inhibitor treatment of persistent pulmonary hypertension after mechanical circulatory support. Circ Heart Fail. 2008 Nov;1(4):213-9. doi: 10.1161/CIRCHEARTFAILURE.108.796789.
Results Reference
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PubMed Identifier
23352391
Citation
Feldman D, Pamboukian SV, Teuteberg JJ, Birks E, Lietz K, Moore SA, Morgan JA, Arabia F, Bauman ME, Buchholz HW, Deng M, Dickstein ML, El-Banayosy A, Elliot T, Goldstein DJ, Grady KL, Jones K, Hryniewicz K, John R, Kaan A, Kusne S, Loebe M, Massicotte MP, Moazami N, Mohacsi P, Mooney M, Nelson T, Pagani F, Perry W, Potapov EV, Eduardo Rame J, Russell SD, Sorensen EN, Sun B, Strueber M, Mangi AA, Petty MG, Rogers J; International Society for Heart and Lung Transplantation. The 2013 International Society for Heart and Lung Transplantation Guidelines for mechanical circulatory support: executive summary. J Heart Lung Transplant. 2013 Feb;32(2):157-87. doi: 10.1016/j.healun.2012.09.013. No abstract available.
Results Reference
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Phosphodiesterase-5-inhibitors for Right Heart Failure After Left Ventricular Assist Device Implantation

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