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

NCT04117659 | Completed

• 1 other identifier: 177923
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Phosphodiesterase Inhibitor Adverse Reaction; Right-Sided Heart Failure

Keywords

Left ventricular assist device; postoperative right heart failure

Outcome Measures

Primary Outcomes (1)

• 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

  4 weeks after discontinuation of phosphodiesterase-5 inhibitors

Secondary Outcomes (3)

• Change from baseline in peak oxygen uptake rate

  4 weeks after discontinuation of phosphodiesterase-5 inhibitors

• Change from baseline in 6-minute walking distance

  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

  4 weeks after discontinuation of phosphodiesterase-5 inhibitors

Study Arms (1)

Phosphodiesterase-5 inhibitor withdrawal

EXPERIMENTAL

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

Interventions

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

discontinuation of the oral medication with a phosphodiesterase-5 inhibitor

Phosphodiesterase-5 inhibitor withdrawal

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>18 y.o.
• clinically stable, ambulatory heart failure patients on left ventricular assist device support
• uninterrupted therapy with an oral phosphodiesterase-5 inhibitor initiated during the early postoperativ period due to right heart failure

You may not qualify if:

• unable to provide written informed consent
• refusal to provide written informed consent

Sponsors & Collaborators

• University Hospital, Essen: lead

Study Sites (1)

University Hospital Essen

Essen, North Rhine-Westphalia, 45122, Germany

Location

Related Publications (7)

• 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.

  PMID: 15620942 BACKGROUND

• 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.

  PMID: 20132950 BACKGROUND

• 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.

  PMID: 24689700 BACKGROUND

• 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.

  PMID: 26043796 BACKGROUND

• 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.

  PMID: 17184632 BACKGROUND

• 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.

  PMID: 19808294 BACKGROUND

• 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.

  PMID: 23352391 BACKGROUND

MeSH Terms

Conditions

Heart Failure

Interventions

Phosphodiesterase 5 Inhibitors

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Phosphodiesterase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Maria Papathanasiou, MD

  University Hospital, Essen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Cardiologist

Model Details: withdrawal of a pharmacologic therapy in pre-treated patients without control group

Study Record Dates

• First Submitted: August 22, 2019
• First Posted: October 7, 2019
• Study Start: October 15, 2019
• Primary Completion: February 26, 2021
• Study Completion: March 15, 2021
• Last Updated: June 22, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)