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

Right-Sided Heart Failure Clinical Trial

— PIVAD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04117659
• Other study ID #: 177923
• Status: Completed
• Phase: N/A
• Start date: October 15, 2019
• Est. completion date: March 15, 2021

Study information

• Verified date: June 2022
• Source: University Hospital, Essen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: March 15, 2021
• Est. primary completion date: February 26, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure
• Phosphodiesterase Inhibitor Adverse Reaction
• Right-Sided Heart Failure

Intervention

Other:
• withdrawal of oral medication (phosphodiesterase-5 inhibitor) in pretreated patients
discontinuation of the oral medication with a phosphodiesterase-5 inhibitor

Locations

Country	Name	City	State
Germany	University Hospital Essen	Essen	NRW

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Essen

Country where clinical trial is conducted

Germany, 

References & Publications (7)

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. Review. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	4 weeks after discontinuation of phosphodiesterase-5 inhibitors
Secondary	Change from baseline in 6-minute walking distance	Change from baseline in walking distance assessed by 6-minute walking test	4 weeks after discontinuation of phosphodiesterase-5 inhibitors
Secondary	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)	4 weeks after discontinuation of phosphodiesterase-5 inhibitors