Phosphodiesterase Inhibitor Adverse ReactionPIVADNCT04117659
Phosphodiesterase-5-inhibitors for Right Heart Failure After Left Ventricular Assist Device Implantation
A study testing withdrawal of oral medication (phosphodiesterase-5 inhibitor) in pretreated patients in people with Phosphodiesterase Inhibitor Adverse Reaction and Right-Sided Heart Failure, run by University Hospital, Essen at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Phosphodiesterase Inhibitor Adverse Reaction, Right-Sided Heart Failure
- What is being tested?
- withdrawal of oral medication (phosphodiesterase-5 inhibitor) in pretreated patients
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteGermany
- Study dates
- 15 Oct 2019to 15 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- unable to provide written informed consent
- refusal to provide written informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- withdrawal of oral medication (phosphodiesterase-5 inhibitor) in pretreated patients
- Keywords
- Left ventricular assist device, postoperative right heart failure
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
withdrawal of oral medication (phosphodiesterase-5 inhibitor) in pretreated patientsOther
discontinuation of the oral medication with a phosphodiesterase-5 inhibitor
| Study group | Role | What they receive |
|---|---|---|
| Phosphodiesterase-5 inhibitor withdrawal | Experimental | In this single arm pretreatment with an oral phosphodiesterase-5 inhibitor will be discontinued Receives: Other: withdrawal of oral medication (phosphodiesterase-5 inhibitor) in pretreated patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 4 weeks after discontinuation of phosphodiesterase-5 inhibitors
Secondary outcomes (3)
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
Measured: 4 weeks after discontinuation of phosphodiesterase-5 inhibitors
Change from baseline in 6-minute walking distance
Change from baseline in walking distance assessed by 6-minute walking test
Measured: 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
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)
Measured: 4 weeks after discontinuation of phosphodiesterase-5 inhibitors
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2019
- Study start15 Oct 2019
- Primary completion26 Feb 2021
- Study completion15 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Phosphodiesterase Inhibitor Adverse ReactionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- withdrawal of a pharmacologic therapy in pre-treated patients without control group
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Essen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria Papathanasiou, University Hospital, Essen
- Investigators
- Maria Papathanasiou, MD, Principal investigator, University Hospital, Essen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04117659
- Sponsor's protocol ID
- 177923
- Acronym
- PIVAD
- Status last verified
- Jun 2022
- First submitted
- 22 Aug 2019
- Last updated
- 22 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 15620942Kormos 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.
PubMed 20132950Hamdan 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.
PubMed 24689700Baker 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.
PubMed 26043796Klodell 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.
PubMed 17184632Tedford 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.
PubMed 19808294Feldman 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.
PubMed 23352391
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Right Ventricular Function After Withdrawal of Phosphodiesterase-5 Inhibitors in Left Ventricular Assist Device Recipients
- ClinicalTrials.gov ID
- NCT04117659
- Acronym / sponsor ID
- PIVAD / 177923
- Keywords
- Left ventricular assist device, postoperative right heart failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University Hospital, EssenUniversity, hospital or other
- Study start
- 15 Oct 2019 (actual)
- Primary completion
- 26 Feb 2021 (actual)
- Study completion
- 15 Mar 2021 (actual)
- First posted
- 7 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- withdrawal of a pharmacologic therapy in pre-treated patients without control group
| Arm | Type | Receives |
|---|---|---|
| Phosphodiesterase-5 inhibitor withdrawal | Experimental | Other: withdrawal of oral medication (phosphodiesterase-5 inhibitor) in pretreated patientsIn this single arm pretreatment with an oral phosphodiesterase-5 inhibitor will be discontinued |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- unable to provide written informed consent
- refusal to provide written informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| withdrawal of oral medication (phosphodiesterase-5 inhibitor) in pretreated patientsdiscontinuation of the oral medication with a phosphodiesterase-5 inhibitor | Other | Phosphodiesterase-5 inhibitor withdrawal |
Primary outcome
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
3 secondary outcomes
Change from baseline in peak oxygen uptake rate
Time frame: 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 the total score of quality of life calculated with the Kansas City Cardiomyopathy Questionnaire
Time frame: 4 weeks after discontinuation of phosphodiesterase-5 inhibitors
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2022.
- Background: PubMed 15620942Trachte 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.
- Background: PubMed 20132950Kormos 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.
- Background: PubMed 24689700Hamdan 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.
- Background: PubMed 26043796Baker 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.
- Background: PubMed 17184632Klodell 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.
- Background: PubMed 19808294Tedford 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.
- Background: PubMed 23352391Feldman 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria Papathanasiou, MD principal investigator
University Hospital, Essen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing withdrawal of oral medication (phosphodiesterase-5 inhibitor) in pretreated patients in people with Phosphodiesterase Inhibitor Adverse Reaction and Right-Sided Heart Failure, run by University Hospital, Essen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in right ventricular global longitudinal strain (time frame: 4 weeks after discontinuation of phosphodiesterase-5 inhibitors). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04117659, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2022.