Pulmonary vasodilation by sildenafil in acute intermediate-high risk pulmonary embolism: a randomized explorative trial
Abstract Background To investigate if acute pulmonary vasodilation by sildenafil improves right ventricular function in patients with acute intermediate-high risk pulmonary embolism (PE). Methods Single center, explorative trial. Patients with PE were randomized to a single oral dose of sildenafil 5...
| Main Authors: | , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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BMC
2021-02-01
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| Series: | BMC Pulmonary Medicine |
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| Online Access: | https://doi.org/10.1186/s12890-021-01440-7 |
| _version_ | 1818557962828906496 |
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| author | Asger Andersen Farhad Waziri Jacob Gammelgaard Schultz Sarah Holmboe Søren Warberg Becker Tage Jensen Hanne Maare Søndergaard Karen Kaae Dodt Ole May Ulrik Markus Mortensen Won Yong Kim Søren Mellemkjær Jens Erik Nielsen-Kudsk |
| author_facet | Asger Andersen Farhad Waziri Jacob Gammelgaard Schultz Sarah Holmboe Søren Warberg Becker Tage Jensen Hanne Maare Søndergaard Karen Kaae Dodt Ole May Ulrik Markus Mortensen Won Yong Kim Søren Mellemkjær Jens Erik Nielsen-Kudsk |
| author_sort | Asger Andersen |
| collection | DOAJ |
| description | Abstract Background To investigate if acute pulmonary vasodilation by sildenafil improves right ventricular function in patients with acute intermediate-high risk pulmonary embolism (PE). Methods Single center, explorative trial. Patients with PE were randomized to a single oral dose of sildenafil 50 mg (n = 10) or placebo (n = 10) as add-on to conventional therapy. The time from hospital admission to study inclusion was 2.3 ± 0.7 days. Right ventricular function was evaluated immediately before and shortly after (0.5–1.5 h) randomization by right heart catheterization (RHC), trans-thoracic echocardiography (TTE), and cardiac magnetic resonance (CMR). The primary efficacy endpoint was cardiac index measured by CMR. Results Patients had acute intermediate-high risk PE verified by computed tomography pulmonary angiography, systolic blood pressure of 135 ± 18 (mean ± SD) mmHg, increased right ventricular/left ventricular ratio 1.1 ± 0.09 and increased troponin T 167 ± 144 ng/L. Sildenafil treatment did not improve cardiac index compared to baseline (0.02 ± 0.36 l/min/m2, p = 0.89) and neither did placebo (0.00 ± 0.34 l/min/m2, p = 0.97). Sildenafil lowered mean arterial blood pressure (− 19 ± 10 mmHg, p < 0.001) which was not observed in the placebo group (0 ± 9 mmHg, p = 0.97). Conclusion A single oral dose of sildenafil 50 mg did not improve cardiac index but lowered systemic blood pressure in patients with acute intermediate-high risk PE. The time from PE to intervention, a small patient sample size and low pulmonary vascular resistance are limitations of this study that should be considered when interpreting the results. Trial Registration: The trial was retrospectively registered at www.clinicaltrials.gov (NCT04283240) February 2nd 2020, https://clinicaltrials.gov/ct2/show/NCT04283240?term=NCT04283240&draw=2&rank=1 . |
| first_indexed | 2024-12-14T00:06:35Z |
| format | Article |
| id | doaj.art-7aeab1891a4d45ebb6045c7b25fae4e7 |
| institution | Directory Open Access Journal |
| issn | 1471-2466 |
| language | English |
| last_indexed | 2024-12-14T00:06:35Z |
| publishDate | 2021-02-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Pulmonary Medicine |
| spelling | doaj.art-7aeab1891a4d45ebb6045c7b25fae4e72022-12-21T23:26:00ZengBMCBMC Pulmonary Medicine1471-24662021-02-012111810.1186/s12890-021-01440-7Pulmonary vasodilation by sildenafil in acute intermediate-high risk pulmonary embolism: a randomized explorative trialAsger Andersen0Farhad Waziri1Jacob Gammelgaard Schultz2Sarah Holmboe3Søren Warberg Becker4Tage Jensen5Hanne Maare Søndergaard6Karen Kaae Dodt7Ole May8Ulrik Markus Mortensen9Won Yong Kim10Søren Mellemkjær11Jens Erik Nielsen-Kudsk12Department of Cardiology, Aarhus University HospitalDepartment of Cardiology, Aarhus University HospitalDepartment of Cardiology, Aarhus University HospitalDepartment of Cardiology, Aarhus University HospitalDiagnostic Centre, Region Hospital of SilkeborgDepartment of Internal Medicine, Region Hospital of RandersDepartment of Cardiology, Region Hospital of ViborgDepartment of Internal Medicine, Region Hospital of HorsensDepartment of Internal Medicine, Region Hospital of HerningDepartment of Cardiology, Aarhus University HospitalDepartment of Cardiology, Aarhus University HospitalDepartment of Cardiology, Aarhus University HospitalDepartment of Cardiology, Aarhus University HospitalAbstract Background To investigate if acute pulmonary vasodilation by sildenafil improves right ventricular function in patients with acute intermediate-high risk pulmonary embolism (PE). Methods Single center, explorative trial. Patients with PE were randomized to a single oral dose of sildenafil 50 mg (n = 10) or placebo (n = 10) as add-on to conventional therapy. The time from hospital admission to study inclusion was 2.3 ± 0.7 days. Right ventricular function was evaluated immediately before and shortly after (0.5–1.5 h) randomization by right heart catheterization (RHC), trans-thoracic echocardiography (TTE), and cardiac magnetic resonance (CMR). The primary efficacy endpoint was cardiac index measured by CMR. Results Patients had acute intermediate-high risk PE verified by computed tomography pulmonary angiography, systolic blood pressure of 135 ± 18 (mean ± SD) mmHg, increased right ventricular/left ventricular ratio 1.1 ± 0.09 and increased troponin T 167 ± 144 ng/L. Sildenafil treatment did not improve cardiac index compared to baseline (0.02 ± 0.36 l/min/m2, p = 0.89) and neither did placebo (0.00 ± 0.34 l/min/m2, p = 0.97). Sildenafil lowered mean arterial blood pressure (− 19 ± 10 mmHg, p < 0.001) which was not observed in the placebo group (0 ± 9 mmHg, p = 0.97). Conclusion A single oral dose of sildenafil 50 mg did not improve cardiac index but lowered systemic blood pressure in patients with acute intermediate-high risk PE. The time from PE to intervention, a small patient sample size and low pulmonary vascular resistance are limitations of this study that should be considered when interpreting the results. Trial Registration: The trial was retrospectively registered at www.clinicaltrials.gov (NCT04283240) February 2nd 2020, https://clinicaltrials.gov/ct2/show/NCT04283240?term=NCT04283240&draw=2&rank=1 .https://doi.org/10.1186/s12890-021-01440-7Pulmonary embolismSildenafilPDE5 inhibitionPulmonary vasodilation |
| spellingShingle | Asger Andersen Farhad Waziri Jacob Gammelgaard Schultz Sarah Holmboe Søren Warberg Becker Tage Jensen Hanne Maare Søndergaard Karen Kaae Dodt Ole May Ulrik Markus Mortensen Won Yong Kim Søren Mellemkjær Jens Erik Nielsen-Kudsk Pulmonary vasodilation by sildenafil in acute intermediate-high risk pulmonary embolism: a randomized explorative trial BMC Pulmonary Medicine Pulmonary embolism Sildenafil PDE5 inhibition Pulmonary vasodilation |
| title | Pulmonary vasodilation by sildenafil in acute intermediate-high risk pulmonary embolism: a randomized explorative trial |
| title_full | Pulmonary vasodilation by sildenafil in acute intermediate-high risk pulmonary embolism: a randomized explorative trial |
| title_fullStr | Pulmonary vasodilation by sildenafil in acute intermediate-high risk pulmonary embolism: a randomized explorative trial |
| title_full_unstemmed | Pulmonary vasodilation by sildenafil in acute intermediate-high risk pulmonary embolism: a randomized explorative trial |
| title_short | Pulmonary vasodilation by sildenafil in acute intermediate-high risk pulmonary embolism: a randomized explorative trial |
| title_sort | pulmonary vasodilation by sildenafil in acute intermediate high risk pulmonary embolism a randomized explorative trial |
| topic | Pulmonary embolism Sildenafil PDE5 inhibition Pulmonary vasodilation |
| url | https://doi.org/10.1186/s12890-021-01440-7 |
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