Vascular DiseasesEarly Phase 1NCT06510322
Sildenafil to Reduce Vascular Remodeling During Left Ventricular Assist Device Support
A Early Phase 1 study testing Sildenafil in people with Vascular Diseases, run by Montefiore Medical Center at 1 site in United States.
Trial summary
Contemporary left ventricular assist device (LVAD) therapy improves survival during advanced heart failure but vascular aging develops rapidly leading to major adverse events including stroke and bleeding in nearly half of patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vascular Diseases
- What is being tested?
- Sildenafil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Mar 2025to Dec 2029
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
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
- Over 18 years of age
- Supported by a durable LVAD or planned to undergo placement of a durable LVAD
- Be able to give informed consent
Who cannot join
- History of pre-existing aortic valve prosthesis or an aortic graft
- Allergy to sildenafil
- Taking any nitric oxide (NO) donor medications
- History of complete carotid occlusion
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Lorenzo D'Angelo, MD contact
United States1 site, 1 recruiting
- Recruiting
Montefiore Medical Center
The Bronx, New York, 10461
About this study
Contemporary left ventricular assist device (LVAD) therapy improves survival during advanced heart failure but vascular aging develops rapidly leading to major adverse events including stroke and bleeding in nearly half of patients. In this study, the study team aims to investigate whether sildenafil pharmacotherapy, which has anti-fibrotic effects, can reduce vascular aging during LVAD support. An aim of this study is to compare changes in small blood vessels in the gastrointestinal tract between participants receiving sildenafil or placebo. Video capsule endoscopy (VCE) will be used to assess these changes in small blood vessels.
Read the detailed description
Over 6.5 million individuals in the United States suffer from heart failure (HF), with the burden of this disease expected to grow over the next decade. Approximately 300,000 of these patients have advanced HF and may benefit from durable left ventricular assist device (LVAD) therapy, which can improve outcomes during advanced HF. However, despite advancements in device design that have increased survival rates, large registries of real- world cases reveal that nearly half of patients experience severe vascular adverse events, including stroke and bleeding, during prolonged contemporary LVAD support. This elevated adverse-event rate remains a major barrier to safely expanding the use and durability of LVAD therapy. Vascular remodeling or aging of the large and small blood vessels is known to promote stroke and bleeding within the general population. Critically, such remodeling is rapidly accelerated under conditions of reduced pulsatility produced by LVADs, evidenced by large vessel stiffening and fibrosis, small vessel angiodysplasia, and endothelial dysfunction. Phosphodiesterase-5 inhibitors (PDE5i), such as sildenafil, are prescribed to select LVAD patients with pulmonary hypertension and right heart failure. However, given that these agents enhance nitric oxide-cGMP signaling in platelets and vascular smooth muscle cells, leading to anti-thrombotic and anti-fibrotic effects, they may also reduce vascular remodeling and related adverse events. Here, based on preliminary findings, a double-blind, randomized, placebo-controlled trial will be conducted to determine the effects of chronic sildenafil administration on vascular remodeling during LVAD support.
- Conditions
- Vascular Diseases
- Being tested
- Sildenafil, Placebo
- Medical subject headings
- Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SildenafilDrug
Orally administered phosphodiesterase-5 (PDE-5) inhibitor, which enhances nitric oxide signaling in platelets and blood vessels.
PlaceboOther
Matched capsule not containing any medication
| Study group | Role | What they receive |
|---|---|---|
| Sildenafil | Active comparator | Participants in this arm will receive sildenafil 20mg every 8 hours for 1 week and then dose will be up titrated to 40mg every 8 hours for the duration of the study period. Receives: Drug: Sildenafil |
| Placebo | Placebo comparator | Participants in this arm will receive matching placebo, which serves as a negative control to understand changes in small and large blood vessels. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Aortic Pulse Wave Velocity
Pulse wave velocity (PWV) will be measured by vascular ultrasound. PWV will be calculated by dividing the distance between the carotid and femoral artery waveform acquisition sites (in meters) by the carotid-femoral transit time (change in time, in seconds). Change in group mean PWV from baseline will be summarized. Increases in PWV can be an indicator of vascular fibrosis and are associated with increased risk of cardiovascular comorbidities.
Measured: From Baseline to 180 days
Change in Gastrointestinal Angiodysplasia (GIAD) Foci
Microvascular angiodysplasia will be assessed by video capsule endoscopy (VCE). VCE is a minimally invasive technique used to identify gastrointestinal lesions and diagnose GIAD. Change in the group mean number of GIAD foci/lesions per patient from baseline to 180 days will be determined.
GIAD formation will only be assessed at baseline and at 180 days unless the patient(s) experiences an episode of gastrointestinal bleeding prior to 180 days.
Measured: From Baseline to 180 days
Change in Vascular Reactivity Index
Endothelial function will be determined by the finger vascular reactivity index (VRI) during LVAD support. VRI will be assessed by a non-invasive method using the Endothelix device. VRI is determined by measuring fingertip temperature change before and after cuff deflation. Change in group median VRI values from baseline will be summarized. Positive changes from baseline are associated with improved endothelial function.
Measured: From Baseline to 180 days
Secondary outcomes (2)
Change in Urinary Protein to Creatinine Ratio (PCR)
Urine samples will be assessed to determine the protein to creatinine ratio. Urinary PCR is calculated by dividing the concentration of protein (mg/dL) in the urine sample by the creatinine concentration (mg/dL). Change in group mean urinary protein to creatine ratios from baseline will be summarized. Elevated ratios of protein to creatinine are associated with increased risk of renal disease and microvascular dysfunction.
Measured: From Baseline to 180 days and, as available, 12, 18, and 24 months
Platelet Gene Expression
Platelet samples will be assessed for changes in gene expression using RNA sequencing analysis. Platelets will be isolated from whole blood samples collected at baseline, 3 months, and 6 months from participants in each group. Equal number of isolated platelets will be lysed in Trizol and DNAse treated total RNA will be isolated. RNA sequencing will be performed using HiSeq 50 Cycle Single Read Sequencing after library preparation. Differentially expressed genes (DEGs) will be ranked by their expression change between groups. DEGs with > 1.5-fold change in expression after LVAD at a sequence depth of >30 million reads per sample will be ranked by study arm.
Measured: Baseline, 3 months, and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2024
- Study start12 Mar 2025
- Primary completionDec 2029 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for Vascular DiseasesStudies of the same condition, open and under way.
- More trials run by Montefiore Medical CenterThe sponsor's other registered studies.
- 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Montefiore Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Omar Saeed, MD, Principal investigator, Montefiore Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06510322
- Sponsor's protocol ID
- 2024-16098
- Other IDs
- 1R01HL172972
- Status last verified
- Jan 2026
- First submitted
- 15 Jul 2024
- Last updated
- 23 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Roger VL. Epidemiology of Heart Failure: A Contemporary Perspective. Circ Res. 2021 May 14;128(10):1421-1434. doi: 10.1161/CIRCRESAHA.121.318172. Epub 2021 May 13.
PubMed 33983838Molina EJ, Shah P, Kiernan MS, Cornwell WK 3rd, Copeland H, Takeda K, Fernandez FG, Badhwar V, Habib RH, Jacobs JP, Koehl D, Kirklin JK, Pagani FD, Cowger JA. The Society of Thoracic Surgeons Intermacs 2020 Annual Report. Ann Thorac Surg. 2021 Mar;111(3):778-792. doi: 10.1016/j.athoracsur.2020.12.038. Epub 2021 Jan 16.
PubMed 33465365Colombo PC, Mehra MR, Goldstein DJ, Estep JD, Salerno C, Jorde UP, Cowger JA, Cleveland JC Jr, Uriel N, Sayer G, Skipper ER, Downey FX, Ono M, Hooker R Jr, Anyanwu AC, Givertz MM, Mahr C, Topuria I, Somo SI, Crandall DL, Horstmanshof DA. Comprehensive Analysis of Stroke in the Long-Term Cohort of the MOMENTUM 3 Study. Circulation. 2019 Jan 8;139(2):155-168. doi: 10.1161/CIRCULATIONAHA.118.037231.
PubMed 30586698Yuzefpolskaya M, Schroeder SE, Houston BA, Robinson MR, Gosev I, Reyentovich A, Koehl D, Cantor R, Jorde UP, Kirklin JK, Pagani FD, D'Alessandro DA. The Society of Thoracic Surgeons Intermacs 2022 Annual Report: Focus on the 2018 Heart Transplant Allocation System. Ann Thorac Surg. 2023 Feb;115(2):311-327. doi: 10.1016/j.athoracsur.2022.11.023. Epub 2022 Dec 1.
PubMed 36462544Jorde UP, Saeed O, Koehl D, Morris AA, Wood KL, Meyer DM, Cantor R, Jacobs JP, Kirklin JK, Pagani FD, Vega JD. The Society of Thoracic Surgeons Intermacs 2023 Annual Report: Focus on Magnetically Levitated Devices. Ann Thorac Surg. 2024 Jan;117(1):33-44. doi: 10.1016/j.athoracsur.2023.11.004. Epub 2023 Nov 8.
PubMed 37944655Schmitto JD, Shaw S, Garbade J, Gustafsson F, Morshuis M, Zimpfer D, Lavee J, Pya Y, Berchtold-Herz M, Wang A, Gazzola C, Potapov E, Saeed D. Fully magnetically centrifugal left ventricular assist device and long-term outcomes: the ELEVATE registry. Eur Heart J. 2024 Feb 21;45(8):613-625. doi: 10.1093/eurheartj/ehad658.
PubMed 38036414Demirozu ZT, Radovancevic R, Hochman LF, Gregoric ID, Letsou GV, Kar B, Bogaev RC, Frazier OH. Arteriovenous malformation and gastrointestinal bleeding in patients with the HeartMate II left ventricular assist device. J Heart Lung Transplant. 2011 Aug;30(8):849-53. doi: 10.1016/j.healun.2011.03.008. Epub 2011 Apr 29.
PubMed 21530318Mattace-Raso FU, van der Cammen TJ, Hofman A, van Popele NM, Bos ML, Schalekamp MA, Asmar R, Reneman RS, Hoeks AP, Breteler MM, Witteman JC. Arterial stiffness and risk of coronary heart disease and stroke: the Rotterdam Study. Circulation. 2006 Feb 7;113(5):657-63. doi: 10.1161/CIRCULATIONAHA.105.555235.
PubMed 16461838Zieman SJ, Melenovsky V, Kass DA. Mechanisms, pathophysiology, and therapy of arterial stiffness. Arterioscler Thromb Vasc Biol. 2005 May;25(5):932-43. doi: 10.1161/01.ATV.0000160548.78317.29. Epub 2005 Feb 24.
PubMed 15731494Ambardekar AV, Hunter KS, Babu AN, Tuder RM, Dodson RB, Lindenfeld J. Changes in Aortic Wall Structure, Composition, and Stiffness With Continuous-Flow Left Ventricular Assist Devices: A Pilot Study. Circ Heart Fail. 2015 Sep;8(5):944-52. doi: 10.1161/CIRCHEARTFAILURE.114.001955. Epub 2015 Jul 1.
PubMed 26136459Ambardekar AV, Stratton MS, Dobrinskikh E, Hunter KS, Tatman PD, Lemieux ME, Cleveland JC, Tuder RM, Weiser-Evans MCM, Moulton KS, McKinsey TA. Matrix-Degrading Enzyme Expression and Aortic Fibrosis During Continuous-Flow Left Ventricular Mechanical Support. J Am Coll Cardiol. 2021 Nov 2;78(18):1782-1795. doi: 10.1016/j.jacc.2021.08.047.
PubMed 34711337Templeton DL, John R, Painter P, Kelly AS, Dengel DR. Effects of the left ventricular assist device on the compliance and distensibility of the carotid artery. Heart Vessels. 2013 May;28(3):377-84. doi: 10.1007/s00380-012-0271-4. Epub 2012 Aug 9.
PubMed 22875409Kiyatkin M, Stöhr E, Zuver A, Gaudig A, Yuzefpolskaya M, Colombo P and Willey J. Carotid artery flow and its assciation with stroke during left ventricular assist device support. Critical Care Medicine. 2019;47:53.
Hackam DG, Spence JD. Antiplatelet Therapy in Ischemic Stroke and Transient Ischemic Attack. Stroke. 2019 Mar;50(3):773-778. doi: 10.1161/STROKEAHA.118.023954. No abstract available.
PubMed 30626286Lebas H, Yahiaoui K, Martos R, Boulaftali Y. Platelets Are at the Nexus of Vascular Diseases. Front Cardiovasc Med. 2019 Sep 11;6:132. doi: 10.3389/fcvm.2019.00132. eCollection 2019.
PubMed 31572732
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sildenafil to Reduce Vascular Remodeling During Left Ventricular Assist Device Support
- ClinicalTrials.gov ID
- NCT06510322
- Acronym / sponsor ID
- 2024-16098
- Conditions
- Vascular Diseases
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Montefiore Medical CenterUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 12 Mar 2025 (actual)
- Primary completion
- Dec 2029 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 19 Jul 2024 (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.
Contemporary left ventricular assist device (LVAD) therapy improves survival during advanced heart failure but vascular aging develops rapidly leading to major adverse events including stroke and bleeding in nearly half of patients. In this study, the study team aims to investigate whether sildenafil pharmacotherapy, which has anti-fibrotic effects, can reduce vascular aging during LVAD support. An aim of this study is to compare changes in small blood vessels in the gastrointestinal tract between participants receiving sildenafil or placebo. Video capsule endoscopy (VCE) will be used to assess these changes in small blood vessels.
Detailed description
Over 6.5 million individuals in the United States suffer from heart failure (HF), with the burden of this disease expected to grow over the next decade. Approximately 300,000 of these patients have advanced HF and may benefit from durable left ventricular assist device (LVAD) therapy, which can improve outcomes during advanced HF. However, despite advancements in device design that have increased survival rates, large registries of real- world cases reveal that nearly half of patients experience severe vascular adverse events, including stroke and bleeding, during prolonged contemporary LVAD support. This elevated adverse-event rate remains a major barrier to safely expanding the use and durability of LVAD therapy. Vascular remodeling or aging of the large and small blood vessels is known to promote stroke and bleeding within the general population. Critically, such remodeling is rapidly accelerated under conditions of reduced pulsatility produced by LVADs, evidenced by large vessel stiffening and fibrosis, small vessel angiodysplasia, and endothelial dysfunction. Phosphodiesterase-5 inhibitors (PDE5i), such as sildenafil, are prescribed to select LVAD patients with pulmonary hypertension and right heart failure. However, given that these agents enhance nitric oxide-cGMP signaling in platelets and vascular smooth muscle cells, leading to anti-thrombotic and anti-fibrotic effects, they may also reduce vascular remodeling and related adverse events. Here, based on preliminary findings, a double-blind, randomized, placebo-controlled trial will be conducted to determine the effects of chronic sildenafil administration on vascular remodeling during LVAD support.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sildenafil | Active comparator | Drug: SildenafilParticipants in this arm will receive sildenafil 20mg every 8 hours for 1 week and then dose will be up titrated to 40mg every 8 hours for the duration of the study period. |
| Placebo | Placebo comparator | Other: PlaceboParticipants in this arm will receive matching placebo, which serves as a negative control to understand changes in small and large blood vessels. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Over 18 years of age
- Supported by a durable LVAD or planned to undergo placement of a durable LVAD
- Be able to give informed consent
Key exclusion criteria (4 listed)
- History of pre-existing aortic valve prosthesis or an aortic graft
- Allergy to sildenafil
- Taking any nitric oxide (NO) donor medications
- History of complete carotid occlusion
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 |
|---|---|---|
| SildenafilOrally administered phosphodiesterase-5 (PDE-5) inhibitor, which enhances nitric oxide signaling in platelets and blood vessels. | Drug | Sildenafil |
| PlaceboMatched capsule not containing any medication | Other | Placebo |
Primary outcome
Change in Aortic Pulse Wave Velocity
Time frame: From Baseline to 180 days
Pulse wave velocity (PWV) will be measured by vascular ultrasound. PWV will be calculated by dividing the distance between the carotid and femoral artery waveform acquisition sites (in meters) by the carotid-femoral transit time (change in time, in seconds). Change in group mean PWV from baseline will be summarized. Increases in PWV can be an indicator of vascular fibrosis and are associated with increased risk of cardiovascular comorbidities.
Change in Gastrointestinal Angiodysplasia (GIAD) Foci
Time frame: From Baseline to 180 days
Microvascular angiodysplasia will be assessed by video capsule endoscopy (VCE). VCE is a minimally invasive technique used to identify gastrointestinal lesions and diagnose GIAD. Change in the group mean number of GIAD foci/lesions per patient from baseline to 180 days will be determined. GIAD formation will only be assessed at baseline and at 180 days unless the patient(s) experiences an episode of gastrointestinal bleeding prior to 180 days.
Change in Vascular Reactivity Index
Time frame: From Baseline to 180 days
Endothelial function will be determined by the finger vascular reactivity index (VRI) during LVAD support. VRI will be assessed by a non-invasive method using the Endothelix device. VRI is determined by measuring fingertip temperature change before and after cuff deflation. Change in group median VRI values from baseline will be summarized. Positive changes from baseline are associated with improved endothelial function.
2 secondary outcomes
Change in Urinary Protein to Creatinine Ratio (PCR)
Time frame: From Baseline to 180 days and, as available, 12, 18, and 24 months
Platelet Gene Expression
Time frame: Baseline, 3 months, and 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2026.
- Background: PubMed 33983838Roger VL. Epidemiology of Heart Failure: A Contemporary Perspective. Circ Res. 2021 May 14;128(10):1421-1434. doi: 10.1161/CIRCRESAHA.121.318172. Epub 2021 May 13.
- Background: PubMed 33465365Molina EJ, Shah P, Kiernan MS, Cornwell WK 3rd, Copeland H, Takeda K, Fernandez FG, Badhwar V, Habib RH, Jacobs JP, Koehl D, Kirklin JK, Pagani FD, Cowger JA. The Society of Thoracic Surgeons Intermacs 2020 Annual Report. Ann Thorac Surg. 2021 Mar;111(3):778-792. doi: 10.1016/j.athoracsur.2020.12.038. Epub 2021 Jan 16.
- Background: PubMed 30586698Colombo PC, Mehra MR, Goldstein DJ, Estep JD, Salerno C, Jorde UP, Cowger JA, Cleveland JC Jr, Uriel N, Sayer G, Skipper ER, Downey FX, Ono M, Hooker R Jr, Anyanwu AC, Givertz MM, Mahr C, Topuria I, Somo SI, Crandall DL, Horstmanshof DA. Comprehensive Analysis of Stroke in the Long-Term Cohort of the MOMENTUM 3 Study. Circulation. 2019 Jan 8;139(2):155-168. doi: 10.1161/CIRCULATIONAHA.118.037231.
- Background: PubMed 36462544Yuzefpolskaya M, Schroeder SE, Houston BA, Robinson MR, Gosev I, Reyentovich A, Koehl D, Cantor R, Jorde UP, Kirklin JK, Pagani FD, D'Alessandro DA. The Society of Thoracic Surgeons Intermacs 2022 Annual Report: Focus on the 2018 Heart Transplant Allocation System. Ann Thorac Surg. 2023 Feb;115(2):311-327. doi: 10.1016/j.athoracsur.2022.11.023. Epub 2022 Dec 1.
- Background: PubMed 37944655Jorde UP, Saeed O, Koehl D, Morris AA, Wood KL, Meyer DM, Cantor R, Jacobs JP, Kirklin JK, Pagani FD, Vega JD. The Society of Thoracic Surgeons Intermacs 2023 Annual Report: Focus on Magnetically Levitated Devices. Ann Thorac Surg. 2024 Jan;117(1):33-44. doi: 10.1016/j.athoracsur.2023.11.004. Epub 2023 Nov 8.
- Background: PubMed 38036414Schmitto JD, Shaw S, Garbade J, Gustafsson F, Morshuis M, Zimpfer D, Lavee J, Pya Y, Berchtold-Herz M, Wang A, Gazzola C, Potapov E, Saeed D. Fully magnetically centrifugal left ventricular assist device and long-term outcomes: the ELEVATE registry. Eur Heart J. 2024 Feb 21;45(8):613-625. doi: 10.1093/eurheartj/ehad658.
- Background: PubMed 21530318Demirozu ZT, Radovancevic R, Hochman LF, Gregoric ID, Letsou GV, Kar B, Bogaev RC, Frazier OH. Arteriovenous malformation and gastrointestinal bleeding in patients with the HeartMate II left ventricular assist device. J Heart Lung Transplant. 2011 Aug;30(8):849-53. doi: 10.1016/j.healun.2011.03.008. Epub 2011 Apr 29.
- Background: PubMed 16461838Mattace-Raso FU, van der Cammen TJ, Hofman A, van Popele NM, Bos ML, Schalekamp MA, Asmar R, Reneman RS, Hoeks AP, Breteler MM, Witteman JC. Arterial stiffness and risk of coronary heart disease and stroke: the Rotterdam Study. Circulation. 2006 Feb 7;113(5):657-63. doi: 10.1161/CIRCULATIONAHA.105.555235.
- Background: PubMed 15731494Zieman SJ, Melenovsky V, Kass DA. Mechanisms, pathophysiology, and therapy of arterial stiffness. Arterioscler Thromb Vasc Biol. 2005 May;25(5):932-43. doi: 10.1161/01.ATV.0000160548.78317.29. Epub 2005 Feb 24.
- Background: PubMed 26136459Ambardekar AV, Hunter KS, Babu AN, Tuder RM, Dodson RB, Lindenfeld J. Changes in Aortic Wall Structure, Composition, and Stiffness With Continuous-Flow Left Ventricular Assist Devices: A Pilot Study. Circ Heart Fail. 2015 Sep;8(5):944-52. doi: 10.1161/CIRCHEARTFAILURE.114.001955. Epub 2015 Jul 1.
- Background: PubMed 34711337Ambardekar AV, Stratton MS, Dobrinskikh E, Hunter KS, Tatman PD, Lemieux ME, Cleveland JC, Tuder RM, Weiser-Evans MCM, Moulton KS, McKinsey TA. Matrix-Degrading Enzyme Expression and Aortic Fibrosis During Continuous-Flow Left Ventricular Mechanical Support. J Am Coll Cardiol. 2021 Nov 2;78(18):1782-1795. doi: 10.1016/j.jacc.2021.08.047.
- Background: PubMed 22875409Templeton DL, John R, Painter P, Kelly AS, Dengel DR. Effects of the left ventricular assist device on the compliance and distensibility of the carotid artery. Heart Vessels. 2013 May;28(3):377-84. doi: 10.1007/s00380-012-0271-4. Epub 2012 Aug 9.
- Individual participant dataSharing planned: No
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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.
Lorenzo D'Angelo, MD contact
Omar Saeed, MD principal investigator
Montefiore Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Sildenafil in people with Vascular Diseases, run by Montefiore Medical Center at 1 site in United States.
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 3 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 23 Jan 2026. 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 United States. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Omar Saeed, MD (718-920-2626, osaeed@montefiore.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Aortic Pulse Wave Velocity (time frame: From Baseline to 180 days). The study lists 3 primary outcomes in all. 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 NCT06510322, which also lists 20 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 23 Jan 2026.