Heart Failure With Reduced Ejection FractionNCT04539093
Endothelial Function in Mechanical Circulatory Support
An observational study of Heart Failure With Reduced Ejection Fraction and Endothelial Dysfunction, run by Medical College of Wisconsin at 1 site in United States.
Trial summary
The pathophysiology of HF is highly variable, with overlapping pathogenic mechanisms that complicates any attempt to create a simple and unified conceptual model. Left ventricular (LV) ejection fraction (EF), assessed as the fraction of the end-diastolic volume that is ejected upon contraction, has been the… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Heart Failure With Reduced Ejection Fraction, Endothelial Dysfunction, LVAD
- What is being tested?
- Exposure of interest - Use of left ventricular assist device (LVAD)
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2022to 11 Nov 2022
- Phase
- Observational
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: End-stage heart failure patients at an academic medical center who are scheduled for LVAD implantation, will be screened for their candidacy in this study.
Who may be able to join
- Patients over the age of 18 years, deemed to be candidates for LVAD implantation. All ethnicities will be included in this study.
Who cannot join
- Age < 18 years or > 85 years.
- Presence of intra-cardiac shunt - safety concern for use of Echo contrast.
- Patient requiring temporary MCS - high acuity; may not be feasible to perform baseline assessment.
- Severe peripheral vascular disease - potential confounding bias during ultrasound assessment.
- Skeletal muscle disorder - not feasible to assess functional outcomes.
- Underlying/genetic vascular disease, i.e. vasculitis - potential for confounding bias during ultrasound assessment.
Show all 9Show fewer
- Pregnant women - potential risk to fetus.
- Non-English Speaking.
- Active alcohol or illicit substance use.
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
About this study
Official title: Assessment of Endothelial Function in Patients With Advanced Heart Failure Requiring Mechanical Circulatory Support
The pathophysiology of HF is highly variable, with overlapping pathogenic mechanisms that complicates any attempt to create a simple and unified conceptual model. Left ventricular (LV) ejection fraction (EF), assessed as the fraction of the end-diastolic volume that is ejected upon contraction, has been the cornerstone metric for characterization of LV systolic function in patients with HF. LVEF demonstrates a strong inverse relationship with clinical outcomes in HF in patients with reduced EF (HFrEF). Current management options for the treatment of HFrEF include medical management, mechanical circulatory support, and cardiac transplantation. In the setting of refractory end stage HFrEF, the standard of care is heart transplantation. Since limited organ procurement is a significant constraint to the treatment of patients with advanced disease, durable mechanical circulatory support (MCS) with left ventricular assist devices (LVAD) were developed as a safe and efficacious treatment strategy for patients with advanced HF that is refractory to medical therapy.
The advances in LVAD engineering and design, tailored towards defined physiological goals, have resulted in the creation of much smaller continuous-flow (CF) pumps that possess technical superiority, pump durability, and ease of implantation compared to the older and larger pulsatile-flow pumps. The addition of speed modulation algorithms to the next generation centrifugal CF LVADs, has decreased the incidence of device related adverse events.
Read more
Our interest lies in the impact of continuous flow hemodynamics on endothelial function and the cardiac and end-organ responses to this novel therapy. Current knowledge of the impact of these specific advances in LVAD therapy is however limited by the relative youth of the field. Thus, the goal of this research project is to study human LVAD patients and to determine the impact of speed modulation algorithms in CF physiology on microvascular and endothelial function and its association with cardiac and peripheral organ function.
The investigators hypothesize that restoration of cardiac output using an LVAD with modern speed modulation algorithm improves vascular endothelial function. In addition, these changes would have a positive correlation with functional outcomes.
Read the detailed description
The advances in LVAD engineering and design, tailored towards defined physiological goals, have resulted in the creation of much smaller CF pumps that possess technical superiority, pump durability, and ease of implantation compared to the older and larger PF pumps. The addition of artificial pulsatility to the next generation centrifugal CF LVADs, has decreased the incidence of device related adverse events. However, given the recent nature of these advances, the physiologic impact has yet to be fully elucidated. LVADs in general have demonstrated good outcomes and are rapidly gaining traction towards becoming standard therapy for refractory end stage HF. The investigators are in a position to study this new technology and the impact of the resultant altered physiologic state.
Our interest lies in the impact of continuous flow hemodynamics on endothelial function and the cardiac and end-organ responses to this novel therapy. Basal homeostatic properties of healthy endothelium are in part based on the effects of hemodynamic forces such as hydrostatic pressure, cyclic stretch, and fluid shear stress, which occur as a consequence of blood pressure and pulsatile blood flow in the vasculature. Under ambient conditions, these forces are generally atheroprotective and increase the expression of nitric oxide synthase (eNOS) to generate nitric oxide (NO), decrease reactive oxidative species (ROS) and oxidative stress, decrease expression of proinflammatory adhesion molecules, and maintain an antithrombotic surface. Increases in shear stress stimulate compensatory expansion of the vessels and thereby return shear forces to basal levels. Likewise, a decrease in shear stress can narrow the lumen of the vessel in an endothelium-dependent manner. In essence, the vessel remodels itself in response to long-term changes in flow, such that the luminal diameter is reshaped to maintain a constant predetermined level of shear stress. The capacity of the endothelium to sense shear stress is therefore an important determinant of luminal diameter and overall vessel structure. Failure to adapt to pathophysiological stimuli may lead to maladaptive responses that result in seemingly permanent alterations in endothelial phenotype and promote endothelial dysfunction. This phenomenon plays an integral role in several cardiovascular disease processes. Endothelial dysfunction (of both microvascular and conduit arteries) is a component of chronic heart failure and correlates with severity of disease. Improvement in cardiac function, whether via medical therapy or cardiac output augmentation, can improve endothelial function and benefit patients through better peripheral vascular reactivity. However, much of the improvement in endothelial function is thought to be related to the pulsatile laminar flow that occurs in majority of vascular beds. With the increasing use of CF pumps, it has become clear that the lack of pulsatility adversely affects the endothelium by decreasing vessel wall shear stress; reducing cyclic stretch that affects vascular cell proliferation; disrupting endothelium-dependent vasodilation; activating extrinsic pathway of thrombosis; and heightening vascular inflammation. The reintroduction of pulsatility through flow modulation control strategies could help mitigate these device specific issues and help promote endothelial recovery. Our knowledge of the impact of these specific advances in LVAD therapy is however limited by the relative youth of the field. Thus, the goal of this research project is to study human LVAD patients to determine the impact of artificial pulsatility in CF physiology on microvascular and endothelial function and its association with cardiac and peripheral organ function.
- Being tested
- Exposure of interest - Use of left ventricular assist device (LVAD)
- Keywords
- Observational, Pilot study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exposure of interest - Use of left ventricular assist device (LVAD)Other
Mechanical circulatory support devices such as left ventricular assist device is used as a treatment option for patients with end-stage heart failure.
| Study group | Role | What they receive |
|---|---|---|
| End-stage heart failure patients requiring lvad support | Patients with end-stage heart failure with reduced ejection fraction, requiring mechanical circulatory support. Receives: Other: Exposure of interest - Use of left ventricular assist device (LVAD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of endothelial function
Measurement of blood nitric oxide levels will be used to evaluate vascular endothelial function. Flow-mediated dilation technique will then be used as a barometer of nitric oxide availability. The concentration of nitric oxide levels and degree of flow-mediated dilation would correlate with endothelial function.
Measured: 9 months
Evaluation of microvascular function
Contrast enhanced ultrasound of the peripheral skeletal muscle of lower extremities will be used to evaluate microvascular function. Blood flow quantified using the ultrasound images would correlated with microvascular function.
Measured: 9 months
Secondary outcomes (5)
Functional outcomes - Quality of Life
The Kansas City Cardiomyopathy Questionnaire (KCCQ) is a 23-item self-administered questionnaire that helps quantify the impact of heart failure on quality of life. This score will be used to determine correlations with endothelial function.
Measured: 9 months
Functional outcomes - Mobility
The six-minute walk test (6MWT) is an index of physical function in patients with heart failure. The walking distance achieved by the 6MWT will be used to determine correlations with endothelial function.
Measured: 9 months
Functional outcomes - Handgrip
Handgrip strength (HGS) measured by using a handheld dynamometer is a simple and effective means of assessing peripheral muscle strength. The degree of HGS will be used to determine correlations with endothelial function.
Measured: 9 months
Functional outcomes - Lower extremity strength
The Five-repetition sit-to-stand test (FRSTST) is a widely used measure of lower extremity strength in clinical research and practice. The time taken to complete the test will be used to determine correlations with endothelial function.
Measured: 9 months
Functional outcomes - Ventilation and gas exchange
The Cardiopulmonary Exercise Test (CPET) provides breath-by-breath gas exchange measures of 3 variables: O2 uptake (VO2), carbon dioxide output (VCO2), and ventilation (VE). These 3 measures will be used to determine correlations with endothelial function.
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2020
- Study start1 Jan 2022
- Primary completion11 Nov 2022
- Study completion11 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (25)Papers the sponsor has linked to this study.
- Other trials for Heart Failure With Reduced Ejection FractionStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nicole Lohr, Medical College of Wisconsin
- Investigators
- Nicole L Lohr, MD PhD, Principal investigator, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04539093
- Sponsor's protocol ID
- PRO00038133
- Status last verified
- Oct 2023
- First submitted
- 14 Aug 2020
- Last updated
- 23 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Request not yet submitted to institution's Human Subject Protection Review Board.
Publications
Mehra MR. The burden of haemocompatibility with left ventricular assist systems: a complex weave. Eur Heart J. 2019 Feb 21;40(8):673-677. doi: 10.1093/eurheartj/ehx036. No abstract available.
PubMed 28329374Kumar J, Elhassan A, Dimitrova G, Essandoh M. The Lavare Cycle: A Novel Pulsatile Feature of the HVAD Continuous-Flow Left Ventricular Assist Device. J Cardiothorac Vasc Anesth. 2019 Apr;33(4):1170-1171. doi: 10.1053/j.jvca.2018.11.029. Epub 2018 Nov 22. No abstract available.
PubMed 30630656Benjamin EJ, Muntner P, Alonso A, Bittencourt MS, Callaway CW, Carson AP, Chamberlain AM, Chang AR, Cheng S, Das SR, Delling FN, Djousse L, Elkind MSV, Ferguson JF, Fornage M, Jordan LC, Khan SS, Kissela BM, Knutson KL, Kwan TW, Lackland DT, Lewis TT, Lichtman JH, Longenecker CT, Loop MS, Lutsey PL, Martin SS, Matsushita K, Moran AE, Mussolino ME, O'Flaherty M, Pandey A, Perak AM, Rosamond WD, Roth GA, Sampson UKA, Satou GM, Schroeder EB, Shah SH, Spartano NL, Stokes A, Tirschwell DL, Tsao CW, Turakhia MP, VanWagner LB, Wilkins JT, Wong SS, Virani SS; American Heart Association Council on Epidemiology and Prevention Statistics Committee and Stroke Statistics Subcommittee. Heart Disease and Stroke Statistics-2019 Update: A Report From the American Heart Association. Circulation. 2019 Mar 5;139(10):e56-e528. doi: 10.1161/CIR.0000000000000659. No abstract available.
PubMed 30700139Essandoh M, Essandoh G, Stallkamp ED Jr, Perez WJ. Spectral Doppler Analysis of the HeartMate 3 Left Ventricular Assist Device Inflow: New Challenges Presented by the Artificial Pulse Technology. J Cardiothorac Vasc Anesth. 2018 Dec;32(6):e4-e5. doi: 10.1053/j.jvca.2018.07.005. Epub 2018 Jul 7. No abstract available.
PubMed 30108022Yost G, Bhat G. Relationship Between Handgrip Strength and Length of Stay for Left Ventricular Assist Device Implantation. Nutr Clin Pract. 2017 Feb;32(1):98-102. doi: 10.1177/0884533616665926. Epub 2016 Sep 25.
PubMed 27600398Steiner J, Wiafe S, Camuso J, Milley K, Wooster LT, Bailey CS, Thomas SS, D'Alessandro DA, Garcia JP, Lewis GD. Predicting Success: Left Ventricular Assist Device Explantation Evaluation Protocol Using Comprehensive Cardiopulmonary Exercise Testing. Circ Heart Fail. 2017 Jan;10(1):e003694. doi: 10.1161/CIRCHEARTFAILURE.116.003694. No abstract available.
PubMed 27998882Rogers JG, Pagani FD, Tatooles AJ, Bhat G, Slaughter MS, Birks EJ, Boyce SW, Najjar SS, Jeevanandam V, Anderson AS, Gregoric ID, Mallidi H, Leadley K, Aaronson KD, Frazier OH, Milano CA. Intrapericardial Left Ventricular Assist Device for Advanced Heart Failure. N Engl J Med. 2017 Feb 2;376(5):451-460. doi: 10.1056/NEJMoa1602954.
PubMed 28146651Mehra MR, Naka Y, Uriel N, Goldstein DJ, Cleveland JC Jr, Colombo PC, Walsh MN, Milano CA, Patel CB, Jorde UP, Pagani FD, Aaronson KD, Dean DA, McCants K, Itoh A, Ewald GA, Horstmanshof D, Long JW, Salerno C; MOMENTUM 3 Investigators. A Fully Magnetically Levitated Circulatory Pump for Advanced Heart Failure. N Engl J Med. 2017 Feb 2;376(5):440-450. doi: 10.1056/NEJMoa1610426. Epub 2016 Nov 16.
PubMed 27959709Dokainish H, Teo K, Zhu J, Roy A, AlHabib KF, ElSayed A, Palileo-Villaneuva L, Lopez-Jaramillo P, Karaye K, Yusoff K, Orlandini A, Sliwa K, Mondo C, Lanas F, Prabhakaran D, Badr A, Elmaghawry M, Damasceno A, Tibazarwa K, Belley-Cote E, Balasubramanian K, Islam S, Yacoub MH, Huffman MD, Harkness K, Grinvalds A, McKelvie R, Bangdiwala SI, Yusuf S; INTER-CHF Investigators. Global mortality variations in patients with heart failure: results from the International Congestive Heart Failure (INTER-CHF) prospective cohort study. Lancet Glob Health. 2017 Jul;5(7):e665-e672. doi: 10.1016/S2214-109X(17)30196-1. Epub 2017 May 3.
PubMed 28476564Bristow MR, Kao DP, Breathett KK, Altman NL, Gorcsan J 3rd, Gill EA, Lowes BD, Gilbert EM, Quaife RA, Mann DL. Structural and Functional Phenotyping of the Failing Heart: Is the Left Ventricular Ejection Fraction Obsolete? JACC Heart Fail. 2017 Nov;5(11):772-781. doi: 10.1016/j.jchf.2017.09.009.
PubMed 29096787Zimpfer D, Strueber M, Aigner P, Schmitto JD, Fiane AE, Larbalestier R, Tsui S, Jansz P, Simon A, Schueler S, Moscato F, Schima H. Evaluation of the HeartWare ventricular assist device Lavare cycle in a particle image velocimetry model and in clinical practice. Eur J Cardiothorac Surg. 2016 Nov;50(5):839-848. doi: 10.1093/ejcts/ezw232. Epub 2016 Sep 7.
PubMed 27605222Malhotra R, Bakken K, D'Elia E, Lewis GD. Cardiopulmonary Exercise Testing in Heart Failure. JACC Heart Fail. 2016 Aug;4(8):607-16. doi: 10.1016/j.jchf.2016.03.022. Epub 2016 Jun 8.
PubMed 27289406Lee M, Akashi H, Kato TS, Takayama H, Wu C, Xu K, Collado E, Weber MP, Kennel PJ, Brunjes DL, Ji R, Naka Y, George I, Mancini D, Farr M, Schulze PC. Vascular inflammation and abnormal aortic histomorphometry in patients after pulsatile- and continuous-flow left ventricular assist device placement. J Heart Lung Transplant. 2016 Sep;35(9):1085-91. doi: 10.1016/j.healun.2015.12.027. Epub 2016 Jan 6.
PubMed 26899764Schmitto JD, Hanke JS, Rojas SV, Avsar M, Haverich A. First implantation in man of a new magnetically levitated left ventricular assist device (HeartMate III). J Heart Lung Transplant. 2015 Jun;34(6):858-60. doi: 10.1016/j.healun.2015.03.001. Epub 2015 Mar 7. No abstract available.
PubMed 25920932Moazami N, Dembitsky WP, Adamson R, Steffen RJ, Soltesz EG, Starling RC, Fukamachi K. Does pulsatility matter in the era of continuous-flow blood pumps? J Heart Lung Transplant. 2015 Aug;34(8):999-1004. doi: 10.1016/j.healun.2014.09.012. Epub 2014 Sep 28.
PubMed 25447568
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Endothelial Function in Patients With Advanced Heart Failure Requiring Mechanical Circulatory Support
- ClinicalTrials.gov ID
- NCT04539093
- Acronym / sponsor ID
- PRO00038133
- Keywords
- Observational, Pilot study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 11 Nov 2022 (actual)
- Study completion
- 11 Nov 2022 (actual)
- First posted
- 4 Sep 2020 (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.
The pathophysiology of HF is highly variable, with overlapping pathogenic mechanisms that complicates any attempt to create a simple and unified conceptual model. Left ventricular (LV) ejection fraction (EF), assessed as the fraction of the end-diastolic volume that is ejected upon contraction, has been the cornerstone metric for characterization of LV systolic function in patients with HF. LVEF demonstrates a strong inverse relationship with clinical outcomes in HF in patients with reduced EF (HFrEF). Current management options for the treatment of HFrEF include medical management, mechanical circulatory support, and cardiac transplantation. In the setting of refractory end stage HFrEF, the standard of care is heart transplantation. Since limited organ procurement is a significant constraint to the treatment of patients with advanced disease, durable mechanical circulatory support (MCS) with left ventricular assist devices (LVAD) were developed as a safe and efficacious treatment strategy for patients with advanced HF that is refractory to medical therapy.
The advances in LVAD engineering and design, tailored towards defined physiological goals, have resulted in the creation of much smaller continuous-flow (CF) pumps that possess technical superiority, pump durability, and ease of implantation compared to the older and larger pulsatile-flow pumps. The addition of speed modulation algorithms to the next generation centrifugal CF LVADs, has decreased the incidence of device related adverse events.
Our interest lies in the impact of continuous flow hemodynamics on endothelial function and the cardiac and end-organ responses to this novel therapy. Current knowledge of the impact of these specific advances in LVAD therapy is however limited by the relative youth of the field. Thus, the goal of this research project is to study human LVAD patients and to determine the impact of speed modulation algorithms in CF physiology on microvascular and endothelial function and its association with cardiac and peripheral organ function.
The investigators hypothesize that restoration of cardiac output using an LVAD with modern speed modulation algorithm improves vascular endothelial function. In addition, these changes would have a positive correlation with functional outcomes.
Detailed description
The advances in LVAD engineering and design, tailored towards defined physiological goals, have resulted in the creation of much smaller CF pumps that possess technical superiority, pump durability, and ease of implantation compared to the older and larger PF pumps. The addition of artificial pulsatility to the next generation centrifugal CF LVADs, has decreased the incidence of device related adverse events. However, given the recent nature of these advances, the physiologic impact has yet to be fully elucidated. LVADs in general have demonstrated good outcomes and are rapidly gaining traction towards becoming standard therapy for refractory end stage HF. The investigators are in a position to study this new technology and the impact of the resultant altered physiologic state.
Our interest lies in the impact of continuous flow hemodynamics on endothelial function and the cardiac and end-organ responses to this novel therapy. Basal homeostatic properties of healthy endothelium are in part based on the effects of hemodynamic forces such as hydrostatic pressure, cyclic stretch, and fluid shear stress, which occur as a consequence of blood pressure and pulsatile blood flow in the vasculature. Under ambient conditions, these forces are generally atheroprotective and increase the expression of nitric oxide synthase (eNOS) to generate nitric oxide (NO), decrease reactive oxidative species (ROS) and oxidative stress, decrease expression of proinflammatory adhesion molecules, and maintain an antithrombotic surface. Increases in shear stress stimulate compensatory expansion of the vessels and thereby return shear forces to basal levels. Likewise, a decrease in shear stress can narrow the lumen of the vessel in an endothelium-dependent manner. In essence, the vessel remodels itself in response to long-term changes in flow, such that the luminal diameter is reshaped to maintain a constant predetermined level of shear stress. The capacity of the endothelium to sense shear stress is therefore an important determinant of luminal diameter and overall vessel structure. Failure to adapt to pathophysiological stimuli may lead to maladaptive responses that result in seemingly permanent alterations in endothelial phenotype and promote endothelial dysfunction. This phenomenon plays an integral role in several cardiovascular disease processes. Endothelial dysfunction (of both microvascular and conduit arteries) is a component of chronic heart failure and correlates with severity of disease. Improvement in cardiac function, whether via medical therapy or cardiac output augmentation, can improve endothelial function and benefit patients through better peripheral vascular reactivity. However, much of the improvement in endothelial function is thought to be related to the pulsatile laminar flow that occurs in majority of vascular beds. With the increasing use of CF pumps, it has become clear that the lack of pulsatility adversely affects the endothelium by decreasing vessel wall shear stress; reducing cyclic stretch that affects vascular cell proliferation; disrupting endothelium-dependent vasodilation; activating extrinsic pathway of thrombosis; and heightening vascular inflammation. The reintroduction of pulsatility through flow modulation control strategies could help mitigate these device specific issues and help promote endothelial recovery. Our knowledge of the impact of these specific advances in LVAD therapy is however limited by the relative youth of the field. Thus, the goal of this research project is to study human LVAD patients to determine the impact of artificial pulsatility in CF physiology on microvascular and endothelial function and its association with cardiac and peripheral organ function.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| End-stage heart failure patients requiring lvad support | – | Other: Exposure of interest - Use of left ventricular assist device (LVAD)Patients with end-stage heart failure with reduced ejection fraction, requiring mechanical circulatory support. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- End-stage heart failure patients at an academic medical center who are scheduled for LVAD implantation, will be screened for their candidacy in this study.
Key inclusion criteria (1 listed)
- Patients over the age of 18 years, deemed to be candidates for LVAD implantation. All ethnicities will be included in this study.
Key exclusion criteria (9 listed)
- Age < 18 years or > 85 years.
- Presence of intra-cardiac shunt - safety concern for use of Echo contrast.
- Patient requiring temporary MCS - high acuity; may not be feasible to perform baseline assessment.
- Severe peripheral vascular disease - potential confounding bias during ultrasound assessment.
- Skeletal muscle disorder - not feasible to assess functional outcomes.
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 |
|---|---|---|
| Exposure of interest - Use of left ventricular assist device (LVAD)Mechanical circulatory support devices such as left ventricular assist device is used as a treatment option for patients with end-stage heart failure. | Other | End-stage heart failure patients requiring lvad support |
Primary outcome
Evaluation of endothelial function
Time frame: 9 months
Measurement of blood nitric oxide levels will be used to evaluate vascular endothelial function. Flow-mediated dilation technique will then be used as a barometer of nitric oxide availability. The concentration of nitric oxide levels and degree of flow-mediated dilation would correlate with endothelial function.
Evaluation of microvascular function
Time frame: 9 months
Contrast enhanced ultrasound of the peripheral skeletal muscle of lower extremities will be used to evaluate microvascular function. Blood flow quantified using the ultrasound images would correlated with microvascular function.
5 secondary outcomes
Functional outcomes - Quality of Life
Time frame: 9 months
Functional outcomes - Mobility
Time frame: 9 months
Functional outcomes - Handgrip
Time frame: 9 months
Functional outcomes - Lower extremity strength
Time frame: 9 months
Functional outcomes - Ventilation and gas exchange
Time frame: 9 months
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 23 Oct 2023.
- Background: PubMed 28329374Mehra MR. The burden of haemocompatibility with left ventricular assist systems: a complex weave. Eur Heart J. 2019 Feb 21;40(8):673-677. doi: 10.1093/eurheartj/ehx036. No abstract available.
- Background: PubMed 30630656Kumar J, Elhassan A, Dimitrova G, Essandoh M. The Lavare Cycle: A Novel Pulsatile Feature of the HVAD Continuous-Flow Left Ventricular Assist Device. J Cardiothorac Vasc Anesth. 2019 Apr;33(4):1170-1171. doi: 10.1053/j.jvca.2018.11.029. Epub 2018 Nov 22. No abstract available.
- Background: PubMed 30700139Benjamin EJ, Muntner P, Alonso A, Bittencourt MS, Callaway CW, Carson AP, Chamberlain AM, Chang AR, Cheng S, Das SR, Delling FN, Djousse L, Elkind MSV, Ferguson JF, Fornage M, Jordan LC, Khan SS, Kissela BM, Knutson KL, Kwan TW, Lackland DT, Lewis TT, Lichtman JH, Longenecker CT, Loop MS, Lutsey PL, Martin SS, Matsushita K, Moran AE, Mussolino ME, O'Flaherty M, Pandey A, Perak AM, Rosamond WD, Roth GA, Sampson UKA, Satou GM, Schroeder EB, Shah SH, Spartano NL, Stokes A, Tirschwell DL, Tsao CW, Turakhia MP, VanWagner LB, Wilkins JT, Wong SS, Virani SS; American Heart Association Council on Epidemiology and Prevention Statistics Committee and Stroke Statistics Subcommittee. Heart Disease and Stroke Statistics-2019 Update: A Report From the American Heart Association. Circulation. 2019 Mar 5;139(10):e56-e528. doi: 10.1161/CIR.0000000000000659. No abstract available.
- Background: PubMed 30108022Essandoh M, Essandoh G, Stallkamp ED Jr, Perez WJ. Spectral Doppler Analysis of the HeartMate 3 Left Ventricular Assist Device Inflow: New Challenges Presented by the Artificial Pulse Technology. J Cardiothorac Vasc Anesth. 2018 Dec;32(6):e4-e5. doi: 10.1053/j.jvca.2018.07.005. Epub 2018 Jul 7. No abstract available.
- Background: PubMed 27600398Yost G, Bhat G. Relationship Between Handgrip Strength and Length of Stay for Left Ventricular Assist Device Implantation. Nutr Clin Pract. 2017 Feb;32(1):98-102. doi: 10.1177/0884533616665926. Epub 2016 Sep 25.
- Background: PubMed 27998882Steiner J, Wiafe S, Camuso J, Milley K, Wooster LT, Bailey CS, Thomas SS, D'Alessandro DA, Garcia JP, Lewis GD. Predicting Success: Left Ventricular Assist Device Explantation Evaluation Protocol Using Comprehensive Cardiopulmonary Exercise Testing. Circ Heart Fail. 2017 Jan;10(1):e003694. doi: 10.1161/CIRCHEARTFAILURE.116.003694. No abstract available.
- Background: PubMed 28146651Rogers JG, Pagani FD, Tatooles AJ, Bhat G, Slaughter MS, Birks EJ, Boyce SW, Najjar SS, Jeevanandam V, Anderson AS, Gregoric ID, Mallidi H, Leadley K, Aaronson KD, Frazier OH, Milano CA. Intrapericardial Left Ventricular Assist Device for Advanced Heart Failure. N Engl J Med. 2017 Feb 2;376(5):451-460. doi: 10.1056/NEJMoa1602954.
- Background: PubMed 27959709Mehra MR, Naka Y, Uriel N, Goldstein DJ, Cleveland JC Jr, Colombo PC, Walsh MN, Milano CA, Patel CB, Jorde UP, Pagani FD, Aaronson KD, Dean DA, McCants K, Itoh A, Ewald GA, Horstmanshof D, Long JW, Salerno C; MOMENTUM 3 Investigators. A Fully Magnetically Levitated Circulatory Pump for Advanced Heart Failure. N Engl J Med. 2017 Feb 2;376(5):440-450. doi: 10.1056/NEJMoa1610426. Epub 2016 Nov 16.
- Background: PubMed 28476564Dokainish H, Teo K, Zhu J, Roy A, AlHabib KF, ElSayed A, Palileo-Villaneuva L, Lopez-Jaramillo P, Karaye K, Yusoff K, Orlandini A, Sliwa K, Mondo C, Lanas F, Prabhakaran D, Badr A, Elmaghawry M, Damasceno A, Tibazarwa K, Belley-Cote E, Balasubramanian K, Islam S, Yacoub MH, Huffman MD, Harkness K, Grinvalds A, McKelvie R, Bangdiwala SI, Yusuf S; INTER-CHF Investigators. Global mortality variations in patients with heart failure: results from the International Congestive Heart Failure (INTER-CHF) prospective cohort study. Lancet Glob Health. 2017 Jul;5(7):e665-e672. doi: 10.1016/S2214-109X(17)30196-1. Epub 2017 May 3.
- Background: PubMed 29096787Bristow MR, Kao DP, Breathett KK, Altman NL, Gorcsan J 3rd, Gill EA, Lowes BD, Gilbert EM, Quaife RA, Mann DL. Structural and Functional Phenotyping of the Failing Heart: Is the Left Ventricular Ejection Fraction Obsolete? JACC Heart Fail. 2017 Nov;5(11):772-781. doi: 10.1016/j.jchf.2017.09.009.
- Background: PubMed 27605222Zimpfer D, Strueber M, Aigner P, Schmitto JD, Fiane AE, Larbalestier R, Tsui S, Jansz P, Simon A, Schueler S, Moscato F, Schima H. Evaluation of the HeartWare ventricular assist device Lavare cycle in a particle image velocimetry model and in clinical practice. Eur J Cardiothorac Surg. 2016 Nov;50(5):839-848. doi: 10.1093/ejcts/ezw232. Epub 2016 Sep 7.
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- Individual participant dataSharing planned: Undecided. Request not yet submitted to institution's Human Subject Protection Review Board.
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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. This study is not recruiting at the moment.
Nicole L Lohr, MD PhD principal investigator
Medical College of Wisconsin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure With Reduced Ejection Fraction and Endothelial Dysfunction, run by Medical College of Wisconsin 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 1 inclusion and 9 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 23 Oct 2023. 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. 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?
Evaluation of endothelial function (time frame: 9 months). The study lists 2 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 NCT04539093, which also lists 25 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 Oct 2023.