Heart FailureNCT03238690
LVAD Conditioning for Cardiac Recovery
A study of Heart Failure, run by STAVROS G DRAKOS at 1 site in United States.
Trial summary
The purpose of this study is to investigate the potential recovery of heart function in end-stage heart failure patients supported with a Left Ventricular Assist Device (LVAD) through applying a myocardial conditioning protocol. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jun 2017to 30 Jun 2028
- Phase
- Interventional
- 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
- Diagnosed with heart failure undergoing LVAD implantation as a bridge to transplant
- Enrolled in the Effects of Mechanical Unloading on Myocardial Function and Structure study (IRB 30622)
Who cannot join
- Neither the subject nor the subject's representative is willing to provide written consent for participation
- Subjects with adverse events leading to hospitalization during the optimum unloading phase are excluded from participation in the controlled reloading phase
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Utah
Salt Lake City, Utah, 84112
Stavros Drakos, MD, 801-585-2340, stavros.drakos@hsc.utah.edu
Stavros Drakos, MD
About this study
Official title: Sequential Left Ventricular Assist Device (LVAD) Unloading and Conditioning to Induce Sustained Cardiac Recovery
The purpose of this study is to investigate the potential recovery of heart function in end-stage heart failure patients supported with a Left Ventricular Assist Device (LVAD) through applying a myocardial conditioning protocol. During myocardial conditioning, LVAD speed is reduced gradually in order to increase the work load of the heart. Multiple previous studies have shown that interventions like this may improve heart function and give patients the opportunity for a better quality of life.
Read the detailed description
Heart failure can be caused by various disorders, such as myocardial infarction, hypertension, viral infection, exposure to toxins, chemotherapy, or genetically transmitted muscular diseases. Regardless of the etiology, these disorders initiate ventricular remodeling, an adaptive, compensatory process which becomes progressively maladaptive and the cause of functional and clinical deterioration, eventually leading to heart failure. Local and systemic compensatory responses that initially allow surviving muscle to maintain hemodynamic function continue over time and due to this persistent compensatory over-activity the initially unaffected myocardium becomes dysfunctional. These compensatory responses to an abnormal cardiac load or myocardial injury involve several pathophysiological adaptations in the cardiac structure at the genetic, molecular, cellular, and tissue levels. Furthermore, left ventricular pressure and volume overload has shown to alter metabolic substrate utilization, decrease mitochondrial function and reduce energy production in the failing heart.
Mechanical circulatory support with LVAD has become a standard bridge to cardiac transplantation, and has also been approved in the United States as permanent (destination) therapy for selected patients presenting with end-stage heart failure. Clinical experience with LVAD support has shown that it can reverse the complex process of chronic left ventricular remodeling to a point where a subset of patients could be weaned from the device after restoration of basic cardiac function. LVAD-induced mechanical unloading of the failing heart leads to reduced mitochondrial density, structure and function, and interventions that enhance mitochondrial biogenesis, function and structure, such as controlled cardiac reloading may enhance LVAD-induced myocardial reverse remodeling and cardiac recovery. This study is designed to investigate gradual reduction in LVAD speed within the range defined by the assist device manufacturer's manual as appropriate for regular clinic use, to determine the effect on reverse remodeling and myocardial recovery in end-stage heart failure patients.
- Conditions
- Heart Failure
- Being tested
- Controlled Cardiac Reloading through LVAD Speed Adjustment
- Keywords
- LVAD, Cardiac Recovery
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Controlled Cardiac Reloading through LVAD Speed AdjustmentDevice
LVAD speed is reduced at a fixed rate according to the particular LVAD device model implanted. LVAD speed reduction adjustments will be performed at visits occurring every 2 - 3 weeks, up to a total of 8 visits. Reduction of LVAD speed will continue until the soonest of: minimum operating setting as recommended in the LVAD Operator's manual is reached; the minimum setting tolerated by the subject is reached; the subject completes 8 visits; or until the subject receives a heart transplant.
| Study group | Role | What they receive |
|---|---|---|
| Controlled Cardiac Reloading | Experimental | Heart failure patients with recent LVAD implantation after an optimum unloading phase, will undergo controlled cardiac reloading through LVAD speed adjustment reductions in a controlled reloading phase Receives: Device: Controlled Cardiac Reloading through LVAD Speed Adjustment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Left Ventricular Ejection Fraction (LVEF)
LVEF is measured by echocardiography. The average change in LVEF from baseline to 12 months or transplant in the study participant arm will be compared to results from an historical control group.
Measured: Baseline (prior to LVAD implantation) and 12 months post-LVAD implantation, or at time of LVAD explantation/heart transplant
Secondary outcomes (16)
Change in Left Ventricular End Diastolic Diameter (LVEDD)
LVEDD is measured by echocardiography. The average change in LVEDD from baseline to 12 months or transplant in the study participant arm will be compared to results from an historical control group.
Measured: Baseline (prior to LVAD implantation) and 12 months post-LVAD implantation, or at time of LVAD explantation/heart transplant
Change in Left Ventricular End Systolic Diameter (LVESD)
LVESD is measured by echocardiography. The average change in LVESD from baseline to 12 months or transplant in the study participant arm will be compared to results from an historical control group.
Measured: Baseline (prior to LVAD implantation) and 12 months post-LVAD implantation, or at time of LVAD explantation/heart transplant
Change in Left Ventricular End Diastolic Volume (LVEDV)
LVEDV is measured by echocardiography. The average change in LVEDV from baseline to 12 months or transplant in the study participant arm will be compared to results from an historical control group.
Measured: Baseline (prior to LVAD implantation) and 12 months post-LVAD implantation, or at time of LVAD explantation/heart transplant
Change in Left Ventricular End Systolic Volume (LVESV)
LVESV is measured by echocardiography. The average change in LVESV from baseline to 12 months or transplant in the study participant arm will be compared to results from an historical control group.
Measured: Baseline (prior to LVAD implantation) and 12 months post-LVAD implantation, or at time of LVAD explantation/heart transplant
Change in heart tissue Glucose 1-phosphate levels
Heart tissue samples will be collected at LVAD implantation when the tissue from the core becomes available and then at explant when the whole heart becomes available, and will be analyzed for Glucose 1-phosphate levels. The average change in Glucose 1-phosphate from baseline to transplant in the study participant arm will be compared to results from an historical control group.
Measured: Baseline (LVAD implantation) and at time of LVAD explantation/heart transplantation (up to 12 months)
Change in heart tissue Glucose 6-phosphate levels
Heart tissue samples will be collected at LVAD implantation when the tissue from the core becomes available and then at explant when the whole heart becomes available, and will be analyzed for Glucose 6-phosphate levels. The average change in Glucose 6-phosphate from baseline to transplant in the study participant arm will be compared to results from an historical control group.
Measured: Baseline (LVAD implantation) and at time of LVAD explantation/heart transplantation (up to 12 months)
Change in heart tissue Pyruvate levels
Heart tissue samples will be collected at LVAD implantation when the tissue from the core becomes available and then at explant when the whole heart becomes available, and will be analyzed for Pyruvate levels. The average change in Pyruvate from baseline to transplant in the study participant arm will be compared to results from an historical control group.
Measured: Baseline (LVAD implantation) and at time of LVAD explantation/heart transplantation (up to 12 months)
Change in heart tissue Lactic Acid levels
Heart tissue samples will be collected at LVAD implantation when the tissue from the core becomes available and then at explant when the whole heart becomes available, and will be analyzed for Lactic Acid levels. The average change in Lactic Acid from baseline to transplant in the study participant arm will be compared to results from an historical control group.
Measured: Baseline (LVAD implantation) and at time of LVAD explantation/heart transplantation (up to 12 months)
Change in heart tissue Acetyl Coenzyme A levels
Heart tissue samples will be collected at LVAD implantation when the tissue from the core becomes available and then at explant when the whole heart becomes available, and will be analyzed for Acetyl Coenzyme A levels. The average change in Acetyl Coenzyme A from baseline to transplant in the study participant arm will be compared to results from an historical control group.
Measured: Baseline (LVAD implantation) and at time of LVAD explantation/heart transplantation (up to 12 months)
Change in heart tissue Glucose Transporter 1 (GLUT1) levels
Heart tissue samples will be collected at LVAD implantation when the tissue from the core becomes available and then at explant when the whole heart becomes available, and will be analyzed for GLUT1 levels. The average change in GLUT1 from baseline to transplant in the study participant arm will be compared to results from an historical control group.
Measured: Baseline (LVAD implantation) and at time of LVAD explantation/heart transplantation (up to 12 months)
Change in heart tissue Glucose Transporter 1 (GLUT1) messenger ribonucleic acid (mRNA) levels
Heart tissue samples will be collected at LVAD implantation when the tissue from the core becomes available and then at explant when the whole heart becomes available, and will be analyzed for GLUT1 mRNA levels. The average change in GLUT1 mRNA from baseline to transplant in the study participant arm will be compared to results from an historical control group.
Measured: Baseline (LVAD implantation) and at time of LVAD explantation/heart transplantation (up to 12 months)
Change in heart tissue Glucose Transporter 4 (GLUT4) levels
Heart tissue samples will be collected at LVAD implantation when the tissue from the core becomes available and then at explant when the whole heart becomes available, and will be analyzed for GLUT4 levels. The average change in GLUT4 from baseline to transplant in the study participant arm will be compared to results from an historical control group.
Measured: Baseline (LVAD implantation) and at time of LVAD explantation/heart transplantation (up to 12 months)
Change in heart tissue Glucose Transporter 4 (GLUT4) messenger ribonucleic acid (mRNA) levels
Heart tissue samples will be collected at LVAD implantation when the tissue from the core becomes available and then at explant when the whole heart becomes available, and will be analyzed for GLUT4 mRNA levels. The average change in GLUT4 mRNA from baseline to transplant in the study participant arm will be compared to results from an historical control group.
Measured: Baseline (LVAD implantation) and at time of LVAD explantation/heart transplantation (up to 12 months)
Change in heart tissue Mitochondrial Pyruvate Carrier 1 (MPC1) levels
Heart tissue samples will be collected at LVAD implantation when the tissue from the core becomes available and then at explant when the whole heart becomes available, and will be analyzed for MPC1 levels. The average change in MPC1 from baseline to transplant in the study participant arm will be compared to results from an historical control group.
Measured: Baseline (LVAD implantation) and at time of LVAD explantation/heart transplantation (up to 12 months)
Change in heart tissue Mitochondrial Pyruvate Carrier 2 (MPC2) levels
Heart tissue samples will be collected at LVAD implantation when the tissue from the core becomes available and then at explant when the whole heart becomes available, and will be analyzed for MPC2 levels. The average change in MPC2 from baseline to transplant in the study participant arm will be compared to results from an historical control group.
Measured: Baseline (LVAD implantation) and at time of LVAD explantation/heart transplantation (up to 12 months)
Change in heart tissue Mitochondrial Density
Heart tissue samples will be collected at LVAD implantation when the tissue from the core becomes available and then at explant when the whole heart becomes available, and will be analyzed for mitochondrial density by electron microscopy. The average change in mitochondrial density from baseline to transplant in the study participant arm will be compared to results from an historical control group.
Measured: Baseline (LVAD implantation) and at time of LVAD explantation/heart transplantation (up to 12 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2017
- Study start23 Jun 2017
- Primary completion30 Jun 2028 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- STAVROS G DRAKOS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, STAVROS G DRAKOS, University of Utah
- Investigators
- Stavros Drakos, MD, Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03238690
- Sponsor's protocol ID
- IRB_00095106
- Status last verified
- Aug 2026
- First submitted
- 31 Jul 2017
- Last updated
- 13 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
George RS, Sabharwal NK, Webb C, Yacoub MH, Bowles CT, Hedger M, Khaghani A, Birks EJ. Echocardiographic assessment of flow across continuous-flow ventricular assist devices at low speeds. J Heart Lung Transplant. 2010 Nov;29(11):1245-52. doi: 10.1016/j.healun.2010.05.032. Epub 2010 Aug 5.
PubMed 20688540Healy AH, Koliopoulou A, Drakos SG, McKellar SH, Stehlik J, Selzman CH. Patient-controlled conditioning for left ventricular assist device-induced myocardial recovery. Ann Thorac Surg. 2015 May;99(5):1794-6. doi: 10.1016/j.athoracsur.2014.07.058.
PubMed 25952209Frazier OH, Baldwin AC, Demirozu ZT, Segura AM, Hernandez R, Taegtmeyer H, Mallidi H, Cohn WE. Ventricular reconditioning and pump explantation in patients supported by continuous-flow left ventricular assist devices. J Heart Lung Transplant. 2015 Jun;34(6):766-72. doi: 10.1016/j.healun.2014.09.015. Epub 2014 Sep 28.
PubMed 25447571
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sequential Left Ventricular Assist Device (LVAD) Unloading and Conditioning to Induce Sustained Cardiac Recovery
- ClinicalTrials.gov ID
- NCT03238690
- Acronym / sponsor ID
- IRB_00095106
- Conditions
- Heart Failure
- Keywords
- LVAD, Cardiac Recovery
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- STAVROS G DRAKOSUniversity, hospital or other
- Study start
- 23 Jun 2017 (actual)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 3 Aug 2017 (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 purpose of this study is to investigate the potential recovery of heart function in end-stage heart failure patients supported with a Left Ventricular Assist Device (LVAD) through applying a myocardial conditioning protocol. During myocardial conditioning, LVAD speed is reduced gradually in order to increase the work load of the heart. Multiple previous studies have shown that interventions like this may improve heart function and give patients the opportunity for a better quality of life.
Detailed description
Heart failure can be caused by various disorders, such as myocardial infarction, hypertension, viral infection, exposure to toxins, chemotherapy, or genetically transmitted muscular diseases. Regardless of the etiology, these disorders initiate ventricular remodeling, an adaptive, compensatory process which becomes progressively maladaptive and the cause of functional and clinical deterioration, eventually leading to heart failure. Local and systemic compensatory responses that initially allow surviving muscle to maintain hemodynamic function continue over time and due to this persistent compensatory over-activity the initially unaffected myocardium becomes dysfunctional. These compensatory responses to an abnormal cardiac load or myocardial injury involve several pathophysiological adaptations in the cardiac structure at the genetic, molecular, cellular, and tissue levels. Furthermore, left ventricular pressure and volume overload has shown to alter metabolic substrate utilization, decrease mitochondrial function and reduce energy production in the failing heart.
Mechanical circulatory support with LVAD has become a standard bridge to cardiac transplantation, and has also been approved in the United States as permanent (destination) therapy for selected patients presenting with end-stage heart failure. Clinical experience with LVAD support has shown that it can reverse the complex process of chronic left ventricular remodeling to a point where a subset of patients could be weaned from the device after restoration of basic cardiac function. LVAD-induced mechanical unloading of the failing heart leads to reduced mitochondrial density, structure and function, and interventions that enhance mitochondrial biogenesis, function and structure, such as controlled cardiac reloading may enhance LVAD-induced myocardial reverse remodeling and cardiac recovery. This study is designed to investigate gradual reduction in LVAD speed within the range defined by the assist device manufacturer's manual as appropriate for regular clinic use, to determine the effect on reverse remodeling and myocardial recovery in end-stage heart failure patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Controlled Cardiac Reloading | Experimental | Device: Controlled Cardiac Reloading through LVAD Speed AdjustmentHeart failure patients with recent LVAD implantation after an optimum unloading phase, will undergo controlled cardiac reloading through LVAD speed adjustment reductions in a controlled reloading phase |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosed with heart failure undergoing LVAD implantation as a bridge to transplant
- Enrolled in the Effects of Mechanical Unloading on Myocardial Function and Structure study (IRB 30622)
Key exclusion criteria (2 listed)
- Neither the subject nor the subject's representative is willing to provide written consent for participation
- Subjects with adverse events leading to hospitalization during the optimum unloading phase are excluded from participation in the controlled reloading phase
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 |
|---|---|---|
| Controlled Cardiac Reloading through LVAD Speed AdjustmentLVAD speed is reduced at a fixed rate according to the particular LVAD device model implanted. LVAD speed reduction adjustments will be performed at visits occurring every 2 - 3 weeks, up to a total of 8 visits. Reduction of LVAD speed will continue until the soonest of: minimum operating setting as recommended in the LVAD Operator's manual is reached; the minimum setting tolerated by the subject is reached; the subject completes 8 visits; or until the subject receives a heart transplant. | Device | Controlled Cardiac Reloading |
Primary outcome
Change in Left Ventricular Ejection Fraction (LVEF)
Time frame: Baseline (prior to LVAD implantation) and 12 months post-LVAD implantation, or at time of LVAD explantation/heart transplant
LVEF is measured by echocardiography. The average change in LVEF from baseline to 12 months or transplant in the study participant arm will be compared to results from an historical control group.
16 secondary outcomes
Change in Left Ventricular End Diastolic Diameter (LVEDD)
Time frame: Baseline (prior to LVAD implantation) and 12 months post-LVAD implantation, or at time of LVAD explantation/heart transplant
Change in Left Ventricular End Systolic Diameter (LVESD)
Time frame: Baseline (prior to LVAD implantation) and 12 months post-LVAD implantation, or at time of LVAD explantation/heart transplant
Change in Left Ventricular End Diastolic Volume (LVEDV)
Time frame: Baseline (prior to LVAD implantation) and 12 months post-LVAD implantation, or at time of LVAD explantation/heart transplant
Change in Left Ventricular End Systolic Volume (LVESV)
Time frame: Baseline (prior to LVAD implantation) and 12 months post-LVAD implantation, or at time of LVAD explantation/heart transplant
Change in heart tissue Glucose 1-phosphate levels
Time frame: Baseline (LVAD implantation) and at time of LVAD explantation/heart transplantation (up to 12 months)
Change in heart tissue Glucose 6-phosphate levels
Time frame: Baseline (LVAD implantation) and at time of LVAD explantation/heart transplantation (up to 12 months)
Change in heart tissue Pyruvate levels
Time frame: Baseline (LVAD implantation) and at time of LVAD explantation/heart transplantation (up to 12 months)
Change in heart tissue Lactic Acid levels
Time frame: Baseline (LVAD implantation) and at time of LVAD explantation/heart transplantation (up to 12 months)
Change in heart tissue Acetyl Coenzyme A levels
Time frame: Baseline (LVAD implantation) and at time of LVAD explantation/heart transplantation (up to 12 months)
Change in heart tissue Glucose Transporter 1 (GLUT1) levels
Time frame: Baseline (LVAD implantation) and at time of LVAD explantation/heart transplantation (up to 12 months)
Change in heart tissue Glucose Transporter 1 (GLUT1) messenger ribonucleic acid (mRNA) levels
Time frame: Baseline (LVAD implantation) and at time of LVAD explantation/heart transplantation (up to 12 months)
Change in heart tissue Glucose Transporter 4 (GLUT4) levels
Time frame: Baseline (LVAD implantation) and at time of LVAD explantation/heart transplantation (up to 12 months)
Change in heart tissue Glucose Transporter 4 (GLUT4) messenger ribonucleic acid (mRNA) levels
Time frame: Baseline (LVAD implantation) and at time of LVAD explantation/heart transplantation (up to 12 months)
Change in heart tissue Mitochondrial Pyruvate Carrier 1 (MPC1) levels
Time frame: Baseline (LVAD implantation) and at time of LVAD explantation/heart transplantation (up to 12 months)
Change in heart tissue Mitochondrial Pyruvate Carrier 2 (MPC2) levels
Time frame: Baseline (LVAD implantation) and at time of LVAD explantation/heart transplantation (up to 12 months)
Change in heart tissue Mitochondrial Density
Time frame: Baseline (LVAD implantation) and at time of LVAD explantation/heart transplantation (up to 12 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 13 Aug 2026.
- Background: PubMed 20688540George RS, Sabharwal NK, Webb C, Yacoub MH, Bowles CT, Hedger M, Khaghani A, Birks EJ. Echocardiographic assessment of flow across continuous-flow ventricular assist devices at low speeds. J Heart Lung Transplant. 2010 Nov;29(11):1245-52. doi: 10.1016/j.healun.2010.05.032. Epub 2010 Aug 5.
- Background: PubMed 25952209Healy AH, Koliopoulou A, Drakos SG, McKellar SH, Stehlik J, Selzman CH. Patient-controlled conditioning for left ventricular assist device-induced myocardial recovery. Ann Thorac Surg. 2015 May;99(5):1794-6. doi: 10.1016/j.athoracsur.2014.07.058.
- Background: PubMed 25447571Frazier OH, Baldwin AC, Demirozu ZT, Segura AM, Hernandez R, Taegtmeyer H, Mallidi H, Cohn WE. Ventricular reconditioning and pump explantation in patients supported by continuous-flow left ventricular assist devices. J Heart Lung Transplant. 2015 Jun;34(6):766-72. doi: 10.1016/j.healun.2014.09.015. Epub 2014 Sep 28.
- Individual participant dataSharing planned: No
Related trials for Heart Failure
Active, not recruiting
Neural Cardiac Therapy for Heart Failure Study (NECTAR-HF)
Heart Failure, Congestive Heart Failure
Active, not recruiting
Fast Induced Remodeling in Heart Failure With Preserved Ejection Fraction
Heart Failure With Preserved Ejection Fraction, Concentric Hypertrophy
Recruiting
Vsling™ III: Clinical Evaluation of the Vsling™ Device for Ventricular Repair in Patients With Heart Failure
HFrEF - Heart Failure With Reduced Ejection Fraction
RecruitingPhase 4
Empagliflozin in Heart Failure With Reduced Ejection Fraction and End Stage Renal Disease
Heart Failure With Reduced Ejection Fraction, End Stage Renal Disease on Dialysis
Enrolling by invitationObservational study
Multi-Scale Analysis of Phenotypes in Heart Failure (MAP-HEART)
Heart Failure
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.
Stavros Drakos, MD principal investigator
University of Utah
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Heart Failure, run by STAVROS G DRAKOS 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 2 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: looking for participants now, as of the sponsor's last update on 13 Aug 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. 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?
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 John Kirk (801-585-2944, john.kirk@hsc.utah.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Left Ventricular Ejection Fraction (LVEF) (time frame: Baseline (prior to LVAD implantation) and 12 months post-LVAD implantation, or at time of LVAD explantation/heart transplant). 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 NCT03238690, which also lists 3 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 13 Aug 2026; AzTrials last refreshed its copy on 29 Oct 2026.