Heart FailurePhase 4SUGAR-DM-HFNCT03485092
Studies of Empagliflozin and Its Cardiovascular, Renal and Metabolic Effects
A Phase 4 study testing Empagliflozin 10 MG in people with Heart Failure and Diabetes Mellitus, run by NHS Greater Glasgow and Clyde at 1 site in United Kingdom.
Trial summary
The investigators hypothesise that empagliflozin 10mg daily will have haemodynamic, cardiac, and renal benefits compared to placebo over 36 weeks in heart failure patients with type 2 diabetes (or pre-diabetes), leading to measurable improvements in clinical measures of cardiac structure and function (LVESVI, and LV… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Diabetes Mellitus
- What is being tested?
- Empagliflozin 10 MG
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 105 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 16 Mar 2018to 28 Mar 2020
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent
- Male or female, aged ≥18 years age
- Type 2 DM (diet-controlled or on stable treatment) or prediabetes
- Stable treatment defined as no change in oral therapy agents or doses for diabetes mellitus and (where applicable) <10% change in average total daily insulin dose over last 6 weeks
- HbA1c ≤97 mmol/mol (11%) (routine available data from medical records, recorded in the last year)
- Prediabetes defined as HbA1c 39-47 mmol/mol (5.7-6.4%) at the time of screening (specifically for the prediabetes group, HbA1c will be repeated at the time of screening if there are no recent results within the last 3 months, in order to confirm the diagnosis of prediabetes)
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- Heart failure (as defined by the presence of typical signs and symptoms of heart failure with documented reduced ejection fraction (ref SIGN and ESC guidelines))
- NYHA class II-IV
- LVEF ≤40%
- On stable doses of ACEI, ARB or ARNI for 4 weeks prior to randomisation unless contraindicated or not tolerated. They should also be taking a beta-blocker at a stable dose for 4 weeks unless contraindicated or not tolerated
- Women of childbearing potential (WOCBP) must be currently adhering to, or be willing to use, highly effective birth control methods for study treatment duration including:
- Combined hormonal contraception (oestrogen and progestogen containing medication) either orally, intravaginally, or transdermally
- Progesterone only hormonal contraception either orally, injected, or implanted
- Intrauterine device (IUD)
- Intrauterine hormone release system (IUS)
- Bilateral fallopian tube occlusion
- Vasectomised partner
- Complete sexual abstinence where this is their preferred and usual lifestyle
- WOCBP comprises women who have experienced menarche and who have not undergone successful surgical sterilisation (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or who are not post-menopausal. Post-menopausal is defined as:
- o Women who have had amenorrhea for ≥12 consecutive months (without another medical cause)
Who cannot join
- Type 1 DM
- History of hospital admission with a diagnosis of diabetic ketoacidosis (DKA)
- Insulin use within 1 year of diagnosis of diabetes
- History of acute or chronic pancreatitis
- eGFR <30 ml/min/1.73m2 (derived using CKD EPI)
- Persistent/permanent atrial fibrillation/flutter (conditions which significantly impede MRI image interpretability)
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- Acute coronary syndrome, stroke or surgery within 1 month (small type 2 MI in the context of acute HF does not apply)
- BMI >52 kg/m2
- Liver disease, defined by serum levels of alanine aminotransferase, aspartate aminotransferase, or alkaline phosphatase above 3 x upper limit of normal (ULN) during screening
- Bariatric surgery within the past two years and other gastrointestinal surgeries that induce chronic malabsorption
- Any condition outside the cardiovascular and renal disease area, such as but not limited to malignancy, with a life expectancy of less than 2 years based on investigator's clinical judgement
- Active malignancy requiring treatment at the time of visit 1 (with the exception of successfully treated basal cell or treated squamous cell carcinoma, adjuvant hormonal therapy for breast cancer and hormone therapy for prostate cancer)
- Blood dyscrasias or any disorders causing haemolysis or unstable red blood cells (e.g. malaria, babesiosis, haemolytic anaemia)
- Treatment with systemic steroids at time of informed consent or change in dosage of thyroid hormones within 6 weeks prior to informed consent
- Any uncontrolled endocrine disorder except Type 2 DM
- Alcohol or drug abuse within 3 months of informed consent that would interfere with trial participation or any ongoing condition leading to decreased compliance with study procedures or study drug intake
- Known hypersensitivity to the empagliflozin or excipients
- Known hypersensitivity to gadolinium
- Inability to give informed consent
- SGLT2 inhibitor use (current or previous)
- Devices or any other contraindication to MRI scans
- Currently pregnant, planning pregnancy, or currently breastfeeding
- History of previous lower limb amputation
- Current participation in another interventional medical study or within the last 90 days
- Anyone who, in the investigators' opinion, is not suitable to participate in the trial for other reasons
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Queen Elizabeth University Hospital
Glasgow, Scotland, G51 4TF
About this study
Official title: Studies of Empagliflozin and Its Cardiovascular, Renal and Metabolic Effects in Patients With Diabetes Mellitus (or Pre-diabetes) and Heart Failure (SUGAR-DM-HF)
The investigators hypothesise that empagliflozin 10mg daily will have haemodynamic, cardiac, and renal benefits compared to placebo over 36 weeks in heart failure patients with type 2 diabetes (or pre-diabetes), leading to measurable improvements in clinical measures of cardiac structure and function (LVESVI, and LV strain) as well as renal blood flow.
Read the detailed description
The results of the EMPA-REG OUTCOME trial on CVD outcomes and heart failure hospitalisation suggests that empagliflozin works quickly to lessen CVD mortality and reduce heart failure hospitalisations in patients with diabetes and existing cardiovascular disease. The lack of effect on non-fatal MI and stroke would suggest limited impact on atherothrombotic mechanisms. It is important to understand the mechanisms by which empagliflozin is acting in more detail, in order that the drug can be more widely targeted at patient groups that might benefit most; particularly patients with heart failure and diabetes (or pre-diabetes) (as discussed in the rationale).
The investigators have hypothesised, in a detailed published review, that the benefit derives from the specific effects of sodium-glucose linked transporter-2 (SGLT2) inhibition on renal sodium and glucose handling, leading to both diuresis and improvements in diabetes-related maladaptive renal arteriolar responses. These haemodynamic and renal effects are likely to be beneficial in patients with clinical or subclinical cardiac dysfunction. The net result of these processes is an improvement in cardiac systolic and diastolic function and, thereby, a lower risk of heart failure hospitalisation (HFH) and sudden cardiac death.
The investigators have therefore designed the present trial to perform a comprehensive clinical trial to interrogate in detail the effects of empagliflozin on specific pathways (inclusive of cardiac and renal effects) in patients with type 2 diabetes (or pre-diabetes) and heart failure.
- Conditions
- Heart Failure, Diabetes Mellitus
- Being tested
- Empagliflozin 10 MG, Placebo Oral Tablet
- Keywords
- heart failure, diabetes mellitus, empagliflozin, Randomised, placebo controlled trial
- Medical subject headings
- Heart Failure, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Empagliflozin 10 MGDrug
Empagliflozin 10mg tablets for oral self administration once a day
Placebo Oral TabletDrug
placebo tablets for oral self administration once a day
| Study group | Role | What they receive |
|---|---|---|
| Empagliflozin | Active comparator | Empagliflozin 10mg tablets for oral self-administration once daily Receives: Drug: Empagliflozin 10 MG |
| Placebo Oral Tablet | Placebo comparator | placebo tablets for oral self-administration once daily Receives: Drug: Placebo Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Left Ventricular End Systolic Volume Index (LVESVI)
Cardiac structure measured by left ventricular end-systolic volume index measured by cardiac magnetic resonance imaging as mL/m2
Measured: 36 weeks
left ventricular global longitudinal strain (GLS)
Cardiac structure measured by left ventricular global longitudinal strain measured by cardiac magnetic resonance imaging GLS%
Measured: 36 weeks
Secondary outcomes (16)
Left ventricular end diastolic volume index (LVEDVI)
Left ventricular end diastolic volume index (LVEDVI) measured by Cardiac MR in ml/m2
Measured: 36 weeks
Left ventricular ejection fraction (LVEF)
Left ventricular ejection fraction (LVEF) measured by Cardiac MR in percentage
Measured: 36 weeks
Left ventricular mass index (LVMI)
Left ventricular mass index (LVMI) measured by cardiac MR in grams/m2
Measured: 36 weeks
Left ventricular global function index (LVGFI)
Left ventricular global function index (LVGFI) measured by cardiac MR in percentage
Measured: 36 weeks
Left atrial volume index (LAVI)
Left atrial volume index (LAVI) measured by cardiac MR in ml/m2
Measured: 36 weeks
Microvascular perfusion
Microvascular perfusion measured by Gadolinium enhanced Cardiac magnetic resonance imaging measured as ml/min/g
Measured: 36 weeks
Extracellular volume fraction
Extracellular volume fraction measured by Gadolinium enhanced Cardiac magnetic resonance imaging measured as %
Measured: 36 weeks
Kansas City Cardiomyopathy Questionnaire (KCCQ) Total Symptom Score (TSS)
Kansas City Cardiomyopathy Questionnaire Total Symptom score (TSS) measured by mean overall difference and responder analysis (higher score = better outcome)
Measured: 36 weeks
6 minute walk distance (Exercise Capacity)
Exercise capacity measured by six minute walk test measured in m
Measured: 36 weeks
Pulmonary congestion
Pulmonary congestion as B-lines measured using lung ultrasound
Measured: 36 weeks
Biomarker profile -glycated haemaglobin (HbA1c)
biomarker profile of HbA1c (mmol/mol)
Measured: 36 weeks
Biomarker profile - creatine
biomarker profile of creatine (umol/L)
Measured: 36 weeks
Biomarker profile - estimated glomerular filtration rate (eGFR)
biomarker profile of eGFR (ml/min/m2)
Measured: 36 weeks
Biomarker profile - liver function tests (LFTs)
biomarker profile of LFTs (U/L)
Measured: 36 weeks
Biomarker profile - uric acid
biomarker profile of uric acid (umol/L)
Measured: 36 weeks
Intensification of diuretic therapy
Intensification of diuretic therapy through addition and/or increase dose of diuretic medication
Measured: 36 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2018
- Study start16 Mar 2018
- Primary completion28 Mar 2020
- Study completion28 Mar 2020
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised, placebo controlled trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- NHS Greater Glasgow and Clyde
- Sponsor type
- University, hospital or other
- Collaborators
- University of Glasgow
- Responsible party
- Sponsor
- Investigators
- Naveed Sattar, PhD, Study chair, Glasgow University and NHS GGC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03485092
- Sponsor's protocol ID
- GN15CA580
- Acronym
- SUGAR-DM-HF
- Status last verified
- Sep 2020
- First submitted
- 19 Mar 2018
- Last updated
- 18 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Zinman B, Wanner C, Lachin JM, Fitchett D, Bluhmki E, Hantel S, Mattheus M, Devins T, Johansen OE, Woerle HJ, Broedl UC, Inzucchi SE; EMPA-REG OUTCOME Investigators. Empagliflozin, Cardiovascular Outcomes, and Mortality in Type 2 Diabetes. N Engl J Med. 2015 Nov 26;373(22):2117-28. doi: 10.1056/NEJMoa1504720. Epub 2015 Sep 17.
PubMed 26378978Kanie T, Mizuno A, Takaoka Y, Suzuki T, Yoneoka D, Nishikawa Y, Tam WWS, Morze J, Rynkiewicz A, Xin Y, Wu O, Providencia R, Kwong JS. Dipeptidyl peptidase-4 inhibitors, glucagon-like peptide 1 receptor agonists and sodium-glucose co-transporter-2 inhibitors for people with cardiovascular disease: a network meta-analysis. Cochrane Database Syst Rev. 2021 Oct 25;10(10):CD013650. doi: 10.1002/14651858.CD013650.pub2.
PubMed 34693515Lee MMY, Brooksbank KJM, Wetherall K, Mangion K, Roditi G, Campbell RT, Berry C, Chong V, Coyle L, Docherty KF, Dreisbach JG, Labinjoh C, Lang NN, Lennie V, McConnachie A, Murphy CL, Petrie CJ, Petrie JR, Speirits IA, Sourbron S, Welsh P, Woodward R, Radjenovic A, Mark PB, McMurray JJV, Jhund PS, Petrie MC, Sattar N. Effect of Empagliflozin on Left Ventricular Volumes in Patients With Type 2 Diabetes, or Prediabetes, and Heart Failure With Reduced Ejection Fraction (SUGAR-DM-HF). Circulation. 2021 Feb 9;143(6):516-525. doi: 10.1161/CIRCULATIONAHA.120.052186. Epub 2020 Nov 13.
PubMed 33186500
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Studies of Empagliflozin and Its Cardiovascular, Renal and Metabolic Effects in Patients With Diabetes Mellitus (or Pre-diabetes) and Heart Failure (SUGAR-DM-HF)
- ClinicalTrials.gov ID
- NCT03485092
- Acronym / sponsor ID
- SUGAR-DM-HF / GN15CA580
- Conditions
- Heart Failure, Diabetes Mellitus
- Keywords
- heart failure, diabetes mellitus, empagliflozin, Randomised, placebo controlled trial
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- NHS Greater Glasgow and ClydeUniversity, hospital or other
- Collaborators
- University of Glasgow
- Study start
- 16 Mar 2018 (actual)
- Primary completion
- 28 Mar 2020 (actual)
- Study completion
- 28 Mar 2020 (actual)
- First posted
- 2 Apr 2018 (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 investigators hypothesise that empagliflozin 10mg daily will have haemodynamic, cardiac, and renal benefits compared to placebo over 36 weeks in heart failure patients with type 2 diabetes (or pre-diabetes), leading to measurable improvements in clinical measures of cardiac structure and function (LVESVI, and LV strain) as well as renal blood flow.
Detailed description
The results of the EMPA-REG OUTCOME trial on CVD outcomes and heart failure hospitalisation suggests that empagliflozin works quickly to lessen CVD mortality and reduce heart failure hospitalisations in patients with diabetes and existing cardiovascular disease. The lack of effect on non-fatal MI and stroke would suggest limited impact on atherothrombotic mechanisms. It is important to understand the mechanisms by which empagliflozin is acting in more detail, in order that the drug can be more widely targeted at patient groups that might benefit most; particularly patients with heart failure and diabetes (or pre-diabetes) (as discussed in the rationale).
The investigators have hypothesised, in a detailed published review, that the benefit derives from the specific effects of sodium-glucose linked transporter-2 (SGLT2) inhibition on renal sodium and glucose handling, leading to both diuresis and improvements in diabetes-related maladaptive renal arteriolar responses. These haemodynamic and renal effects are likely to be beneficial in patients with clinical or subclinical cardiac dysfunction. The net result of these processes is an improvement in cardiac systolic and diastolic function and, thereby, a lower risk of heart failure hospitalisation (HFH) and sudden cardiac death.
The investigators have therefore designed the present trial to perform a comprehensive clinical trial to interrogate in detail the effects of empagliflozin on specific pathways (inclusive of cardiac and renal effects) in patients with type 2 diabetes (or pre-diabetes) and heart failure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomised, placebo controlled trial
| Arm | Type | Receives |
|---|---|---|
| Empagliflozin | Active comparator | Drug: Empagliflozin 10 MGEmpagliflozin 10mg tablets for oral self-administration once daily |
| Placebo Oral Tablet | Placebo comparator | Drug: Placebo Oral Tabletplacebo tablets for oral self-administration once daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Written informed consent
- Male or female, aged ≥18 years age
- Type 2 DM (diet-controlled or on stable treatment) or prediabetes
- Heart failure (as defined by the presence of typical signs and symptoms of heart failure with documented reduced ejection fraction (ref SIGN and ESC guidelines))
- Women of childbearing potential (WOCBP) must be currently adhering to, or be willing to use, highly effective birth control methods for study treatment duration including:
Key exclusion criteria (25 listed)
- Type 1 DM
- History of hospital admission with a diagnosis of diabetic ketoacidosis (DKA)
- Insulin use within 1 year of diagnosis of diabetes
- History of acute or chronic pancreatitis
- eGFR <30 ml/min/1.73m2 (derived using CKD EPI)
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 |
|---|---|---|
| Empagliflozin 10 MGEmpagliflozin 10mg tablets for oral self administration once a day | Drug | Empagliflozin |
| Placebo Oral Tabletplacebo tablets for oral self administration once a day | Drug | Placebo Oral Tablet |
Primary outcome
Left Ventricular End Systolic Volume Index (LVESVI)
Time frame: 36 weeks
Cardiac structure measured by left ventricular end-systolic volume index measured by cardiac magnetic resonance imaging as mL/m2
left ventricular global longitudinal strain (GLS)
Time frame: 36 weeks
Cardiac structure measured by left ventricular global longitudinal strain measured by cardiac magnetic resonance imaging GLS%
16 secondary outcomes
Left ventricular end diastolic volume index (LVEDVI)
Time frame: 36 weeks
Left ventricular ejection fraction (LVEF)
Time frame: 36 weeks
Left ventricular mass index (LVMI)
Time frame: 36 weeks
Left ventricular global function index (LVGFI)
Time frame: 36 weeks
Left atrial volume index (LAVI)
Time frame: 36 weeks
Microvascular perfusion
Time frame: 36 weeks
Extracellular volume fraction
Time frame: 36 weeks
Kansas City Cardiomyopathy Questionnaire (KCCQ) Total Symptom Score (TSS)
Time frame: 36 weeks
6 minute walk distance (Exercise Capacity)
Time frame: 36 weeks
Pulmonary congestion
Time frame: 36 weeks
Biomarker profile -glycated haemaglobin (HbA1c)
Time frame: 36 weeks
Biomarker profile - creatine
Time frame: 36 weeks
Biomarker profile - estimated glomerular filtration rate (eGFR)
Time frame: 36 weeks
Biomarker profile - liver function tests (LFTs)
Time frame: 36 weeks
Biomarker profile - uric acid
Time frame: 36 weeks
Intensification of diuretic therapy
Time frame: 36 weeks
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 18 Sep 2020.
- Background: PubMed 26378978Zinman B, Wanner C, Lachin JM, Fitchett D, Bluhmki E, Hantel S, Mattheus M, Devins T, Johansen OE, Woerle HJ, Broedl UC, Inzucchi SE; EMPA-REG OUTCOME Investigators. Empagliflozin, Cardiovascular Outcomes, and Mortality in Type 2 Diabetes. N Engl J Med. 2015 Nov 26;373(22):2117-28. doi: 10.1056/NEJMoa1504720. Epub 2015 Sep 17.
- Derived from this study: PubMed 34693515Kanie T, Mizuno A, Takaoka Y, Suzuki T, Yoneoka D, Nishikawa Y, Tam WWS, Morze J, Rynkiewicz A, Xin Y, Wu O, Providencia R, Kwong JS. Dipeptidyl peptidase-4 inhibitors, glucagon-like peptide 1 receptor agonists and sodium-glucose co-transporter-2 inhibitors for people with cardiovascular disease: a network meta-analysis. Cochrane Database Syst Rev. 2021 Oct 25;10(10):CD013650. doi: 10.1002/14651858.CD013650.pub2.
- Derived from this study: PubMed 33186500Lee MMY, Brooksbank KJM, Wetherall K, Mangion K, Roditi G, Campbell RT, Berry C, Chong V, Coyle L, Docherty KF, Dreisbach JG, Labinjoh C, Lang NN, Lennie V, McConnachie A, Murphy CL, Petrie CJ, Petrie JR, Speirits IA, Sourbron S, Welsh P, Woodward R, Radjenovic A, Mark PB, McMurray JJV, Jhund PS, Petrie MC, Sattar N. Effect of Empagliflozin on Left Ventricular Volumes in Patients With Type 2 Diabetes, or Prediabetes, and Heart Failure With Reduced Ejection Fraction (SUGAR-DM-HF). Circulation. 2021 Feb 9;143(6):516-525. doi: 10.1161/CIRCULATIONAHA.120.052186. Epub 2020 Nov 13.
- Individual participant dataSharing planned: Undecided
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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.
Naveed Sattar, PhD study chair
Glasgow University and NHS GGC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Empagliflozin 10 MG in people with Heart Failure and Diabetes Mellitus, run by NHS Greater Glasgow and Clyde at 1 site in United Kingdom.
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 20 inclusion and 25 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 18 Sep 2020. 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 Kingdom. 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?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Left Ventricular End Systolic Volume Index (LVESVI) (time frame: 36 weeks). 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 NCT03485092, 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 18 Sep 2020.