Chronic Heart FailurePhase 2ELSINCT03128528
Analysing the Effect of Empagliflozin on Reduction of Tissue Sodium Content in Patients With Chronic Heart Failure
A Phase 2 study testing Empagliflozin 10mg in people with Chronic Heart Failure, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.
Trial summary
The hypothesis is that the SGLT-2 inhibitor empagliflozin reduces tissue sodium content in patients with chronic heart failure, and if the hypothesis is proven, that this mechanism contributes to the beneficial effects found in EMPA-REG Outcome trial potentially via exerting beneficial effects on the vascular… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Heart Failure
- What is being tested?
- Empagliflozin 10mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jul 2017to 30 Apr 2020
- Phase
- Phase 2
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age of 18 - 85 years
- Male and Female patients (females of child bearing potential must be using adequate contraceptive precautions)
- CHF (symptoms and/or sign of CHF, ejection fraction < 40% (HfrEF) 14 or symptoms and/or signs of CHF, ejection fraction 40-49 % and NT-pro BNP > 125 pg/ml, and at least one structural abnormality of left atrium or ventricle (HFmEF) 14 in stable conditions.
- Females of childbearing potential or within two years of the menopause must have a negative urine pregnancy test at screening visit.
- Informed consent has to be given in written form.
Who cannot join
- Any other form of diabetes mellitus than type 2 diabetes mellitus
- Use of insulin or any SGLT-2 inhibitor within the past 10 weeks prior to the screening visit (visit 1).
- Patients with more than two blood glucose lowering medications
- Uncontrolled diabetes (fasting plasma glucose ≥ 240 mg/dl, HbA1c ≥ 10%)
- Any history of stroke, transient ischemic attack, instable angina pectoris, or myocardial infarction within the last 6 months prior to study inclusion
- Estimated glomerular filtration rate (eGFR) < 30 ml/min/1.73m² (following the inclusion criteria of EMPA-REG OUTCOME study 1-3)
Show all 13Show fewer
- Chronic heart failure NYHA stage IV
- Use of loop diuretics above furosemide > 80 mg/day, or torasemide >40 mg/day, or piretanide > 6 mg/day
- Implanted pacemakers or defibrillators
- Any other relevant clinical contraindication of MRI examination
- Uncontrolled arterial hypertension (i.e. ≥ 180/110 mmHg)
- Severe disorders of the gastrointestinal tract or other diseases which interfere with the pharmacodynamics and pharmacokinetics of study drugs
- Significant laboratory abnormalities such as Serum Glutamate-Oxaloacetate-Transaminase (SGOT) or Serum Glutamate-Pyruvate-Transaminase (SGPT) levels more than 3 x above the upper limit of normal range
Trial locations and contacts
1 site in 1 country.
Germany1 site
Clinical Research Center, Department of Nephrology and Hypertension, University of Erlangen-Nuremberg
Erlangen, 91054
About this study
Official title: Randomized, Double-blind, Placebo Controlled, Parallel-group, Prospective Clinical Study to Analyse the Effect of Empagliflozin on Reduction of Tissue Sodium Content in Patients With Chronic Heart Failure
The hypothesis is that the SGLT-2 inhibitor empagliflozin reduces tissue sodium content in patients with chronic heart failure, and if the hypothesis is proven, that this mechanism contributes to the beneficial effects found in EMPA-REG Outcome trial potentially via exerting beneficial effects on the vascular structure and function of the micro- and macrocirculation.
Read the detailed description
SGLT-2 inhibitors such as empagliflozin inhibit the SGLT-2 transport in the proximal tubular cells of the kidney, thereby causing glucosuria to approximately 100 g per day (and sometimes even more). The SGLT-2 inhibition does not only cause glucosuria but also natriuresis, since with each molecule of glucose one molecule of sodium is inhibited to be reabsorbed. Indeed, during the first week SGLT-2 inhibition causes clinically detectable natriuresis but its effect in the long run is not yet illustrated. Of course, a new sodium balance will be achieved after a certain time (otherwise the human body would be completely salt depleted), but total sodium content could be different. With new innovative magnetic resonance imaging (MRI) technology we are able to assess tissue sodium content in the skin and muscle, and observed that sodium content is significantly increased with aging, severe hypertension or hyperaldosteronism. Furthermore, skin sodium content assessed by MRI was closely related to left ventricular mass (r=0.559, p<0.0001, N=89) independently of age, gender, body mass index, and 24 h ambulatory blood pressure (β=0.343, p=0.001, N=89) 11. Using this technology, our first yet unpublished data (clinicaltrials.gov: NCT02383238) indicate that SGLT-2 inhibition decreases sodium content in the skin in patients with diabetes. Finally, we observed previously that in patients with acute chronic heart failure skin sodium content decreased from 43.5 mmol/l to 32.2 mmol/l after diuretic therapy.
Thus, the present study aims at analyzing changes in total and tissue sodium content after SGLT-2 inhibition with empagliflozin. In parallel, sodium intake and excretion and central systolic and pulse pressure as well as other vascular parameters will be assessed. In face of the upcoming studies with empagliflozin conducted in patients with reduced and preserved ejection fraction (two large-scale, prospective, doubleblind, placebo controlled studies planned by Boehringer Ingelheim as the sponsor), we thought that we focus on patients with chronic heart failure irrespective diabetic status. The hypothesis is that the SGLT-2 inhibitor empagliflozin reduces tissue sodium content in patients with chronic heart failure, and if the hypothesis is proven, that this mechanism contributes to the beneficial effects found in EMPA-REG Outcome trial potentially via exerting beneficial effects on the vascular structure and function of the micro- and macrocirculation.
- Conditions
- Chronic Heart Failure
- Being tested
- Empagliflozin 10mg, Placebo Oral Tablet
- Keywords
- SGLT-2 inhibitor, Chronic heart failure, tissue sodium,
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Empagliflozin 10mgDrug
Also called EMPA
Each patient, after the run-in/wash-out phase, will be randomly assigned in a doubleblind fashion to one of the two treatment sequences according to a randomisation list.
and provided by the sponsor.
Placebo Oral TabletDrug
Also called PLACEBO
Each patient, after the run-in/wash-out phase, will be randomly assigned in a doubleblind fashion to one of the two treatment sequences according to a randomisation list.
and provided by the sponsor.
| Study group | Role | What they receive |
|---|---|---|
| Placebo Oral Tablet | Placebo comparator | Patients will be randomized to empagliflozin 10 mg orally once daily or one placebo tablet orally once daily. Receives: Drug: Placebo Oral Tablet |
| Empagliflozin | Active comparator | Patients will be randomized to empagliflozin 10 mg orally once daily or one placebo tablet orally once daily. Receives: Drug: Empagliflozin 10mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skin sodium content
Skin sodium content (23Na-MRI) assessed at the lower leg
Measured: 14 weeks
Secondary outcomes (13)
Muscle sodium content
Sodium content of muscles
Measured: 14 weeks
Water content of skin and muscle
Water content (1H) of skin and muscle
Measured: 14 weeks
Sodium excretion
Sodium excretion as assessed by sodium creatinine ratio in spot urine
Measured: 14 weeks
24-hour urine sodium excretion
24-hour urine sodium excretion
Measured: 14 weeks
Vascular stiffness Parameter (central systolic pressure)
Vascular stiffness Parameter under resting conditions and ambulatory conditions and their association to change in tissue sodium content
Measured: 14 weeks
Flow mediated vasodilation
Flow mediated vasodilation (FMD) as measured by semiautomated ultrasound system
Measured: 14 weeks
N-terminal prohormone of brain natriuretic peptide
N-terminal prohormone of brain natriuretic peptide (NT-pro-BNP) to assess their relation to change in tissue sodium content
Measured: 14 weeks
Body weight
Measurement of body weight in kg
Measured: 14 weeks
HbA1c
Diabetic control (e.g. fasting glucose, glycosylated hemoglobin [HbA1c])
Measured: 14 weeks
ABPM
24-hour ambulatory blood pressure (ABP)
Measured: 14 weeks
Visual analogue scale for dyspnea
Visual analogue scale for dyspnea to assess their relation to change in tissue sodium Content.
Measured: 14 weeks
Body constitution
Body constitution (fluid status based on three compartment model lean body mass, adipose tissue mass and overhydration)
Measured: 14 weeks
Vascular stiffness Parameter (Pulse pressure)
Vascular stiffness Parameter under resting conditions and ambulatory conditions and their association to change in tissue sodium content
Measured: 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2017
- Study start1 Jul 2017
- Primary completion31 Jan 2020
- Study completion30 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Chronic Heart FailureStudies of the same condition, open and under way.
- More trials run by University of Erlangen-Nürnberg Medical SchoolThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Phase II, randomized (2:1), prospective, double-blind, placebo controlled, parallel-group, single center study.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Erlangen-Nürnberg Medical School
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Roland E Schmieder, Prof. Dr., Principal investigator, University of Erlangen-Nürnberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03128528
- Sponsor's protocol ID
- CRC2017ELSI
- Acronym
- ELSI
- Status last verified
- Sep 2020
- First submitted
- 3 Apr 2017
- Last updated
- 28 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Striepe K, Jumar A, Ott C, Karg MV, Schneider MP, Kannenkeril D, Schmieder RE. Effects of the Selective Sodium-Glucose Cotransporter 2 Inhibitor Empagliflozin on Vascular Function and Central Hemodynamics in Patients With Type 2 Diabetes Mellitus. Circulation. 2017 Sep 19;136(12):1167-1169. doi: 10.1161/CIRCULATIONAHA.117.029529. No abstract available.
PubMed 28923906Bytyqi V, Kannenkeril D, Kolwelter J, Linz P, Bosch A, Striepe K, Karg MV, Nagel AM, Uder M, Schiffer M, Achenbach S, Schmieder RE. Short- and mid-term effects of empagliflozin on sodium balance and fluid regulation in chronic heart failure. Eur J Heart Fail. 2025 Dec;27(12):3134-3141. doi: 10.1002/ejhf.70078. Epub 2025 Nov 4.
PubMed 41186108Kolwelter J, Kannenkeril D, Linz P, Jung S, Nagel AM, Bosch A, Ott C, Bramlage P, Noh L, Schiffer M, Uder M, Achenbach S, Schmieder RE. The SGLT2 inhibitor empagliflozin reduces tissue sodium content in patients with chronic heart failure: results from a placebo-controlled randomised trial. Clin Res Cardiol. 2023 Jan;112(1):134-144. doi: 10.1007/s00392-022-02119-7. Epub 2022 Oct 26.
PubMed 36289063Pietschner R, Kolwelter J, Bosch A, Striepe K, Jung S, Kannenkeril D, Ott C, Schiffer M, Achenbach S, Schmieder RE. Effect of empagliflozin on ketone bodies in patients with stable chronic heart failure. Cardiovasc Diabetol. 2021 Nov 9;20(1):219. doi: 10.1186/s12933-021-01410-7.
PubMed 34753480
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-blind, Placebo Controlled, Parallel-group, Prospective Clinical Study to Analyse the Effect of Empagliflozin on Reduction of Tissue Sodium Content in Patients With Chronic Heart Failure
- ClinicalTrials.gov ID
- NCT03128528
- Acronym / sponsor ID
- ELSI / CRC2017ELSI
- Conditions
- Chronic Heart Failure
- Keywords
- SGLT-2 inhibitor, Chronic heart failure, tissue sodium,
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- University of Erlangen-Nürnberg Medical SchoolUniversity, hospital or other
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 31 Jan 2020 (actual)
- Study completion
- 30 Apr 2020 (actual)
- First posted
- 25 Apr 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 hypothesis is that the SGLT-2 inhibitor empagliflozin reduces tissue sodium content in patients with chronic heart failure, and if the hypothesis is proven, that this mechanism contributes to the beneficial effects found in EMPA-REG Outcome trial potentially via exerting beneficial effects on the vascular structure and function of the micro- and macrocirculation.
Detailed description
SGLT-2 inhibitors such as empagliflozin inhibit the SGLT-2 transport in the proximal tubular cells of the kidney, thereby causing glucosuria to approximately 100 g per day (and sometimes even more). The SGLT-2 inhibition does not only cause glucosuria but also natriuresis, since with each molecule of glucose one molecule of sodium is inhibited to be reabsorbed. Indeed, during the first week SGLT-2 inhibition causes clinically detectable natriuresis but its effect in the long run is not yet illustrated. Of course, a new sodium balance will be achieved after a certain time (otherwise the human body would be completely salt depleted), but total sodium content could be different. With new innovative magnetic resonance imaging (MRI) technology we are able to assess tissue sodium content in the skin and muscle, and observed that sodium content is significantly increased with aging, severe hypertension or hyperaldosteronism. Furthermore, skin sodium content assessed by MRI was closely related to left ventricular mass (r=0.559, p<0.0001, N=89) independently of age, gender, body mass index, and 24 h ambulatory blood pressure (β=0.343, p=0.001, N=89) 11. Using this technology, our first yet unpublished data (clinicaltrials.gov: NCT02383238) indicate that SGLT-2 inhibition decreases sodium content in the skin in patients with diabetes. Finally, we observed previously that in patients with acute chronic heart failure skin sodium content decreased from 43.5 mmol/l to 32.2 mmol/l after diuretic therapy.
Thus, the present study aims at analyzing changes in total and tissue sodium content after SGLT-2 inhibition with empagliflozin. In parallel, sodium intake and excretion and central systolic and pulse pressure as well as other vascular parameters will be assessed. In face of the upcoming studies with empagliflozin conducted in patients with reduced and preserved ejection fraction (two large-scale, prospective, doubleblind, placebo controlled studies planned by Boehringer Ingelheim as the sponsor), we thought that we focus on patients with chronic heart failure irrespective diabetic status. The hypothesis is that the SGLT-2 inhibitor empagliflozin reduces tissue sodium content in patients with chronic heart failure, and if the hypothesis is proven, that this mechanism contributes to the beneficial effects found in EMPA-REG Outcome trial potentially via exerting beneficial effects on the vascular structure and function of the micro- and macrocirculation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Phase II, randomized (2:1), prospective, double-blind, placebo controlled, parallel-group, single center study.
| Arm | Type | Receives |
|---|---|---|
| Placebo Oral Tablet | Placebo comparator | Drug: Placebo Oral TabletPatients will be randomized to empagliflozin 10 mg orally once daily or one placebo tablet orally once daily. |
| Empagliflozin | Active comparator | Drug: Empagliflozin 10mgPatients will be randomized to empagliflozin 10 mg orally once daily or one placebo tablet orally once daily. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age of 18 - 85 years
- Male and Female patients (females of child bearing potential must be using adequate contraceptive precautions)
- CHF (symptoms and/or sign of CHF, ejection fraction < 40% (HfrEF) 14 or symptoms and/or signs of CHF, ejection fraction 40-49 % and NT-pro BNP > 125 pg/ml, and at least one structural abnormality of left atrium or ventricle (HFmEF) 14 in stable conditions.
- Females of childbearing potential or within two years of the menopause must have a negative urine pregnancy test at screening visit.
- Informed consent has to be given in written form.
Key exclusion criteria (13 listed)
- Any other form of diabetes mellitus than type 2 diabetes mellitus
- Use of insulin or any SGLT-2 inhibitor within the past 10 weeks prior to the screening visit (visit 1).
- Patients with more than two blood glucose lowering medications
- Uncontrolled diabetes (fasting plasma glucose ≥ 240 mg/dl, HbA1c ≥ 10%)
- Any history of stroke, transient ischemic attack, instable angina pectoris, or myocardial infarction within the last 6 months prior to study inclusion
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 10mgAlso: EMPAEach patient, after the run-in/wash-out phase, will be randomly assigned in a doubleblind fashion to one of the two treatment sequences according to a randomisation list. and provided by the sponsor. | Drug | Empagliflozin |
| Placebo Oral TabletAlso: PLACEBOEach patient, after the run-in/wash-out phase, will be randomly assigned in a doubleblind fashion to one of the two treatment sequences according to a randomisation list. and provided by the sponsor. | Drug | Placebo Oral Tablet |
Primary outcome
Skin sodium content
Time frame: 14 weeks
Skin sodium content (23Na-MRI) assessed at the lower leg
13 secondary outcomes
Muscle sodium content
Time frame: 14 weeks
Water content of skin and muscle
Time frame: 14 weeks
Sodium excretion
Time frame: 14 weeks
24-hour urine sodium excretion
Time frame: 14 weeks
Vascular stiffness Parameter (central systolic pressure)
Time frame: 14 weeks
Flow mediated vasodilation
Time frame: 14 weeks
N-terminal prohormone of brain natriuretic peptide
Time frame: 14 weeks
Body weight
Time frame: 14 weeks
HbA1c
Time frame: 14 weeks
ABPM
Time frame: 14 weeks
Visual analogue scale for dyspnea
Time frame: 14 weeks
Body constitution
Time frame: 14 weeks
Vascular stiffness Parameter (Pulse pressure)
Time frame: 14 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 28 Sep 2020.
- Background: PubMed 28923906Striepe K, Jumar A, Ott C, Karg MV, Schneider MP, Kannenkeril D, Schmieder RE. Effects of the Selective Sodium-Glucose Cotransporter 2 Inhibitor Empagliflozin on Vascular Function and Central Hemodynamics in Patients With Type 2 Diabetes Mellitus. Circulation. 2017 Sep 19;136(12):1167-1169. doi: 10.1161/CIRCULATIONAHA.117.029529. No abstract available.
- Derived from this study: PubMed 41186108Bytyqi V, Kannenkeril D, Kolwelter J, Linz P, Bosch A, Striepe K, Karg MV, Nagel AM, Uder M, Schiffer M, Achenbach S, Schmieder RE. Short- and mid-term effects of empagliflozin on sodium balance and fluid regulation in chronic heart failure. Eur J Heart Fail. 2025 Dec;27(12):3134-3141. doi: 10.1002/ejhf.70078. Epub 2025 Nov 4.
- Derived from this study: PubMed 36289063Kolwelter J, Kannenkeril D, Linz P, Jung S, Nagel AM, Bosch A, Ott C, Bramlage P, Noh L, Schiffer M, Uder M, Achenbach S, Schmieder RE. The SGLT2 inhibitor empagliflozin reduces tissue sodium content in patients with chronic heart failure: results from a placebo-controlled randomised trial. Clin Res Cardiol. 2023 Jan;112(1):134-144. doi: 10.1007/s00392-022-02119-7. Epub 2022 Oct 26.
- Derived from this study: PubMed 34753480Pietschner R, Kolwelter J, Bosch A, Striepe K, Jung S, Kannenkeril D, Ott C, Schiffer M, Achenbach S, Schmieder RE. Effect of empagliflozin on ketone bodies in patients with stable chronic heart failure. Cardiovasc Diabetol. 2021 Nov 9;20(1):219. doi: 10.1186/s12933-021-01410-7.
- Individual participant dataSharing planned: No
Related trials for Chronic Heart Failure
Not yet recruiting
RELIEVE-HFrEF TRIAL: REducing Lung congestIon Symptoms Using the v-wavE Shunt in adVancEd Heart Failure With Reduced EF
Heart Failure and Reduced Ejection Fraction, Heart Failure Chronic
Not yet recruiting
Community Health Worker Nutrition Self-Management Support for Cardio-Kidney-Metabolic Health
Hypertension (HTN), CKD - Chronic Kidney Disease
RecruitingPhase 4
The Effects of Low-Dose Versus High-Dose Intravenous IRON Therapy With Ferric DerisomaltOSE in Patients With Chronic Heart Failure and Iron Deficiency
Heart Failure, Iron Deficiency
Recruiting
WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
RecruitingObservational study
Norepinephrine in the Management of General Anesthesia-Induced Arterial Hypotension in Chronic Heart Failure Patients
Hypotension
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.
Roland E Schmieder, Prof. Dr. principal investigator
University of Erlangen-Nürnberg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Empagliflozin 10mg in people with Chronic Heart Failure, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.
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 5 inclusion and 13 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 28 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 Germany. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Skin sodium content (time frame: 14 weeks). 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 NCT03128528, which also lists 4 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 28 Sep 2020.