Heart Failure With Reduced Ejection FractionPhase 2Empire HFNCT03198585
Empagliflozin in Heart Failure Patients With Reduced Ejection Fraction
A Phase 2 study testing Empagliflozin 10 MG in people with Heart Failure With Reduced Ejection Fraction, run by Morten Schou at 2 sites in Denmark.
Trial summary
To assess the effect of Empagliflozin on cardiac biomarkers, cardiac function at rest and during stress, cardiac hemodynamics, renal function, metabolism, daily activity level and health-related quality of life in stable, symptomatic heart failure patients with reduced left ventricular ejection fraction. 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
- 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
- 190 participants
- Where
- 2 sitesDenmark
- Study dates
- 29 Jun 2017to 17 Jan 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Optimal Heart Failure Therapy in accordance with European and National Guidelines
- LVEF ≤ 0.40
- eGFR > 30 ml/min/1.73 m2
- BMI < 45 kg/m2
- NYHA class I-III
- Age > 18 years
Show all 9Show fewer
- If T2D - optimal treatment in accordance with European and National Guidelines
- If T2D - stable doses of antiglycemic treatment for 30 days
- If T2D - HbA1C 6.5-10%
Who cannot join
- CRT-D/-P implanted < 90 days
- Uncorrected severe valvular disease
- Non-compliance
- Use of metalozone
- NYHA IV
- Age > 85 years
Show all 16Show fewer
- Dementia
- Admission for HF < 30 days
- Admission for hypoglycemia < 12 month
- Known sustained VT
- Symptomatic hypotension and systolic BP < 95 mmHg
- Unable to perform an exercise test
- Immobilization
- Pregnancy
- Participation in other medical trials
- Previous intolerance of Empagliflozin or excipients
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Herlev and Gentofte University Hospital
Copenhagen, 2730
Odense University Hospital
Odense, 5000
About this study
Official title: Empagliflozin in Heart Failure Patients With Reduced Ejection Fraction: A Randomized Clinical Trial (Empire HF)
To assess the effect of Empagliflozin on cardiac biomarkers, cardiac function at rest and during stress, cardiac hemodynamics, renal function, metabolism, daily activity level and health-related quality of life in stable, symptomatic heart failure patients with reduced left ventricular ejection fraction.
The primary hypothesis is that 3 months' treatment with Empagliflozin 10 mg a day will reduce the plasma concentrations of N-terminal pro-brain natriuretic peptide (NT-proBNP).
- Being tested
- Empagliflozin 10 MG, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Empagliflozin 10 MGDrug
Capsule, once a day for 90 days
PlaceboOther
Capsule, once a day for 90 days
| Study group | Role | What they receive |
|---|---|---|
| Empagliflozin 10 mg | Active comparator | Not described Receives: Drug: Empagliflozin 10 MG |
| Placebo | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Between-group difference in the change of plasma concentrations of NT-proBNP
Measured: 90 days
Secondary outcomes (15)
Between-group difference in the change in daily activity level measured by patient-worn accelerometers as change in the amount of daily average accelerometer units
Measured: 90 days
Between-group difference in the change in body composition assessed by DXA scan
Measured: 90 days
Between-group difference in the change of estimated extracellular volume assessed by Cr-51 EDTA clearance
Measured: 90 days
Between-group difference in the change of estimated plasma volume assessed by hematocrit and hemoglobin
Measured: 90 days
Between-group difference in the change of glucose metabolism assessed by oral glucose tolerance test
Measured: 90 days
Between-group difference in the change of ketone supply to the heart assessed by blood ketones
Measured: 90 days
Between-group difference in the change of renal function assessed by Cr-51 EDTA clearance
Measured: 90 days
Between-group difference in the change of uric acid
Measured: 90 days
Between-group difference in the change of urine albumin/creatinine ratio
Measured: 90 days
Between-group difference in the change of cardiac biomarkers assessed by plasma concentrations of MR-proADM and hs-cTnI
Measured: 90 days
Between-group difference in the change of cardiac systolic and diastolic function including left ventricular global longitudinal strain and left ventricular ejection fraction assessed by transthoracic echocardiography at rest and during stress
Measured: 90 days
Between-group difference in the change of cardiac hemodynamics during rest and sub-maximal exercise assessed by right heart catheterization including pulmonary capillary wedge pressure to cardiac index ratio
Measured: 90 days
Between-group difference in the change of cardiac hemodynamics during rest and sub-maximal exercise assessed by right heart catheterization including left ventricular contractile reserve
Measured: 90 days
Between-group difference in the change of health-related quality of life assessed by the questionnaire KCCQ
Measured: 90 days
Between-group difference in the change of health-related quality of life assessed by the questionnaire EQ-5D-5L
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2017
- Study start29 Jun 2017
- Primary completion20 Dec 2019
- Study completion17 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 190 participants (actual)
Sponsor and investigators
- Lead sponsor
- Morten Schou
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Morten Schou, Herlev and Gentofte Hospital
- Investigators
- Morten Schou, MD, Principal investigator, Herlev and Gentofte University HospitalJacob E Moller, MD, Principal investigator, Odense University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03198585
- Sponsor's protocol ID
- Empire HF
- Other IDs
- 2017-001341-27, 2017
- Acronym
- Empire HF
- Status last verified
- Jan 2020
- First submitted
- 21 Jun 2017
- Last updated
- 5 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Omar M, Jensen J, Ali M, Frederiksen PH, Kistorp C, Videbaek L, Poulsen MK, Tuxen CD, Borlaug BA, Moller S, Gustafsson F, Kober L, Schou M, Moller JE. Effects of empagliflozin on right ventricular free-wall strain in patients with heart failure and reduced ejection fraction: results from the Empire HF Trial. ESC Heart Fail. 2026 May 5;13(3):xvaf031. doi: 10.1093/eschf/xvaf031.
PubMed 41711194Omar M, Jensen J, Frederiksen PH, Ali M, Kistorp C, Videbaek L, Poulsen MK, Tuxen CD, Borlaug BA, Moller S, Gustafsson F, Kober L, Schou M, Moller JE. Effects of Empagliflozin on Right Ventricular Function in Heart Failure with Reduced Ejection Fraction. medRxiv [Preprint]. 2025 Jun 2:2025.05.30.25328686. doi: 10.1101/2025.05.30.25328686.
PubMed 40502611Emanuelsson F, Jensen J, Omar M, Jurgens M, Kistorp C, Brandt-Jacobsen NH, Moller JE, Schou M, Bechmann LE, Larsen EL, Nordestgaard BG, Benn M. Effect of empagliflozin on plasma lipids and lipoproteins in type 2 diabetes and heart failure - Empire HF and SIMPLE. J Clin Lipidol. 2025 Mar-Apr;19(2):276-285. doi: 10.1016/j.jacl.2024.12.015. Epub 2024 Dec 21.
PubMed 39843293Jensen J, Omar M, Kistorp C, Tuxen C, Poulsen MK, Faber J, Kober L, Gustafsson F, Moller JE, Schou M. Effect of Empagliflozin on Multiple Biomarkers in Heart Failure: Insights From the Empire Heart Failure Trial. Circ Heart Fail. 2022 Aug;15(8):e009333. doi: 10.1161/CIRCHEARTFAILURE.121.009333. Epub 2022 Apr 21. No abstract available.
PubMed 35973031Omar M, Jensen J, Kistorp C, Hojlund K, Videbaek L, Tuxen C, Larsen JH, Andersen CF, Gustafsson F, Kober L, Schou M, Moller JE. The effect of empagliflozin on growth differentiation factor 15 in patients with heart failure: a randomized controlled trial (Empire HF Biomarker). Cardiovasc Diabetol. 2022 Feb 27;21(1):34. doi: 10.1186/s12933-022-01463-2.
PubMed 35219331Omar M, Jensen J, Burkhoff D, Frederiksen PH, Kistorp C, Videbaek L, Poulsen MK, Gustafsson F, Kober L, Borlaug BA, Schou M, Moller JE. Effect of Empagliflozin on Blood Volume Redistribution in Patients With Chronic Heart Failure and Reduced Ejection Fraction: An Analysis From the Empire HF Randomized Clinical Trial. Circ Heart Fail. 2022 Mar;15(3):e009156. doi: 10.1161/CIRCHEARTFAILURE.121.009156. Epub 2021 Nov 8.
PubMed 34743533Omar M, Jensen J, Frederiksen PH, Videbaek L, Poulsen MK, Brond JC, Gustafsson F, Borlaug BA, Schou M, Moller JE. Hemodynamic Determinants of Activity Measured by Accelerometer in Patients With Stable Heart Failure. JACC Heart Fail. 2021 Nov;9(11):824-835. doi: 10.1016/j.jchf.2021.05.013. Epub 2021 Sep 8.
PubMed 34509409Jensen J, Omar M, Kistorp C, Tuxen C, Gustafsson I, Kober L, Gustafsson F, Faber J, Forman JL, Moller JE, Schou M. Metabolic Effects of Empagliflozin in Heart Failure: A Randomized, Double-Blind, and Placebo-Controlled Trial (Empire HF Metabolic). Circulation. 2021 Jun;143(22):2208-2210. doi: 10.1161/CIRCULATIONAHA.120.053463. Epub 2021 Jun 1. No abstract available.
PubMed 34061581Omar M, Jensen J, Ali M, Frederiksen PH, Kistorp C, Videbaek L, Poulsen MK, Tuxen CD, Moller S, Gustafsson F, Kober L, Schou M, Moller JE. Associations of Empagliflozin With Left Ventricular Volumes, Mass, and Function in Patients With Heart Failure and Reduced Ejection Fraction: A Substudy of the Empire HF Randomized Clinical Trial. JAMA Cardiol. 2021 Jul 1;6(7):836-840. doi: 10.1001/jamacardio.2020.6827.
PubMed 33404637Jensen J, Omar M, Kistorp C, Tuxen C, Gustafsson I, Kober L, Gustafsson F, Faber J, Malik ME, Fosbol EL, Bruun NE, Forman JL, Jensen LT, Moller JE, Schou M. Effects of empagliflozin on estimated extracellular volume, estimated plasma volume, and measured glomerular filtration rate in patients with heart failure (Empire HF Renal): a prespecified substudy of a double-blind, randomised, placebo-controlled trial. Lancet Diabetes Endocrinol. 2021 Feb;9(2):106-116. doi: 10.1016/S2213-8587(20)30382-X. Epub 2020 Dec 22.
PubMed 33357505Jensen J, Omar M, Kistorp C, Poulsen MK, Tuxen C, Gustafsson I, Kober L, Gustafsson F, Fosbol E, Bruun NE, Videbaek L, Frederiksen PH, Moller JE, Schou M. Empagliflozin in heart failure patients with reduced ejection fraction: a randomized clinical trial (Empire HF). Trials. 2019 Jun 21;20(1):374. doi: 10.1186/s13063-019-3474-5.
PubMed 31227014
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Empagliflozin in Heart Failure Patients With Reduced Ejection Fraction: A Randomized Clinical Trial (Empire HF)
- ClinicalTrials.gov ID
- NCT03198585
- Acronym / sponsor ID
- Empire HF / Empire HF
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 190 participants (actual)
- Lead sponsor
- Morten SchouUniversity, hospital or other
- Study start
- 29 Jun 2017 (actual)
- Primary completion
- 20 Dec 2019 (actual)
- Study completion
- 17 Jan 2020 (actual)
- First posted
- 26 Jun 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.
To assess the effect of Empagliflozin on cardiac biomarkers, cardiac function at rest and during stress, cardiac hemodynamics, renal function, metabolism, daily activity level and health-related quality of life in stable, symptomatic heart failure patients with reduced left ventricular ejection fraction.
The primary hypothesis is that 3 months' treatment with Empagliflozin 10 mg a day will reduce the plasma concentrations of N-terminal pro-brain natriuretic peptide (NT-proBNP).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Empagliflozin 10 mg | Active comparator | Drug: Empagliflozin 10 MG |
| Placebo | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Optimal Heart Failure Therapy in accordance with European and National Guidelines
- LVEF ≤ 0.40
- eGFR > 30 ml/min/1.73 m2
- BMI < 45 kg/m2
- NYHA class I-III
Key exclusion criteria (16 listed)
- CRT-D/-P implanted < 90 days
- Uncorrected severe valvular disease
- Non-compliance
- Use of metalozone
- NYHA IV
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 MGCapsule, once a day for 90 days | Drug | Empagliflozin 10 mg |
| PlaceboCapsule, once a day for 90 days | Other | Placebo |
Primary outcome
Between-group difference in the change of plasma concentrations of NT-proBNP
Time frame: 90 days
15 secondary outcomes
Between-group difference in the change in daily activity level measured by patient-worn accelerometers as change in the amount of daily average accelerometer units
Time frame: 90 days
Between-group difference in the change in body composition assessed by DXA scan
Time frame: 90 days
Between-group difference in the change of estimated extracellular volume assessed by Cr-51 EDTA clearance
Time frame: 90 days
Between-group difference in the change of estimated plasma volume assessed by hematocrit and hemoglobin
Time frame: 90 days
Between-group difference in the change of glucose metabolism assessed by oral glucose tolerance test
Time frame: 90 days
Between-group difference in the change of ketone supply to the heart assessed by blood ketones
Time frame: 90 days
Between-group difference in the change of renal function assessed by Cr-51 EDTA clearance
Time frame: 90 days
Between-group difference in the change of uric acid
Time frame: 90 days
Between-group difference in the change of urine albumin/creatinine ratio
Time frame: 90 days
Between-group difference in the change of cardiac biomarkers assessed by plasma concentrations of MR-proADM and hs-cTnI
Time frame: 90 days
Between-group difference in the change of cardiac systolic and diastolic function including left ventricular global longitudinal strain and left ventricular ejection fraction assessed by transthoracic echocardiography at rest and during stress
Time frame: 90 days
Between-group difference in the change of cardiac hemodynamics during rest and sub-maximal exercise assessed by right heart catheterization including pulmonary capillary wedge pressure to cardiac index ratio
Time frame: 90 days
Between-group difference in the change of cardiac hemodynamics during rest and sub-maximal exercise assessed by right heart catheterization including left ventricular contractile reserve
Time frame: 90 days
Between-group difference in the change of health-related quality of life assessed by the questionnaire KCCQ
Time frame: 90 days
Between-group difference in the change of health-related quality of life assessed by the questionnaire EQ-5D-5L
Time frame: 90 days
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 5 Feb 2020.
- Derived from this study: PubMed 41711194Omar M, Jensen J, Ali M, Frederiksen PH, Kistorp C, Videbaek L, Poulsen MK, Tuxen CD, Borlaug BA, Moller S, Gustafsson F, Kober L, Schou M, Moller JE. Effects of empagliflozin on right ventricular free-wall strain in patients with heart failure and reduced ejection fraction: results from the Empire HF Trial. ESC Heart Fail. 2026 May 5;13(3):xvaf031. doi: 10.1093/eschf/xvaf031.
- Derived from this study: PubMed 40502611Omar M, Jensen J, Frederiksen PH, Ali M, Kistorp C, Videbaek L, Poulsen MK, Tuxen CD, Borlaug BA, Moller S, Gustafsson F, Kober L, Schou M, Moller JE. Effects of Empagliflozin on Right Ventricular Function in Heart Failure with Reduced Ejection Fraction. medRxiv [Preprint]. 2025 Jun 2:2025.05.30.25328686. doi: 10.1101/2025.05.30.25328686.
- Derived from this study: PubMed 39843293Emanuelsson F, Jensen J, Omar M, Jurgens M, Kistorp C, Brandt-Jacobsen NH, Moller JE, Schou M, Bechmann LE, Larsen EL, Nordestgaard BG, Benn M. Effect of empagliflozin on plasma lipids and lipoproteins in type 2 diabetes and heart failure - Empire HF and SIMPLE. J Clin Lipidol. 2025 Mar-Apr;19(2):276-285. doi: 10.1016/j.jacl.2024.12.015. Epub 2024 Dec 21.
- Derived from this study: PubMed 35973031Jensen J, Omar M, Kistorp C, Tuxen C, Poulsen MK, Faber J, Kober L, Gustafsson F, Moller JE, Schou M. Effect of Empagliflozin on Multiple Biomarkers in Heart Failure: Insights From the Empire Heart Failure Trial. Circ Heart Fail. 2022 Aug;15(8):e009333. doi: 10.1161/CIRCHEARTFAILURE.121.009333. Epub 2022 Apr 21. No abstract available.
- Derived from this study: PubMed 35219331Omar M, Jensen J, Kistorp C, Hojlund K, Videbaek L, Tuxen C, Larsen JH, Andersen CF, Gustafsson F, Kober L, Schou M, Moller JE. The effect of empagliflozin on growth differentiation factor 15 in patients with heart failure: a randomized controlled trial (Empire HF Biomarker). Cardiovasc Diabetol. 2022 Feb 27;21(1):34. doi: 10.1186/s12933-022-01463-2.
- Derived from this study: PubMed 34743533Omar M, Jensen J, Burkhoff D, Frederiksen PH, Kistorp C, Videbaek L, Poulsen MK, Gustafsson F, Kober L, Borlaug BA, Schou M, Moller JE. Effect of Empagliflozin on Blood Volume Redistribution in Patients With Chronic Heart Failure and Reduced Ejection Fraction: An Analysis From the Empire HF Randomized Clinical Trial. Circ Heart Fail. 2022 Mar;15(3):e009156. doi: 10.1161/CIRCHEARTFAILURE.121.009156. Epub 2021 Nov 8.
- Derived from this study: PubMed 34509409Omar M, Jensen J, Frederiksen PH, Videbaek L, Poulsen MK, Brond JC, Gustafsson F, Borlaug BA, Schou M, Moller JE. Hemodynamic Determinants of Activity Measured by Accelerometer in Patients With Stable Heart Failure. JACC Heart Fail. 2021 Nov;9(11):824-835. doi: 10.1016/j.jchf.2021.05.013. Epub 2021 Sep 8.
- Derived from this study: PubMed 34061581Jensen J, Omar M, Kistorp C, Tuxen C, Gustafsson I, Kober L, Gustafsson F, Faber J, Forman JL, Moller JE, Schou M. Metabolic Effects of Empagliflozin in Heart Failure: A Randomized, Double-Blind, and Placebo-Controlled Trial (Empire HF Metabolic). Circulation. 2021 Jun;143(22):2208-2210. doi: 10.1161/CIRCULATIONAHA.120.053463. Epub 2021 Jun 1. No abstract available.
- Derived from this study: PubMed 33404637Omar M, Jensen J, Ali M, Frederiksen PH, Kistorp C, Videbaek L, Poulsen MK, Tuxen CD, Moller S, Gustafsson F, Kober L, Schou M, Moller JE. Associations of Empagliflozin With Left Ventricular Volumes, Mass, and Function in Patients With Heart Failure and Reduced Ejection Fraction: A Substudy of the Empire HF Randomized Clinical Trial. JAMA Cardiol. 2021 Jul 1;6(7):836-840. doi: 10.1001/jamacardio.2020.6827.
- Derived from this study: PubMed 33357505Jensen J, Omar M, Kistorp C, Tuxen C, Gustafsson I, Kober L, Gustafsson F, Faber J, Malik ME, Fosbol EL, Bruun NE, Forman JL, Jensen LT, Moller JE, Schou M. Effects of empagliflozin on estimated extracellular volume, estimated plasma volume, and measured glomerular filtration rate in patients with heart failure (Empire HF Renal): a prespecified substudy of a double-blind, randomised, placebo-controlled trial. Lancet Diabetes Endocrinol. 2021 Feb;9(2):106-116. doi: 10.1016/S2213-8587(20)30382-X. Epub 2020 Dec 22.
- Derived from this study: PubMed 31227014Jensen J, Omar M, Kistorp C, Poulsen MK, Tuxen C, Gustafsson I, Kober L, Gustafsson F, Fosbol E, Bruun NE, Videbaek L, Frederiksen PH, Moller JE, Schou M. Empagliflozin in heart failure patients with reduced ejection fraction: a randomized clinical trial (Empire HF). Trials. 2019 Jun 21;20(1):374. doi: 10.1186/s13063-019-3474-5.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Morten Schou, MD principal investigator
Herlev and Gentofte University Hospital
Jacob E Moller, MD principal investigator
Odense University Hospital
2 sites 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 10 MG in people with Heart Failure With Reduced Ejection Fraction, run by Morten Schou at 2 sites in Denmark.
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 9 inclusion and 16 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 5 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. 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?
Between-group difference in the change of plasma concentrations of NT-proBNP (time frame: 90 days). 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 NCT03198585, which also lists 11 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 5 Feb 2020.