Diabetes Mellitus, Type 2Phase 2NCT03554200
EMPA Acute Heart Failure
A Phase 2 study testing Empagliflozin in people with Diabetes Mellitus, Type 2 and Acute Heart Failure, run by RWTH Aachen University at 1 site in Germany.
Trial summary
In this study the investigators are aiming to treat patients with acute heart failure with or without diabetes with Empagliflozin or placebo. Given the beneficial effects of Empagliflozin on heart failure hospitalization in the EMPA-REG OUTCOME trial, the investigators do expect a similar beneficial effect to be… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2, Acute Heart Failure
- What is being tested?
- Empagliflozin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 19 participants
- Where
- 1 siteGermany
- Study dates
- 11 Jun 2018to 29 Oct 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Patients with acute heart failure with associated signs or symptoms (dyspnea on exertion, orthopnea, paroxysmal dyspnea, peripheral oedema, chest x-ray with pulmonary congestion)
- Serum levels of NT-proBNP ≥ 1000 pg/ml within 48 hours of Informed Consent
- Written informed consent prior to study participation
Who cannot join
- Type 1 diabetes
- Participants of child-bearing age without adequate contraception
- Pregnancy or lactating females
- Cardiogenic shock
- Acute coronary syndrome within 30 days prior to randomization
- Planned or recent percutaneous or surgical coronary intervention within 30 days prior to randomization
Show all 24Show fewer
- Signs of ketoacidosis and/or hyperosmolar hyperglycemic syndrome (pH ≤ 7.30 and glucose >14 mmol/l and HCO3- ≤ 18 mmol/l)
- Signs of uncontrolled active infection
- Dyspnea due to non-cardiac causes (severe pulmonary disease, anemia, severe obesity), non-HF causes such as acute or chronic respiratory disorders
- Coronary artery disease with requirement for revascularization within the study period
- Renal impairment (GFR < 20 ml/min/1,73 m2)
- Known hepatic impairment (as evidenced by total bilirubin >3 mg/dL) or history of cirrhosis with evidence of portal hypertension (e.g., presence of esophageal varices)
- Uncontrolled thyroid disease
- Endocrinopathies like Graves' disease, acromegaly, Cushings' disease
- Hypertensive retinopathy or encephalopathy
- Bariatric surgery in last 2 years prior to randomization
- Patients in whom study participation is not deemed appropriate under consideration of clinical wellbeing by the principal investigator
- The subject is mentally or legally incapacitated
- The subject received an investigational drug within 30 days prior to inclusion into this study
- Urinary tract infections or significant formation of residual urine in medical history
- Patients with particular risk for ketoacidosis (alcohol abuse, pancreatitis, pancreatic insulin deficiency from any cause, caloric restriction etc.) or ketoacidosis in the past
- Frequent hypoglycaemic events (in the opinion of the investigator)
- Intolerance to Empagliflozin and excipients in Empagliflozin or rather placebo
- Patients with severe stenosis or regurgitation of the aortic, pulmonary or mitral valve
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Internal Medicine I RWTH Aachen University Hospital
Aachen, North Rhine-Westphalia, 52074
About this study
Official title: Effect of Empagliflozin on Cardiac Output in Patients With Acute Heart Failure (EMPA Acute Heart Failure)
In this study the investigators are aiming to treat patients with acute heart failure with or without diabetes with Empagliflozin or placebo. Given the beneficial effects of Empagliflozin on heart failure hospitalization in the EMPA-REG OUTCOME trial, the investigators do expect a similar beneficial effect to be present in patients with acute heart failure. Acute heart failure is a state of hydropic decompensation resulting in dyspnea and congestions, caused by different etiologies of cardiac disease. Recompensation is reached by application of diuretic drugs and fluid restriction.
Read the detailed description
In the present study patients will be randomized into 2 groups (standard of care + Empagliflozin 10 mg/d or standard of care + placebo). Cardiac output will be assessed by a medical device for noninvasive monitoring of hemodynamic parameters (cardiac output, systemic vascular resistance, stroke volume and blood pressure) using finger cuff technology for pulse contour analysis.
These investigations will inform about Empagliflozin dependent effects on hemodynamic and cardiac function in patients with acute heart failure. The investigation will further assess the therapeutic efficacy of Empagliflozin on heart failure symptoms using objective (respiratory rate, oxygen requirement, peak expiratory flow rate, urinary volume, body weight, diuretic requirement, length of hospital stay) and well accepted, patient orientated secondary endpoints. In addition, metabolic regulators and parameters relevant for cardiac function and substrate metabolism will be assessed to further investigate possible mechanisms of Empagliflozin-dependent actions on cardiac function.
- Conditions
- Diabetes Mellitus, Type 2, Acute Heart Failure
- Being tested
- Empagliflozin, Placebo
- Keywords
- Empagliflozin, acute heart failure, cardiac output, left ventricular systolic and diastolic function, exercise capacity
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EmpagliflozinDrug
Also called Jardiance
Standard of Care + Empagliflozin: 10 mg (tablets) once daily
PlaceboDrug
Standard of Care + Placebo: Matching Placebo (tablets) once daily
| Study group | Role | What they receive |
|---|---|---|
| Empagliflozin | Experimental | Patients will receive empagliflozin 10 mg qd for a period of 30 days. Receives: Drug: Empagliflozin |
| Placebo | Placebo comparator | Patients of the placebo arm will receive placebo tablets qd for a period of 30 days. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
effect of Empagliflozin 10mg qd versus placebo on cardiac output in patients with acute heart failure
by ClearSight System
Measured: 30 days
Secondary outcomes (28)
Hemodynamics
Systemic vascular resistance (mmHg⋅min⋅mL-1)
Measured: 30 days
Hemodynamics
Stroke volume (ml/beat)
Measured: 30 days
Exercise Capacity
Hand grip
Measured: 30 days
Cardio vascular
blood pressure (mmHg)
Measured: 30 days
Effect of Empagliflozin on systemic quality of life
Quality of life questionnaire
Measured: 30 days
Effect of Empagliflozin on hospitalization due to cardiovascular causes or readmission for heart failure or renal failure
length of initial hospital stay
Measured: 30 days
Effect of Empagliflozin on death due to cardiovascular causes
days alive and out of hospital
Measured: 30 days
Urine
24 h sodium excretion (mmol/day)
Measured: 30 days
Body weight
body weight (kg)
Measured: 30 days
Cardio vascular
24 h heart rate (bpm)
Measured: 30 days
Blood
NT-proBNP (ng/l)
Measured: 30 days
Blood
cystatin C(mg/dl)
Measured: 30 days
Blood
serum levels of Glucose, Glucagon, Insulin, Total-Ketone bodies, Hydroxybutyrate, Aldosterone, Free fatty acidy (mg/dl)
Measured: 30 days
Blood
Hemoglobin, Haematocrit, Erythropoietin
Measured: 30 days
Respiratory rate
breaths/min
Measured: 30 days
Diuretic response
Δ weight kg/[(total i.v. dose)/40mg]+[(total oral dose)/80mg)] furosemide
Measured: 30 days
Kidney injury risk score
by NephroCheck® (defined by TIMP-2 x IGFBP7 in urine)
Measured: 30 days
change of microbiome
stool sample
Measured: 30 days
Patient-reported dyspnea
visual analogue scale (VAS), 7 point categorical Likert scale
Measured: 30 days
Peak expiratory flow rate
Measured: 30 days
Oxygen
Saturation (%)
Measured: 30 days
Oxygen
delivered (l/min)
Measured: 30 days
Clinical judged diuretic requirement
Measured: 30 days
Blood
eGFR
Measured: 30 days
Blood
Lactate, pH, HCO3-
Measured: 30 days
Blood
Serum osmolarity, Potassium, Chloride
Measured: 30 days
Effect of Empagliflozin 10 mg daily on Left ventricular systolic function
ejection fraction
Measured: 30 days
Effect of Empagliflozin 10 mg daily on Left ventricular diastolic function
2D and 3D parameter global strain rate E by echocardiography and by standardized parameter E/E' and left atrial (LA) volume
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2018
- Study start11 Jun 2018
- Primary completion29 Oct 2020
- Study completion29 Oct 2020
Why it stopped: COVID 19
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies 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
- Model description
- Single center, prospective, placebo-controlled, double blind, randomized, 2-arm parallel, interventional, exploratory pilot study
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- RWTH Aachen University
- Sponsor type
- University, hospital or other
- Collaborators
- Boehringer Ingelheim
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03554200
- Sponsor's protocol ID
- 15-156
- Other IDs
- 2017-002695-45, 2017
- Status last verified
- Oct 2022
- First submitted
- 17 May 2018
- Last updated
- 27 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Empagliflozin on Cardiac Output in Patients With Acute Heart Failure (EMPA Acute Heart Failure)
- ClinicalTrials.gov ID
- NCT03554200
- Acronym / sponsor ID
- 15-156
- Conditions
- Diabetes Mellitus, Type 2, Acute Heart Failure
- Keywords
- Empagliflozin, acute heart failure, cardiac output, left ventricular systolic and diastolic function, exercise capacity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: COVID 19
- Enrolment
- 19 participants (actual)
- Lead sponsor
- RWTH Aachen UniversityUniversity, hospital or other
- Collaborators
- Boehringer Ingelheim
- Study start
- 11 Jun 2018 (actual)
- Primary completion
- 29 Oct 2020 (actual)
- Study completion
- 29 Oct 2020 (actual)
- First posted
- 13 Jun 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.
In this study the investigators are aiming to treat patients with acute heart failure with or without diabetes with Empagliflozin or placebo. Given the beneficial effects of Empagliflozin on heart failure hospitalization in the EMPA-REG OUTCOME trial, the investigators do expect a similar beneficial effect to be present in patients with acute heart failure. Acute heart failure is a state of hydropic decompensation resulting in dyspnea and congestions, caused by different etiologies of cardiac disease. Recompensation is reached by application of diuretic drugs and fluid restriction.
Detailed description
In the present study patients will be randomized into 2 groups (standard of care + Empagliflozin 10 mg/d or standard of care + placebo). Cardiac output will be assessed by a medical device for noninvasive monitoring of hemodynamic parameters (cardiac output, systemic vascular resistance, stroke volume and blood pressure) using finger cuff technology for pulse contour analysis.
These investigations will inform about Empagliflozin dependent effects on hemodynamic and cardiac function in patients with acute heart failure. The investigation will further assess the therapeutic efficacy of Empagliflozin on heart failure symptoms using objective (respiratory rate, oxygen requirement, peak expiratory flow rate, urinary volume, body weight, diuretic requirement, length of hospital stay) and well accepted, patient orientated secondary endpoints. In addition, metabolic regulators and parameters relevant for cardiac function and substrate metabolism will be assessed to further investigate possible mechanisms of Empagliflozin-dependent actions on cardiac function.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Single center, prospective, placebo-controlled, double blind, randomized, 2-arm parallel, interventional, exploratory pilot study
| Arm | Type | Receives |
|---|---|---|
| Empagliflozin | Experimental | Drug: EmpagliflozinPatients will receive empagliflozin 10 mg qd for a period of 30 days. |
| Placebo | Placebo comparator | Drug: PlaceboPatients of the placebo arm will receive placebo tablets qd for a period of 30 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18 years
- Patients with acute heart failure with associated signs or symptoms (dyspnea on exertion, orthopnea, paroxysmal dyspnea, peripheral oedema, chest x-ray with pulmonary congestion)
- Serum levels of NT-proBNP ≥ 1000 pg/ml within 48 hours of Informed Consent
- Written informed consent prior to study participation
Key exclusion criteria (24 listed)
- Type 1 diabetes
- Participants of child-bearing age without adequate contraception
- Pregnancy or lactating females
- Cardiogenic shock
- Acute coronary syndrome within 30 days prior to randomization
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 |
|---|---|---|
| EmpagliflozinAlso: JardianceStandard of Care + Empagliflozin: 10 mg (tablets) once daily | Drug | Empagliflozin |
| PlaceboStandard of Care + Placebo: Matching Placebo (tablets) once daily | Drug | Placebo |
Primary outcome
effect of Empagliflozin 10mg qd versus placebo on cardiac output in patients with acute heart failure
Time frame: 30 days
by ClearSight System
28 secondary outcomes
Hemodynamics
Time frame: 30 days
Hemodynamics
Time frame: 30 days
Exercise Capacity
Time frame: 30 days
Cardio vascular
Time frame: 30 days
Effect of Empagliflozin on systemic quality of life
Time frame: 30 days
Effect of Empagliflozin on hospitalization due to cardiovascular causes or readmission for heart failure or renal failure
Time frame: 30 days
Effect of Empagliflozin on death due to cardiovascular causes
Time frame: 30 days
Urine
Time frame: 30 days
Body weight
Time frame: 30 days
Cardio vascular
Time frame: 30 days
Blood
Time frame: 30 days
Blood
Time frame: 30 days
Blood
Time frame: 30 days
Blood
Time frame: 30 days
Respiratory rate
Time frame: 30 days
Diuretic response
Time frame: 30 days
Kidney injury risk score
Time frame: 30 days
change of microbiome
Time frame: 30 days
Patient-reported dyspnea
Time frame: 30 days
Peak expiratory flow rate
Time frame: 30 days
Oxygen
Time frame: 30 days
Oxygen
Time frame: 30 days
Clinical judged diuretic requirement
Time frame: 30 days
Blood
Time frame: 30 days
Blood
Time frame: 30 days
Blood
Time frame: 30 days
Effect of Empagliflozin 10 mg daily on Left ventricular systolic function
Time frame: 30 days
Effect of Empagliflozin 10 mg daily on Left ventricular diastolic function
Time frame: 30 days
Results and safety
The study was stopped early (reason given: COVID 19). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2022.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 in people with Diabetes Mellitus, Type 2 and Acute Heart Failure, run by RWTH Aachen University 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 4 inclusion and 24 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: stopped early, as of the sponsor's last update on 27 Oct 2022. 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 was stopped early (reason given: COVID 19). Results are not available in the source record.
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?
effect of Empagliflozin 10mg qd versus placebo on cardiac output in patients with acute heart failure (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Oct 2022.