Heart Failure with Preserved Ejection FractionPhase 4NCT05139472
Impact of Empagliflozin on Functional Capacity in Heart Failure with Preserved Ejection Fraction
A Phase 4 study testing Empagliflozin 10 MG in people with Heart Failure with Preserved Ejection Fraction and Heart Failure, Diastolic, run by University of Texas Southwestern Medical Center at 2 sites in United States.
Trial summary
Sodium-Glucose Cotransporter-2 (SGLT-2) inhibitors generally and empagliflozin specifically have shown cardiovascular benefits in patients with heart failure (HF), but the underlying mechanisms remain unclear. Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Heart Failure with Preserved Ejection Fraction, Heart Failure, Diastolic, Diabetes Mellitus
- What is being tested?
- Empagliflozin 10 MG
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 2 sitesUnited States
- Study dates
- 9 Nov 2021to 19 Feb 2024
- 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 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adults ages 50-85
- clinical heart failure
- ejection fraction > 50%
Who cannot join
- previous hypersensitivity or adverse reaction to SGLT-2 inhibitors
- currently treated with SGLT-2 inhibitor
- current or prior ejection fraction <50%
- chronic kidney disease with glomerular filtration rate < 45 ml/kg/min
- unstable coronary artery disease
- significant arrhythmia
- BMI >55 kg/m2
- inability to exercise.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Institute for Exercise and Environmental Medicine
Dallas, Texas, 75231
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
About this study
Sodium-Glucose Cotransporter-2 (SGLT-2) inhibitors generally and empagliflozin specifically have shown cardiovascular benefits in patients with heart failure (HF), but the underlying mechanisms remain unclear. Empagliflozin use resulted in lower pulmonary artery diastolic pressures in patients with HF, suggesting a beneficial diuretic effect. Other potential mechanisms include increased blood volume, decreased blood pressure, and changes in sympathetic and neuro-hormonal activation.
This study is a single-arm, open label, prospective interventional study of 8 subjects with heart failure with preserved ejection fraction (HFpEF). Before and after 12 weeks of daily empagliflozin, participants with undergo comprehensive invasive exercise testing with a right heart catheter. Our goal is to evaluate the effects of empagliflozin on fitness, assessed by peak VO2, and peak left ventricular filling pressure, assessed by pulmonary capillary pressure at peak exercise.
Read the detailed description
This is a single-arm, open label, pilot study of 8 subjects with HFpEF. The subjects will undergo screening tests (exercise stress echo and blood work) to evaluate for potential exclusion criteria and provide familiarization to the exercise protocol. Those included will undergo an echocardiogram and invasive cardiopulmonary exercise test. This involves placement of a right heart catheter in the pulmonary artery and undergoing seated, upright exercise. During the exercise test, the subject's oxygen uptake (VO2), intra-cardiac pressures (right atrial pressure, pulmonary capillary wedge pressure) and cardiac output (Qc) will be measured. The subject will take a dose of empagliflozin in the lab and wait for at least 60 minutes. They will repeat a shortened version of the exercise test in the afternoon. After baseline testing, each subject will take 10mg empagliflozin daily for 12 weeks. They will have repeat blood work (specific electrolytes and renal function) 30 days after starting medication to screen for renal injury. After 12 weeks, they will return for another invasive cardiopulmonary exercise test and echocardiogram.
- Conditions
- Heart Failure with Preserved Ejection Fraction, Heart Failure, Diastolic, Diabetes Mellitus
- Being tested
- Empagliflozin 10 MG
- Keywords
- Exercise, Invasive Exercise Testing, SGLT-2 Inhibitors
- Medical subject headings
- Heart Failure, Diastolic, Diabetes Mellitus, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Empagliflozin 10 MGDrug
Daily Empagliflozin
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm | Experimental | This arm of the study will take 10 mg empagliflozin daily for 12 weeks Receives: Drug: Empagliflozin 10 MG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak Oxygen Uptake
Peak VO2 measured on maximal exercise test
Measured: 12 weeks
Peak Pulmonary Capillary Wedge Pressure (PCWP)
Peak PCWP, measured at end-expiration, at the end of maximal exercise test
Measured: 12 weeks
Secondary outcomes (9)
Primary Endpoints after single dose of empagliflozin
Peak VO2 and peak PCWP will be measured after a single dose of empagliflozin
Measured: 1 hour
Cardiac Output at Rest and During Exercise
Measured: 12 weeks
Stroke Volume at Rest and During Exercise
Measured: 12 weeks
Right Atrial Pressure at Rest and During Exercise
Measured: 12 weeks
Pulmonary Capillary Wedge Pressure at Rest and During Submaximal Exercise
Measured: 12 weeks
Left ventricular volumes at rest and during submaximal exercise
Measured by echocardiography
Measured: 12 weeks
Hemoglobin mass, plasma volume, total blood volume
Measured by Carbon Monoxide Rebreathe
Measured: 12 weeks
Diastolic parameters at rest and during submaximal exercise
Measured by echocardiography
Measured: 12 weeks
6 minute walk time
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2021
- Study start9 Nov 2021
- Primary completion20 Sep 2023
- Study completion19 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure with Preserved Ejection FractionStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single arm, open label trial
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Boehringer Ingelheim
- Responsible party
- Principal investigator, James MacNamara, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05139472
- Sponsor's protocol ID
- STU 2018-0311
- Status last verified
- Sep 2024
- First submitted
- 10 Nov 2021
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: De-identified data may be made available upon reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Empagliflozin on Functional Capacity in Heart Failure with Preserved Ejection Fraction
- ClinicalTrials.gov ID
- NCT05139472
- Acronym / sponsor ID
- STU 2018-0311
- Conditions
- Heart Failure with Preserved Ejection Fraction, Heart Failure, Diastolic, Diabetes Mellitus
- Keywords
- Exercise, Invasive Exercise Testing, SGLT-2 Inhibitors
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Collaborators
- Boehringer Ingelheim
- Study start
- 9 Nov 2021 (actual)
- Primary completion
- 20 Sep 2023 (actual)
- Study completion
- 19 Feb 2024 (actual)
- First posted
- 1 Dec 2021 (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.
Sodium-Glucose Cotransporter-2 (SGLT-2) inhibitors generally and empagliflozin specifically have shown cardiovascular benefits in patients with heart failure (HF), but the underlying mechanisms remain unclear. Empagliflozin use resulted in lower pulmonary artery diastolic pressures in patients with HF, suggesting a beneficial diuretic effect. Other potential mechanisms include increased blood volume, decreased blood pressure, and changes in sympathetic and neuro-hormonal activation.
This study is a single-arm, open label, prospective interventional study of 8 subjects with heart failure with preserved ejection fraction (HFpEF). Before and after 12 weeks of daily empagliflozin, participants with undergo comprehensive invasive exercise testing with a right heart catheter. Our goal is to evaluate the effects of empagliflozin on fitness, assessed by peak VO2, and peak left ventricular filling pressure, assessed by pulmonary capillary pressure at peak exercise.
Detailed description
This is a single-arm, open label, pilot study of 8 subjects with HFpEF. The subjects will undergo screening tests (exercise stress echo and blood work) to evaluate for potential exclusion criteria and provide familiarization to the exercise protocol. Those included will undergo an echocardiogram and invasive cardiopulmonary exercise test. This involves placement of a right heart catheter in the pulmonary artery and undergoing seated, upright exercise. During the exercise test, the subject's oxygen uptake (VO2), intra-cardiac pressures (right atrial pressure, pulmonary capillary wedge pressure) and cardiac output (Qc) will be measured. The subject will take a dose of empagliflozin in the lab and wait for at least 60 minutes. They will repeat a shortened version of the exercise test in the afternoon. After baseline testing, each subject will take 10mg empagliflozin daily for 12 weeks. They will have repeat blood work (specific electrolytes and renal function) 30 days after starting medication to screen for renal injury. After 12 weeks, they will return for another invasive cardiopulmonary exercise test and echocardiogram.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single arm, open label trial
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm | Experimental | Drug: Empagliflozin 10 MGThis arm of the study will take 10 mg empagliflozin daily for 12 weeks |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- adults ages 50-85
- clinical heart failure
- ejection fraction > 50%
Key exclusion criteria (8 listed)
- previous hypersensitivity or adverse reaction to SGLT-2 inhibitors
- currently treated with SGLT-2 inhibitor
- current or prior ejection fraction <50%
- chronic kidney disease with glomerular filtration rate < 45 ml/kg/min
- unstable coronary artery disease
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 MGDaily Empagliflozin | Drug | Treatment Arm |
Primary outcome
Peak Oxygen Uptake
Time frame: 12 weeks
Peak VO2 measured on maximal exercise test
Peak Pulmonary Capillary Wedge Pressure (PCWP)
Time frame: 12 weeks
Peak PCWP, measured at end-expiration, at the end of maximal exercise test
9 secondary outcomes
Primary Endpoints after single dose of empagliflozin
Time frame: 1 hour
Cardiac Output at Rest and During Exercise
Time frame: 12 weeks
Stroke Volume at Rest and During Exercise
Time frame: 12 weeks
Right Atrial Pressure at Rest and During Exercise
Time frame: 12 weeks
Pulmonary Capillary Wedge Pressure at Rest and During Submaximal Exercise
Time frame: 12 weeks
Left ventricular volumes at rest and during submaximal exercise
Time frame: 12 weeks
Hemoglobin mass, plasma volume, total blood volume
Time frame: 12 weeks
Diastolic parameters at rest and during submaximal exercise
Time frame: 12 weeks
6 minute walk time
Time frame: 12 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 19 Sep 2024.
- Individual participant dataSharing planned: No. De-identified data may be made available upon reasonable request
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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.
2 sites 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 with Preserved Ejection Fraction and Heart Failure, Diastolic, run by University of Texas Southwestern Medical Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 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 19 Sep 2024. 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 United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Peak Oxygen Uptake (time frame: 12 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?
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 19 Sep 2024.