SGLT2i and KNO3 in HFpEF - The SAK HFpEF Trial
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests empagliflozin, with or without potassium nitrate, in people with heart failure whose heart still pumps out a normal share of blood (HFpEF). It will test whether these treatments help people exercise longer and help their muscles make energy.
This study will test whether pharmacologic agents that may improve mitochondrial function and energy fuel metabolism \[Empagliflozin (Empa)\], with and without additional supplements that increase perfusion and fatty acid oxidation \[Potassium Nitrate (KNO3)\], improve submaximal exercise endurance and skeletal muscle oxidative phosphorylation capacity (SkM OxPhos) in participants with Heart Failure with Preserved Ejection Fraction (HFpEF).
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Have heart failure symptoms that limit ordinary activity or activity that is easier than usual (NYHA class II–III).
- Have an ejection fraction of at least 50%. This is the share of blood the heart pumps out with each beat.
- Have a stable medical condition for at least 2 weeks, as judged by the study doctor.
- Have past or current signs of high pressure when the heart fills with blood. These must meet the study’s rules based on heart scans, pressure tests, or a past heart failure episode treated with water-removing medicine through a vein.
Who can't join
- Are under 18, are pregnant, cannot or do not want to exercise, or have a condition or travel problem that could prevent study completion.
- Take nitrate drugs or phosphodiesterase inhibitors that cannot be stopped; currently take or could not tolerate an SGLT2 inhibitor such as empagliflozin; or are in another study testing a drug.
- Have type 1 diabetes, a history of ketoacidosis (dangerous acid buildup in the blood), follow a ketogenic diet, or are allergic to beets.
- Have certain heart valve, heart muscle, or heart sac diseases; severe weakness of the heart’s right side; or uncontrolled atrial fibrillation, an irregular heartbeat with a resting rate over 100.
- Have certain heart blood-flow problems, recent acute heart disease or a heart artery procedure within 2 months, or a past ejection fraction below 45%, with a stated exception for a treated fast heart rhythm.
- Have certain serious lung diseases, high pressure in the lung arteries, recent oral steroid treatment for a lung flare-up, oxygen use other than nighttime oxygen for sleep apnea, or oxygen levels below 90% during the exercise test.
- Have serious liver disease, kidney filtering below 30, hemoglobin below 10 (low oxygen-carrying protein in blood), methemoglobin above 5% (a form that cannot carry oxygen well), or blood potassium above 5.0.
- Have a resting seated top blood pressure number above 180 or below 100, ongoing low or high seated blood pressure, or a blood pressure drop on standing that meets the study’s limits.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion: 1\. NYHA Class II-III symptoms 2. Left ventricular ejection fraction \>= 50% 3. Stable medical condition for at least 2 weeks, as per investigator judgment 4. Prior or current evidence for elevated filling pressures, as evidenced by at least one of the following: a. Mitral early (E)/septal tissue annular (e') velocity ratio \> 8, in the context of a septal e' velocity \<=7 cm/s or a lateral e' \<= 10 cm/s, in addition to one of the following: i. Large left atrium (LA volume index \> 34 mL/m2) ii. Chronic loop diuretic use for control of symptoms iii. Elevated natriuretic peptides within the past year (e.g., NTproBNP \> 125 pg/mL in sinus rhythm or \> 375 pg/mL if in atrial fibrillation) b. Mitral E/e' ratio \> 14 at rest or during exercise c. Elevated invasively-determined filling pressures previously (resting left ventricular end-diastolic pressure \>= 16 mm Hg or pulmonary capillary wedge pressure \>= 15 mmHg; or PCWP/LVEDP \>= 25 mmHg with exercise) d. Prior episode of acute heart failure requiring IV diuretics Exclusion Criteria: 1. Age \<18 years old 2. Pregnancy: Women of childbearing potential will undergo a urine pregnancy test during the screening visit. 3. Treatment with organic nitrates or phosphodiesterase inhibitors that cannot be interrupted 4. Uncontrolled atrial fibrillation, as defined by a resting atrial fibrillation heart rate \> 100 beats per minute at the time of the baseline assessment 5. Hemoglobin \< 10 g/dL 6. Subject inability/unwillingness to exercise 7. Moderate or greater left sided valvular disease (mitral regurgitation, aortic stenosis, aortic regurgitation), mild or greater mitral stenosis, severe right-sided valvular disease 8. Known hypertrophic, infiltrative, or inflammatory cardiomyopathy 9. Clinically significant pericardial disease, as per investigator judgment 10. Current angina due to clinically significant epicardial coronary disease, as per investigator judgment 11. Acute coronary syndrome or coronary intervention within the past 2 months 12. Primary pulmonary artery hypertension (WHO Group 1 Pulmonary Arterial Hypertension) 13. Clinically significant lung disease as defined by: Chronic Obstructive Pulmonary Disease Stage III or greater GOLD criteria (FEV1\<50%), treatment with oral steroids within the past 6 months for an exacerbation of obstructive lung disease, current use of supplemental oxygen aside from nocturnal oxygen for the treatment of obstructive sleep apnea. \- Desaturation to \<90% on the baseline maximal effort cardiopulmonary exercise test will also be grounds for exclusion 14. Clinically-significant ischemia, as per investigator's judgement, on stress testing without either (1) subsequent revascularization, (2) an angiogram demonstrating the absence of clinically significant epicardial coronary artery disease, as per investigator judgment; (3) a follow-up 'negative' stress test, particularly when using a more specific technique (i.e., a negative perfusion imaging test following a 'positive' ECG stress test) \- Exercise-induced regional wall motion abnormalities on the echocardiographic assessment during the baseline maximal effort cardiopulmonary exercise test will also be exclusionary 15. Left ventricular ejection fraction \< 45% on a prior echocardiogram or cardiac MRI, unless the reduced LVEF occurred within the context of an uncontrolled supraventricular arrhythmia, with return of a normal ejection fraction following treatment of the arrhythmia 16. Significant liver disease impacting synthetic function or volume control (ALT/AST \> 3x ULN, Albumin \< 3.0 g/dL) 17. eGFR \< 30 mL/min/1.73m2. 18. Methemoglobin \> 5% 19. Serum potassium \> 5.0 mEq/L on baseline testing 20. Type I Diabetes 21. History of ketoacidosis 22. Current use of, or prior intolerance to, an SGLT2i 23. Ongoing maintenance of a 'Ketogenic Diet' (low carbohydrate, high fat) 24. Allergy to beets 25. Severe right ventricular dysfunction 26. Baseline resting seated systolic blood pressure \> 180 mmHg or \< 100 mmHg 27. Persistently low or high seated blood pressure or orthostatic blood pressure response to the transition from supine to standing (\>20 mmHg reduction in systolic blood pressure 2-3 minutes after standing, or a fall in SBP to \< 90 mmHg) at the baseline visit 28. Active participation in another study that utilizes an investigational agent (observational studies/registries allowed) 29. Any condition that, in the opinion of the investigator, may interfere with the completion/performance of the study. This may include comorbid or psychiatric conditions that may impede successful completion of the protocol, or logistical concerns (e.g., inability to travel to the exercise unit).
Study sites (1)
PA
- University of Pennsylvania Health System · Philadelphia, PA 19104Cassandra J Demastus · Study contact · Cassandra.Demastus@Pennmedicine.upenn.eduMore trials in Philadelphia