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New treatment option for Heart Failure With Preserved Ejection Fraction
Official title SGLT2i and KNO3 in HFpEF - The SAK HFpEF Trial
ClinicalTrials.gov ID: NCT05138575
What this study is testing
What is Empagliflozin + Potassium Chloride?
Empagliflozin + Potassium Chloride is an investigational medicine, given as an injection into a muscle, being studied as a potential treatment for heart failure with preserved ejection fraction.
Also referred to as Jardiance + KCl.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- a. Mitral early (E)/septal tissue annular (e') velocity ratio \> 8, in the context of a septal e' velocity \ 34 mL/m2) ii. Chronic loop diuretic use...
You likely can't join if
- Age \<18 years old
- Pregnancy: Women of childbearing potential will undergo a urine pregnancy test during the screening visit.
- Treatment with organic nitrates or phosphodiesterase inhibitors that cannot be interrupted
- Uncontrolled atrial fibrillation, as defined by a resting atrial fibrillation heart rate \> 100 beats per minute at the time of the baseline...
- Hemoglobin \< 10 g/dL
- Subject inability/unwillingness to exercise
See the full 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...
- a. Mitral early (E)/septal tissue annular (e') velocity ratio \> 8, in the context of a septal e' velocity \ 34 mL/m2) ii. Chronic loop diuretic use for control of symptoms iii. Elevated natriuretic peptides within the...
- Age \<18 years old
- Pregnancy: Women of childbearing potential will undergo a urine pregnancy test during the screening visit.
- Treatment with organic nitrates or phosphodiesterase inhibitors that cannot be interrupted
- Uncontrolled atrial fibrillation, as defined by a resting atrial fibrillation heart rate \> 100 beats per minute at the time of the baseline assessment
- Hemoglobin \< 10 g/dL
- Subject inability/unwillingness to exercise
- Moderate or greater left sided valvular disease (mitral regurgitation, aortic stenosis, aortic regurgitation), mild or greater mitral stenosis, severe right-sided valvular disease
- Known hypertrophic, infiltrative, or inflammatory cardiomyopathy
- Clinically significant pericardial disease, as per investigator judgment
- Current angina due to clinically significant epicardial coronary disease, as per investigator judgment
- Acute coronary syndrome or coronary intervention within the past 2 months
- Primary pulmonary artery hypertension (WHO Group 1 Pulmonary Arterial Hypertension)
- 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...
- 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...
- 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...
- Significant liver disease impacting synthetic function or volume control (ALT/AST \> 3x ULN, Albumin \< 3.0 g/dL)
- eGFR \< 30 mL/min/1.73m2.
- Methemoglobin \> 5%
- Serum potassium \> 5.0 mEq/L on baseline testing
- Type I Diabetes
- History of ketoacidosis
- Current use of, or prior intolerance to, an SGLT2i
- Ongoing maintenance of a 'Ketogenic Diet' (low carbohydrate, high fat)
- Allergy to beets
- Severe right ventricular dysfunction
- Baseline resting seated systolic blood pressure \> 180 mmHg or \< 100 mmHg
- 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...
- Active participation in another study that utilizes an investigational agent (observational studies/registries allowed)
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Philadelphia, Pennsylvania, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Philadelphia, Pennsylvania, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.