Is NCT05138575 recruiting in Philadelphia, PA?

Yes, NCT05138575 is currently recruiting participants at its Philadelphia, PA location. This heart failure with preserved ejection fraction clinical trial is actively enrolling qualified participants.

Is participation in this Philadelphia clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Heart Failure With Preserved Ejection Fraction Clinical Trial in Philadelphia, PA

Q: How do I join the heart failure with preserved ejection fraction clinical trial in Philadelphia?

To join this clinical trial in Philadelphia, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

About This Heart Failure With Preserved Ejection Fraction Study in Philadelphia

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).

Sponsor: University of Pennsylvania

Who Can Participate

Inclusion Criteria

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

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 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

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

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

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 SBP to \< 90 mmHg) at the baseline visit

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 protocol, or logistical concerns (e.g., inability to travel to the exercise unit).

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Philadelphia?

Yes, this clinical trial (NCT05138575) has an active research site in Philadelphia, PA that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Heart Failure With Preserved Ejection Fraction Treatment Options in Philadelphia, PA

If you're searching for heart failure with preserved ejection fraction treatment options in Philadelphia, PA, this clinical trial (NCT05138575) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Philadelphia research site is actively enrolling participants for this clinical trial. You'll receive care from experienced heart failure with preserved ejection fraction specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all heart failure with preserved ejection fraction clinical trials near you to find additional studies recruiting in your area.

Heart Failure With Preserved Ejection Fraction Clinical Trial in Philadelphia, PA

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