53 Participants Needed

Empagliflozin + Potassium Nitrate for Heart Failure

(SAK Trial)

NT
AS
GG
CD
MF
Overseen ByMelissa Fernando
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 4 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

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).

Will I have to stop taking my current medications?

The trial requires that you stop taking organic nitrates or phosphodiesterase inhibitors if they cannot be interrupted. Other medications are not specifically mentioned, so it's best to discuss your current medications with the study team.

Is the combination of Empagliflozin and Potassium Nitrate safe for humans?

Empagliflozin (Jardiance) is generally safe for treating heart failure and diabetes, but it can cause side effects like fluid loss and, in rare cases, a serious condition called diabetic ketoacidosis (a dangerous buildup of acids in the blood). There is no specific safety data available for the combination with Potassium Nitrate.12345

How is the drug empagliflozin unique for treating heart failure?

Empagliflozin is unique for treating heart failure because it not only helps manage blood sugar levels in diabetes but also reduces the risk of hospitalization and death in heart failure patients, even those without diabetes. It works by promoting the removal of excess glucose and fluid from the body, which can help reduce symptoms like fluid retention and high blood pressure.12567

What data supports the effectiveness of the drug Empagliflozin for heart failure?

Empagliflozin has been shown to reduce the risk of hospitalization and death in people with heart failure, even if they don't have diabetes. It also improves quality of life for those with chronic heart failure.12589

Who Is on the Research Team?

PZ

Payman Zamani, MD

Principal Investigator

University of Pennsylvania

Are You a Good Fit for This Trial?

Adults with Heart Failure with Preserved Ejection Fraction (HFpEF) who have been on stable heart medication for at least a month. They should show signs of high heart pressure, have an ejection fraction >= 50%, and meet specific criteria related to the function of their heart valves. Pregnant women, individuals under 18, those with severe kidney or liver issues, uncontrolled diabetes or blood pressure problems, certain allergies, and people unable to exercise are excluded.

Inclusion Criteria

You have had high pressure in your heart during previous medical tests.
There is evidence that your heart is not pumping blood effectively.
I have heart issues indicated by specific heart function tests and symptoms.
See 5 more

Exclusion Criteria

I have heart issues found on a stress test that haven't been fixed or shown to be minor.
My heart beats more than 100 times a minute due to atrial fibrillation.
My kidney function is reduced, with an eGFR below 45.
See 29 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Empagliflozin with or without Potassium Nitrate for 6 weeks

6 weeks
Weekly visits (in-person)

Washout

A 2-week washout period following the treatment phase

2 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Empagliflozin
  • Potassium Nitrate
Trial Overview The trial is testing if Empagliflozin (a diabetes drug that might help the heart), alone or combined with Potassium Nitrate (which could improve blood flow and muscle energy use), can increase exercise ability in HFpEF patients compared to placebo. Participants will be randomly assigned to one of three groups: Empagliflozin + Potassium Chloride, Empagliflozin + Potassium Nitrate, or Placebo + Potassium Chloride.
How Is the Trial Designed?
3Treatment groups
Active Control
Placebo Group
Group I: Empagliflozin + Potassium Chloride (KCl)Active Control1 Intervention
Group II: Empagliflozin + Potassium Nitrate (KNO3)Active Control1 Intervention
Group III: Potassium Chloride (KCl) + Placebo for EmpaPlacebo Group1 Intervention

Empagliflozin is already approved in European Union, United States, Canada, Japan for the following indications:

๐Ÿ‡ช๐Ÿ‡บ
Approved in European Union as Jardiance for:
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Approved in United States as Jardiance for:
๐Ÿ‡จ๐Ÿ‡ฆ
Approved in Canada as Jardiance for:
๐Ÿ‡ฏ๐Ÿ‡ต
Approved in Japan as Jardiance for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials
2,118
Recruited
45,270,000+

Published Research Related to This Trial

In the EMPEROR-Reduced study involving over 3700 participants with chronic heart failure and reduced ejection fraction, empagliflozin significantly reduced the risk of hospitalization for heart failure complications (13.2% vs. 18.3% for placebo) over an average of 16 months.
Empagliflozin also showed a lower incidence of serious kidney problems (1.6% vs. 3.1% for placebo), indicating its potential safety and efficacy in managing heart failure, although it was associated with a higher rate of genital tract infections.
Drug treatment with empagliflozin lowered risk for hospitalization in people with heart failure with reduced ejection fraction: plain language summary of the EMPEROR-Reduced study.Zannad, F., Macari, S.[2023]
Empagliflozin (Jardiance) is now approved for reducing the risk of cardiovascular death and hospitalization in adults with heart failure, even in those without diabetes, highlighting its expanded therapeutic use.
Healthcare providers, including nurses and nurse practitioners, should closely monitor patients for potential adverse effects, particularly fluid deficits, to ensure patient safety during treatment.
Diabetes Drug Now Approved for Heart Failure.Aschenbrenner, DS.[2023]
Empagliflozin (EMPA) significantly reduced the induction of ventricular fibrillation (VF) in an ex-vivo model of ischemia-reperfusion, with only 16.7% of EMPA-treated hearts experiencing VF compared to 60% in control hearts.
EMPA improved cardiac contractility, as shown by a higher left ventricular developed pressure (LVDP) and enhanced calcium cycling, indicating its potential to protect heart function during ischemic events through mechanisms that do not involve sodium-glucose co-transporter-2 (SGLT2).
Anti-arrhythmic and inotropic effects of empagliflozin following myocardial ischemia.Azam, MA., Chakraborty, P., Si, D., et al.[2021]

Citations

Drug treatment with empagliflozin lowered risk for hospitalization in people with heart failure with reduced ejection fraction: plain language summary of the EMPEROR-Reduced study. [2023]
Diabetes Drug Now Approved for Heart Failure. [2023]
Anti-arrhythmic and inotropic effects of empagliflozin following myocardial ischemia. [2021]
Effects of empagliflozin on risk for cardiovascular death and heart failure hospitalization across the spectrum of heart failure risk in the EMPA-REG OUTCOMEยฎ trial. [2022]
Empagliflozin: A Review in Symptomatic Chronic Heart Failure. [2022]
Pharmacokinetics, Safety, and Bioequivalence of Two Empagliflozin Formulations after Single Oral Administration under Fasting and Fed Conditions in Healthy Chinese Subjects: An Open-label Randomized Single-dose Two-sequence, Two-treatment, Two-period Crossover Study. [2021]
Sodium-glucose Cotransporter-2 Induced Diabetic Ketoacidosis with Minimal Hyperglycemia. [2020]
[EMPAGLIFLOZIN (JARDIANCE) :Nw SGLT2 COTRANSPORTER INHIBITOR FOR TREATING TYPE 2 DIABETES]. [2022]
Drug treatment with empagliflozin was beneficial in people with heart failure with preserved ejection fraction: plain language summary of the EMPEROR-Preserved study. [2023]
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