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SGLT2 Inhibitor
Empagliflozin + Potassium Nitrate for Heart Failure
Phase 2
Recruiting
Led By Payman Zamani, MD
Research Sponsored by University of Pennsylvania
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
NYHA Class II-III symptoms
Prior episode of acute heart failure requiring IV diuretics
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 6
Awards & highlights
Study Summary
This trial will test if two drugs can improve exercise endurance and muscle function in people with heart failure.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Possible side effects include low blood sugar levels especially in diabetics taking other medications for it; dehydration leading to low blood pressure; urinary tract infections due to increased urination; allergic reactions; elevated potassium levels which can affect your heartbeat; and potential negative interactions with diuretics.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have moderate heart condition symptoms.
Select...
I have been treated with IV diuretics for acute heart failure before.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 6
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 6
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Submaximal Exercise Endurance
Secondary outcome measures
Ambulatory Physical Activity
Arteriovenous O2 content difference
Intramuscular Perfusion
+10 moreOther outcome measures
Intramyocardial Filling Pressure
Trial Design
3Treatment groups
Active Control
Placebo Group
Group I: Empagliflozin + Potassium Chloride (KCl)Active Control1 Intervention
Empagliflozin (10 mg daily) + Potassium Chloride (6 mmol three times daily)
Active arm will be 6 weeks in duration followed by a 2 week washout period.
Group II: Empagliflozin + Potassium Nitrate (KNO3)Active Control1 Intervention
Empagliflozin (10 mg daily) + Potassium Nitrate (6 mmol three times daily)
Active arm will be 6 weeks in duration followed by a 2 week washout period.
Group III: Potassium Chloride (KCl) + Placebo for EmpaPlacebo Group1 Intervention
Potassium Chloride (6 mmol three times daily) + Placebo for Empagliflozin
Placebo arm will be 6 weeks in duration followed by a 2 week washout period.
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Who is running the clinical trial?
University of PennsylvaniaLead Sponsor
2,002 Previous Clinical Trials
42,880,816 Total Patients Enrolled
42 Trials studying Heart Failure
7,461 Patients Enrolled for Heart Failure
Payman Zamani, MDPrincipal InvestigatorUniversity of Pennsylvania
1 Previous Clinical Trials
84 Total Patients Enrolled
1 Trials studying Heart Failure
84 Patients Enrolled for Heart Failure
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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 found on a stress test that haven't been fixed or shown to be minor.I have heart issues indicated by specific heart function tests and symptoms.My heart beats more than 100 times a minute due to atrial fibrillation.My kidney function is reduced, with an eGFR below 45.I have severe lung disease and may be using oxygen or steroids.I will take a pregnancy test if I can still have children.I am taking medication for heart or erection problems that cannot be stopped.I have had ketoacidosis in the past.Your blood pressure drops by a lot when you stand up.I have had a heart attack or heart procedure in the last 2 months.My heart's right side is not pumping well.You have a serious heart condition related to the sac around the heart, as determined by the doctor.I have a diagnosed heart muscle condition.I have chest pain due to a heart condition, as diagnosed by my doctor.My medication for blood pressure or heart rate has been stable for the last month.I have significant heart valve issues.Your blood pressure is very high (over 180 mmHg) or very low (under 100 mmHg) when you are sitting and resting.I have moderate heart condition symptoms.I have been treated with IV diuretics for acute heart failure before.Your heart's pumping ability is at least 50%.You cannot have an MRI for medical reasons.My liver is not working well (high enzyme levels or low albumin).I have high blood pressure in the lungs' arteries.You have a high level of methemoglobin in your blood.Your heart's pumping function was found to be below 45% on a previous heart test.I have Type I Diabetes.You are allergic to beets.You are currently following a specific diet called the "Ketogenic Diet" with low carbohydrates and high fat.If your oxygen level drops below 90% during an exercise test, you will not be able to participate in the study.Your blood test shows that your potassium level is higher than 5.0 mEq/L before starting the study.I am currently using or have had a bad reaction to an SGLT2 inhibitor.I am under 18 years old.Your hemoglobin level is less than 10 grams per deciliter.If your heart shows abnormal movement during an exercise test, you may not be able to join the study.You are not able or willing to do physical activity.Your heart's E/e' ratio is greater than 14 when you are resting or exercising.
Research Study Groups:
This trial has the following groups:- Group 1: Potassium Chloride (KCl) + Placebo for Empa
- Group 2: Empagliflozin + Potassium Chloride (KCl)
- Group 3: Empagliflozin + Potassium Nitrate (KNO3)
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Who meets the criteria to participate in this trial?
"Eligibility criteria for this clinical trial requires that participants are between 18 and 90 years old, have heart failure, and amount to 53 people in total."
Answered by AI
Is the combined ingestion of Empagliflozin and Potassium Nitrate hazardous to patients?
"Our team at Power gave Empagliflozin + Potassium Nitrate (KNO3) a score of 2, as the current clinical data confirms safety but does not yet demonstrate efficacy."
Answered by AI
What is the cap on participants in this research endeavor?
"Affirmative. According to information available from clinicaltrials.gov, this medical trial is presently recruiting participants with the first posting on January 24th 2022 and the most recent update being May 25th 2022. 53 patients are needed for a single site."
Answered by AI
Are volunteers now being accepted for this research endeavor?
"Affirmative, the data on clinicaltrials.gov reveals that this medical study is presently seeking patients. It was inaugurated on January 24th 2022 and its content most recently revised on May 25th 2022. The trial requires 53 volunteers at a solitary site for completion."
Answered by AI
What medicinal purpose does the combination of Empagliflozin and Potassium Nitrate (KNO3) generally serve?
"Empagliflozin + Potassium Nitrate (KNO3) is commonly used in terminal situations and has demonstrated efficacy in treating hypokalemia, heart failure, and minimising the effects of urine alkalinization therapy."
Answered by AI
What precedent has been established for the combination of Empagliflozin and Potassium Nitrate (KNO3) in clinical trials?
"Presently, there are 73 active research initiatives exploring the potential of Empagliflozin + Potassium Nitrate (KNO3), with 15 trials in their latter stages. Although a great deal of these experiments take place within Quilmes, Maryland, data from clinicaltrials.gov reveals that 1057 sites across the world are participating in this investigation."
Answered by AI
Does this investigation include participants aged 25 or over?
"According to the criteria outlined by this clinical trial, only those aged 18-90 are eligible. Additionally, 27 studies target below 18 year olds and 754 research projects focus on persons above 65 years of age."
Answered by AI
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