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New treatment option for Heart Failure With Preserved Ejection Fraction
Official title Matching Perfusion and Metabolic Activity in HFpEF
ClinicalTrials.gov ID: NCT04913805
What this study is testing
What is Potassium Nitrate?
Potassium Nitrate is an investigational medicine, being studied as a potential treatment for heart failure with preserved ejection fraction.
Also referred to as KNO3.
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 increase perfusion [Potassium Nitrate (KNO3)], with and without additional supplements that may improve mitochondrial function [Propionyl-L-Carnitine (PLC) and Nicotinamide Riboside (NR)], 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
- NYHA Class II-III symptoms
- Left ventricular ejection fraction \>= 50%
- Stable medical condition for at least 2 weeks, as per investigator judgment
- Prior or current evidence for elevated filling pressures as follows: a. Mitral early (E)/mitral septal tissue annular (e') velocity ratio \> 8, in...
You likely can't join if
- Age \<18 years old
- Pregnancy:
- Treatment with organic nitrates or phosphodiesterase inhibitors that cannot be interrupted
- Uncontrolled atrial fibrillation, as defined by a resting heart rate \> 100 beats per minute at the time of the baseline assessment
- Hemoglobin \< 10 g/dL
- Subject inability/unwillingness to exercise
See the full eligibility criteria
- NYHA Class II-III symptoms
- Left ventricular ejection fraction \>= 50%
- Stable medical condition for at least 2 weeks, as per investigator judgment
- Prior or current evidence for elevated filling pressures as follows: a. Mitral early (E)/mitral septal tissue annular (e') velocity ratio \> 8, in the context of a septal e' velocity \ 34 mL/m2) ii. Chronic loop...
- Age \<18 years old
- Pregnancy:
- Treatment with organic nitrates or phosphodiesterase inhibitors that cannot be interrupted
- Uncontrolled atrial fibrillation, as defined by a resting 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 meeting Stage III or greater GOLD criteria (FEV1\<50%), treatment with oral steroids within the past 6 months for an exacerbation...
- 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/1.73m\^2
- Methemoglobin \> 5%
- Serum potassium \> 5.0 mEq/L
- Severe right ventricular dysfunction
- Baseline resting seated systolic blood pressure \> 180 mmHg or \< 100 mmHg
- Persistently low (\ 180 mmHg) seated blood pressure at the baseline visit
- Orthostatic blood pressure response to the transition from supine to standing (\>20 mmHg reduction in systolic blood pressure 2-3 minutes after standing)
- Active participation in another study that utilizes an investigational agent (observational studies/registries allowed)
- Any condition that, in the opinion of the investigator, will interfere with the performance and completion of the study.
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.