Early Phase 1
N=13
Treatment of HFpEF With Nitrate Supplement
Heart Failure With Normal Ejection Fraction
Bottom Line
View on ClinicalTrials.gov: NCT03289481 ↗Enrolled (actual)
13
Serious AEs
0.0%
Results posted
Aug 2019
Primary outcome: Primary: Time on Treadmill — 402.8; 181.2 seconds
Study Design & Population
- Study type
- Interventional
- Phase
- Early Phase 1
- Interventions
- Active lozenge (Dietary_supplement); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- MaineHealth
- Primary completion
- Aug 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time on Treadmill |
402.8; 181.2 | — |
| PRIMARY Metabolic Equivalents |
7.99; 8.46 | — |
| PRIMARY E/E Prime |
1.93; -.05 | — |
| PRIMARY Estimated Right Ventricular Systolic Pressure |
11.79; 8.6 | — |
Summary
The objective of this project is to determine if Neo40, a nitric oxide generating lozenge, when consumed twice daily by subjects with HFpEF, will increase exercise tolerance, decrease symptoms and improve quality of life for patients.
Eligibility Criteria
Inclusion Criteria
- Diagnosis of HFpEF, defined as:
- symptomatic with one of more of the following: orthopnea, paroxysmal nocturnal dyspnea, lower-extremity edema, dyspnea on exertion; AND
- ejection fraction >50%
- ratio of early mitral inflow velocity to septal tissue dopler velocity >8; AND
- one or more of the following: left atrium measurement >34 mL/m2, elevated N-terminal pro-brain natriuretic peptide level within the past 12 months, long term loop diuretic use for control of symptoms or elevated filling pressures on prior cardiac catheterization
- Stable medical therapy, defined as: no change in cardiac medications within 30 days
- Willing to comply with the protocol and provide written informed consent
Exclusion Criteria
- Non-cardiac condition causing limitation of exercise tolerance
- Acute coronary syndrome, myocardial infarction or cardiac revascularization within 60 days
- Clinically significant valvular disease, defined as moderate-severe or severe stenosis or insufficiency
- Significant ischemia seen on stress testing within the past 12 months that was not revascularized
- Subject has taken and investigational medication within the past 30 days
- History of allergy to beets
- Systolic blood pressure of <100 at screening
- Significant medical condition that would interfere with treatment, safety or compliance with the protocol
Data sourced from ClinicalTrials.gov (NCT03289481). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.