Status:
COMPLETED
Treatment of HFpEF With Nitrate Supplement
Lead Sponsor:
MaineHealth
Collaborating Sponsors:
HumanN
Conditions:
Heart Failure With Normal Ejection Fraction
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
Brief 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 imp...
Detailed Description
Heart failure (HF) is the most common principal diagnosis for hospital admission in patients over 65 years old. There are two types of HF, those with reduced ejection fraction (HFrEF) and those with p...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 29 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 22 2018
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT03289481
Start Date
June 29 2017
End Date
August 22 2018
Last Update
October 6 2021
Active Locations (1)
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1
Penobscot Bay Medical Center
Rockport, Maine, United States, 04856