Treatment of HFpEF With Nitrate Supplement

• Status: Completed
• Trial end date: 2018-08-22
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: MaineHealth; Penobscot Bay Medical Center
• Collaborator: HumanN

Criteria

Inclusion Criteria:

1. 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

2. Stable medical therapy, defined as: no change in cardiac medications within 30 days

3. Willing to comply with the protocol and provide written informed consent

Exclusion Criteria:

1. Non-cardiac condition causing limitation of exercise tolerance

2. Acute coronary syndrome, myocardial infarction or cardiac revascularization within 60 days

3. Clinically significant valvular disease, defined as moderate-severe or severe stenosis or insufficiency

4. Significant ischemia seen on stress testing within the past 12 months that was not revascularized

5. Subject has taken and investigational medication within the past 30 days

6. History of allergy to beets

7. Systolic blood pressure of <100 at screening

8. Significant medical condition that would interfere with treatment, safety or compliance with the protocol