Heart Failure With Normal Ejection Fraction Clinical Trial
Official title:
Treatment of HFpEF With Nitrate Supplement: A Double-blind, Placebo Controlled Trial Including Patients With Atrial Fibrillation
Verified date | September 2021 |
Source | MaineHealth |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 13 |
Est. completion date | August 22, 2018 |
Est. primary completion date | August 22, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Penobscot Bay Medical Center | Rockport | Maine |
Lead Sponsor | Collaborator |
---|---|
MaineHealth | HumanN |
United States,
Borlaug BA, Koepp KE, Melenovsky V. Sodium Nitrite Improves Exercise Hemodynamics and Ventricular Performance in Heart Failure With Preserved Ejection Fraction. J Am Coll Cardiol. 2015 Oct 13;66(15):1672-82. doi: 10.1016/j.jacc.2015.07.067. — View Citation
Eggebeen J, Kim-Shapiro DB, Haykowsky M, Morgan TM, Basu S, Brubaker P, Rejeski J, Kitzman DW. One Week of Daily Dosing With Beetroot Juice Improves Submaximal Endurance and Blood Pressure in Older Patients With Heart Failure and Preserved Ejection Fraction. JACC Heart Fail. 2016 Jun;4(6):428-37. doi: 10.1016/j.jchf.2015.12.013. Epub 2016 Feb 10. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Time on Treadmill | change in total time traveled on treadmill | after one week of active lozenges compared to one week of placebo lozenges | |
Primary | Metabolic Equivalents | change in metabolic equivalents on treadmill | after one week of active lozenges compared to one week of placebo lozenges | |
Primary | E/E Prime | change in E/E prime on exercise echo (E/E prime is a ratio between early mitral inflow velocity and mitral annular early diastolic velocity in order to measure diastolic dysfunction) | after one week of active lozenges compared to one week of placebo lozenges | |
Primary | Estimated Right Ventricular Systolic Pressure | change in estimated right ventricular systolic pressure on echo | after one week of active lozenges compared to one week of placebo lozenges |
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