Treatment of HFpEF With Nitrate Supplement

NCT03289481 | Completed Early Phase 1 Results FDA Drug

• 1 other identifier: Neo40 Study
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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 improve quality of life for patients.

Conditions

Heart Failure With Normal Ejection Fraction

Keywords

Heart failure; HFpEF; Nitrate supplement

Outcome Measures

Primary Outcomes (4)

• Time on Treadmill

  change in total time traveled on treadmill

  after one week of active lozenges compared to one week of placebo lozenges

• Metabolic Equivalents

  change in metabolic equivalents on treadmill

  after one week of active lozenges compared to one week of placebo lozenges

• 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

• 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

Study Arms (2)

Active lozenge first

ACTIVE COMPARATOR

Subject will take active lozenge (Vitamin C, Vitamin B12, Nitric Oxide Blend, L-citrulline, Sodium Nitrite) for one week, perform cardiac testing then take placebo lozenge for one week and perform cardiac testing.

Dietary Supplement: Active lozenge; Drug: Placebo

Placebo lozenge first

ACTIVE COMPARATOR

Subject will take placebo lozenge for one week, perform cardiac testing then take active lozenge (Vitamin C, Vitamin B12, Nitric Oxide Blend, L-citrulline, Sodium Nitrite) for one week and perform cardiac testing.

Dietary Supplement: Active lozenge; Drug: Placebo

Interventions

Active lozenge DIETARY_SUPPLEMENT

nitric oxide generating lozenge

Active lozenge first; Placebo lozenge first

Placebo DRUG

placebo tablet

Active lozenge first; Placebo lozenge first

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• MaineHealth: lead
• HumanN: collaborator

Study Sites (1)

Penobscot Bay Medical Center

Rockport, Maine, 04856, United States

Location

Related Publications (2)

• 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.

  PMID: 26874390 BACKGROUND

• 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.

  PMID: 26449137 BACKGROUND

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Limitations and Caveats

Low enrollment number

Results Point of Contact

• Title: Caroline Knight
• Organization: Clinical Research

CKnight@pbmc.org

2079218959

Study Officials

• Ralph Hamill, MD

  MaineHealth

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Masking will be done by the pharmacy. Active and placebo lozenges will look identical.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Cardiologist

Model Details: Double-blind, placebo controlled crossover study

Study Record Dates

• First Submitted: September 18, 2017
• First Posted: September 21, 2017
• Study Start: June 29, 2017
• Primary Completion: August 22, 2018
• Study Completion: August 22, 2018
• Last Updated: October 6, 2021
• Results First Posted: August 26, 2019

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)