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Treatment of HFpEF With Nitrate Supplement

NCT03289481 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2021-10-06

Study results available
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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

Interventions

DIETARY_SUPPLEMENT

Active lozenge

nitric oxide generating lozenge

DRUG

Placebo

placebo tablet

Sponsors & Collaborators

  • HumanN

    collaborator INDUSTRY

  • MaineHealth

    lead OTHER

Principal Investigators

  • Ralph Hamill, MD · MaineHealth

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-06-29
Primary Completion
2018-08-22
Completion
2018-08-22
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03289481 on ClinicalTrials.gov