The Inorganic Nitrate and eXercise Performance in Heart Failure (iNIX-HF)

NCT05562167 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2026-05-06

No results posted yet for this study

Summary

The goals of this project are to determine the effectiveness of acute (2 hours after a single dose) and chronic (after 6 weeks of once-a-day dosing) KNO3 treatment (10mmol) vs. placebo on quadriceps muscle power and on aerobic exercise performance (V̇O2peak) in patients with HFrEF (left ventricular ejection fraction \<45%). The investigators hypothesize that both acute and chronic dosing of 10mmol of KNO3 will improve exercise performance in HFrEF. To test this hypothesis, the investors will perform a randomized, double-blind, placebo-controlled, parallel-arm design study.

Conditions

Interventions

DRUG

KNO3

10 mmol of KNO3 via a single gel capsule to be consumed orally once per day for 6 weeks.

DRUG

Placebo

10 mmol of placebo via a single gel capsule to be consumed orally once per day for 6 weeks.

Sponsors & Collaborators

  • Washington University School of Medicine

    lead OTHER

Principal Investigators

  • Linda R Peterson, MD · Washington University School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
79 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-31
Primary Completion
2027-05-31
Completion
2027-07-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

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 NCT05562167 on ClinicalTrials.gov