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

Part of paid clinical trials in St Louis, Missouri.

Sponsor
Washington University School of Medicine
Study ID
NCT05562167
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
19 Years - 79 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Mar 31, 2023
Status verified
May 2026
Primary completion
May 31, 2027
Completion
Jul 31, 2027

Study Design

Enrollment
75 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Potassium Nitrate (KNO3) treatment arm
    10 mmol of KNO3 via a single gel capsule to be consumed orally once per day for 6 weeks.
  • Placebo Comparator: Placebo-controlled arm
    10 mmol of placebo via a single gel capsule to be consumed orally once per day for 6 weeks.

Primary Outcome Measure

VO2 Peak Testing [ Time Frame: Determined at Baseline visit, Acute Dose Visit, and Chronic Dose Visit, which will be scheduled throughout 8 weeks. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Washington University School of MedicineSt LouisMissouri63110
Dawson A Haley, B.S.
[email protected]
314-791-4455
Linda R Peterson, MD
[email protected]
314-362-4577
Linda R Peterson, MD (PRINCIPAL_INVESTIGATOR)
Andrew Coggan, PhD (SUB_INVESTIGATOR)

Find similar trials in St Louis, MO

By condition
Heart failure
By specialty
CardiologyHeart disease
By research site
Washington University School of Medicine· St Louis, MO

Related Studies