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
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
-
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
More Related Trials
-
Inhaled Sodium Nitrite on Heart Failure With Preserved Ejection Fraction
NCT02262078 ·Status: COMPLETED ·Phase: PHASE2
-
Treatment of HFpEF With Nitrate Supplement
NCT03289481 ·Status: COMPLETED ·Phase: EARLY_PHASE1
-
Effect of KNO3 Compared to KCl on Oxygen UpTake in Heart Failure With Preserved Ejection Fraction (KNO3CK OUT HFPEF)
NCT02840799 ·Status: COMPLETED ·Phase: PHASE2
-
Oral Nitrite for Older Heart Failure With Preserved Ejection Fraction
NCT02918552 ·Status: COMPLETED ·Phase: PHASE2
-
Vasodilator Therapy for Heart Failure and Preserved Ejection Fraction
NCT01516346 ·Status: COMPLETED ·Phase: PHASE2
-
A Study of Continuous Infusions of HNO (Nitroxyl) Donor in Patients With Heart Failure and Impaired Systolic Function
NCT03357731 ·Status: COMPLETED ·Phase: PHASE2
-
Effects of Dietary Nitrate Supplementation on Cardiorespiratory Control in Chronic Heart Failure
NCT02401126 ·Status: COMPLETED ·Phase: PHASE4
-
A Study of Oral Nitrate in Adults With Pulmonary Hypertension With Heart Failure and Preserved Ejection Fraction
NCT02980068 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Assess Safety and Efficacy of a Novel Patch Infusor Device and Novel SUBCUTaneous Furosemide Formulation Combination in Patients With Heart Failure
NCT04846816 ·Status: COMPLETED ·Phase: PHASE1
-
Matching Perfusion and Metabolic Activity in HFpEF
NCT04913805 ·Status: RECRUITING ·Phase: PHASE2
-
SGLT2i and KNO3 in HFpEF - The SAK HFpEF Trial
NCT05138575 ·Status: RECRUITING ·Phase: PHASE2
-
A Study to Develop Additional Safety and Clinical Experience With NATRECOR hBNP (Nesiritide) in the Treatment of Patients With Worsening Congestive Heart Failure Who Require Inpatient Intravenous Therapy With Medications That Influence the Tone and Caliber of Blood Vessels
NCT00271557 ·Status: COMPLETED ·Phase: PHASE3
-
0.5M Na Lactate Solution in Acute Heart Failure (AHF)
NCT01981655 ·Status: COMPLETED ·Phase: PHASE2
-
Nitrate's Effect on Activity Tolerance in Heart Failure With Preserved Ejection Fraction
NCT02053493 ·Status: COMPLETED ·Phase: PHASE2
-
Selective PDE9 Inhibition With IMR-687 in Adults With Heart Failure With Preserved Ejection Fraction
NCT05312021 ·Status: WITHDRAWN ·Phase: PHASE2
-
Study to Evaluate Effects of INL1 in Patients With Heart Failure and Reduced Ejection Fraction
NCT03875183 ·Status: UNKNOWN ·Phase: PHASE2
-
Initiation of ARNi and SGLT2i in Patients With HFrEF
NCT05989503 ·Status: COMPLETED ·Phase: PHASE4
-
Evaluate the Safety and Efficacy of 48-Hour Infusions of HNO (Nitroxyl) Donor in Hospitalized Patients With Heart Failure
NCT03016325 ·Status: COMPLETED ·Phase: PHASE2
-
A Phase II Trial to Assess Hemodynamic Effects of Istaroxime in Pts With Worsening HF and Reduced LV Systolic Function
NCT00616161 ·Status: COMPLETED ·Phase: PHASE2
-
Evaluate Efficacy, Safety and Tolerability of JTT-861 in Subjects With Heart Failure With Reduced Ejection Fraction
NCT06017609 ·Status: COMPLETED ·Phase: PHASE2
-
Sodium Glucose Co-Transporter 2 (SGLT2) and STEMI
NCT05305911 ·Status: RECRUITING ·Phase: PHASE2
-
Use of a Novel SUBCUTaneous Preparation of Furosemide to Facilitate Early Supported Discharge of Patients With Heart Failure
NCT05419115 ·Status: COMPLETED ·Phase: PHASE2
-
The Pharmacokinetic Study of the Combination of Digoxin and Polythylene Glycol Loxenatide Injection in Healthy Subjects
NCT02451527 ·Status: COMPLETED ·Phase: PHASE1
-
Real-world Research : Assessment of Effect of Combination of Drugs in the Treatment of Heart Failure
NCT06158711 ·Status: NOT_YET_RECRUITING
-
Study of JK07 in Subjects With Heart Failure With Reduced Ejection Fraction (HFrEF)
NCT04210375 ·Status: COMPLETED ·Phase: PHASE1