The inorganic nitrate and exercise performance in heart failure (inix-HF): - a phase II clinical trial

Active Project Grant Awarded Last action

Award ID
R33HL155858
Recipient
Awarding agency
Obligated
$3,607,120

Award facts

Assistance listing
93.837 Cardiovascular Diseases Research
Completion date 85% complete
Place of performance
St. Louis, MO 63110, USA

Award details come from USAspending.gov.

Description

Abstract
Heart failure with reduced ejection fraction (hfref) affects ~3 million people in the U.S. And is a mortal and morbid disease. Hfref impairs a patient's ability to exercise and perform activities of daily living. Although weak cardiac pumping ability clearly contributes to chronic disability associated with hfref, abnormal skeletal muscle function in patients with hfref is also a key debilitating factor. Skeletal muscle is therefore a vital target for treatment of hfref. Dietary inorganic nitrate enhances aerobic exercise capacity and muscle power in patients with hfref, as demonstrated in our preliminary studies. The overarching aim of the proposed clinical trial is to determine whether inorganic nitrate in a once-a-day oral gelcap format, offers a new, safe, and effective treatment for ameliorating the impaired exercise performance due to hfref. The aim of the R61 component of this grant is to set up the infrastructure necessary for the phase II clinical trial and to begin the trial. This includes compounding the inorganic nitrate (KNO3)/placebo capsules and all safety testing, obtaining institutional review board approval, clinicaltrials.GOV registration, redcap database development, recruitment enhancement core (REC) engagement, clinical translational research unit (ctru) project approval, enrollment and assessment and dose administration of the first subjects. The aims of the R33 component 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 (VO2PEAK) in patients with hfref (left ventricular ejection fraction

Transactions

Action Obligated Date
Amendment $0
Amendment $708,812
Amendment $740,803
Amendment $0
Amendment $341,565
Amendment $341,565
Amendment $737,188
Original award $737,188

Subawards

Subrecipient Amount Awarded
Trustees Of Indiana University Statement of work – IUPUIsubcontract from Washington University in St. Louis for “The Inorganic Nitrate and eXercise performance in Heart Failure (iNIX-HF) –… $155,988
Saint Louis University Scope of Work Saint Louis University The Inorganic Nitrate and eXercise performance in Heart Failure (iNIX-HF): - a phase II clinical trial Dr. Mikhalkova’s… $8,334
Arizona State University Scope of Work Project Title: The Inorganic Nitrate and eXercise performance in Heart Failure (iNIX-HF): - a phase II clinical trial Subrecipient PI and… $12,083
Arizona State University $2,591
Trustees Of Indiana University Statement of work – IUPUIsubcontract from Washington University in St. Louis for “The Inorganic Nitrate and eXercise performance in Heart Failure… $125,301
Saint Louis University Scope of Work Saint Louis University The Inorganic Nitrate and eXercise performance in Heart Failure (iNIX-HF): - a phase II clinical trial Dr.… $9,090
Arizona State University Scope of Work Project Title: The Inorganic Nitrate and eXercise performance in Heart Failure (iNIX-HF): - a phase II clinical trial Subrecipient PI and… $12,337
Saint Louis University Scope of Work Saint Louis University The Inorganic Nitrate and eXercise performance in Heart Failure (iNIX-HF): - a phase II clinical trial Dr.… $9,090
Arizona State University Scope of Work Project Title: The Inorganic Nitrate and eXercise performance in Heart Failure (iNIX-HF): - a phase II clinical trial For the proposed R61/R33… $11,904
Trustees Of Indiana University Statement of work – IUPUIsubcontract from Washington University in St. Louis for “The Inorganic Nitrate and eXercise performance in Heart Failure… $159,684

Quick answers

Who received award R33HL155858?

R33HL155858 was awarded to The Washington University by National Heart Lung and Blood Institute (National Institutes of Health) on August 1, 2022.

How much is award R33HL155858 worth?

$3,607,120 has been obligated on R33HL155858.

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