RECRUITING

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

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Conditions

Heart Failure

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

The Inorganic Nitrate and eXercise Performance in Heart Failure (iNIX-HF) -a Phase II Clinical Trial

Quick Facts

Study Start:2023-03-31
Study Completion:2028-01-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05562167

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:19 Years to 79 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Diagnosis of heart failure with reduced ejection fraction; New York Heart Association (NYHA) Class II-III; Ejection fraction less than 45% as determined on an imaging study within 3 months of enrollment.
  2. * Stable medical therapy, defined by no addition or removal (or change of more than 100 percent) of the following: beta-adrenergic blockade and angiotensin converting enzyme (ACE) inhibitors or angiotensin receptor blocker (ARB or aldosterone antagonists) or ARNI (ARB + sacubitril) for 60 days.
  1. * Vulnerable populations as defined by the U.S. Department of Health and Human Services; prisoners and children will be excluded from this study
  2. * Pharmacologic, organic nitrate therapy within the last 3 months
  3. * Major orthopedic, psychiatric, neurological, or other conditions that would hinder the ability to complete the exercise tests
  4. * Estimated glomerular filtration rate less than 45 mL/min on screening clinical laboratories
  5. * Systolic blood pressure less than 90mmHg or greater than 180mmHg at screening; Diastolic blood pressure less than 40mmHg or greater than 100mmHg at screening
  6. * Previous adverse reaction to nitrate necessitating withdrawal of therapy; Treatment with phosphodiesterase inhibitors within the last 3 months (patient must also be willing to not take them for the duration of the trial)
  7. * Ejection fraction greater than or equal to 45%
  8. * Primary hypertrophic cardiomyopathy; Infiltrative cardiomyopathy (e.g., amyloid); Active myocarditis; Complex congenital heart disease;
  9. * Active collagen vascular disease;
  10. * Percutaneous coronary intervention, new bi-ventricular pacing, or coronary artery bypass grafting within the past 3 months
  11. * Valvular heart disease with severe regurgitation or stenosis of any valve
  12. * Acute or chronic severe liver disease as evidenced by encephalopathy or variceal bleeding
  13. * Terminal disease (other than heart failure) with expected survival less than 1 y
  14. * Enrollment in another therapeutic trial during the period of the study
  15. * Pregnant women; Postmenopausal women taking exogenous estrogen replacement therapy
  16. * Patients requiring exogenous oxygen at rest or during exercise
  17. * Patients with active angina or ischemia due to epicardial coronary disease
  18. * Patients taking xanthine oxidase inhibitors will be excluded
  19. * Individuals taking proton pump inhibitors, antacids will be asked to hold these medications for the duration of the study if approved by his/her physician.

Contacts and Locations

Study Contact

Lauren K Park, PhD
CONTACT
3143633915
l.park@wustl.edu
Susan B Racette, PhD
CONTACT
602-543-1563
Susan.Racette@asu.edu

Principal Investigator

Linda R Peterson, MD
PRINCIPAL_INVESTIGATOR
Washington University School of Medicine
Lauren K Park, PhD
STUDY_DIRECTOR
Washington University School of Medicine

Study Locations (Sites)

Washington University School of Medicine
Saint Louis, Missouri, 63110
United States

Collaborators and Investigators

Sponsor: Washington University School of Medicine

  • Linda R Peterson, MD, PRINCIPAL_INVESTIGATOR, Washington University School of Medicine
  • Lauren K Park, PhD, STUDY_DIRECTOR, Washington University School of Medicine

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-03-31
Study Completion Date2028-01-01

Study Record Updates

Study Start Date2023-03-31
Study Completion Date2028-01-01

Terms related to this study

Additional Relevant MeSH Terms

  • Heart Failure