RecruitingPhase 2

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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
19 Years to 79 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Visits mentioned: 1 visit, 4 visits
  • Procedures mentioned: Questionnaires, Physical exams

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Health questionnaire 3."
  • "Physical examination 8."
  • "Visit 3 - Acute Dose Administration This visit will occur within 1 month after Visit 2."
  • "Between Visits 3 and 4 Between visits 3 and 4, participants will take the study medication provided daily."
  • "Every 2 weeks, participants will be asked to complete a Bi-weekly Adherence Survey to track compliance between Visits 3 and 4."
  • "Physical exam 9."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether potassium nitrate (KNO3) helps adults with heart failure build thigh muscle power and do better during exercise. It compares KNO3 with a placebo, a treatment with no active drug, after one dose and after 6 weeks of daily doses. It is for people whose heart pumps less blood than normal.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be age 18 to 79.
  • Have heart failure with reduced pumping strength and mild to moderate limits on physical activity (NYHA Class II–III).
  • Have a heart ultrasound showing an ejection fraction below 45%. This is the share of blood the heart pumps out with each beat.
  • For 60 days before the first visit, have no listed heart failure medicine added or stopped, and no dose change greater than 100%.
  • Be able and willing to sign the study consent form yourself. Someone else cannot sign for you.
  • If you or your partner could become pregnant, agree to avoid sex or use at least two approved birth control methods during the study and for 48 hours after treatment ends.

Who can't join

  • Be in a protected group excluded by the study, including children and prisoners, or be enrolled in another treatment trial.
  • Have used organic nitrate medicines or phosphodiesterase inhibitors in the past 3 months, or have had a bad reaction to nitrates. You must also avoid phosphodiesterase inhibitors during the study.
  • Have kidney filtering below 45 on the screening test; a top blood pressure number below 90 or above 180; or a bottom number below 40 or above 100.
  • Have certain heart muscle diseases, active heart muscle swelling, a complex heart defect present from birth, or a severely leaky or narrowed heart valve. Recent heart artery treatment, bypass surgery, or new pacing of both lower heart chambers also excludes you if done within 3 months.
  • Have chest pain from poor heart blood flow, poor blood flow caused by disease in the main heart arteries, need extra oxygen, or have a condition that would prevent you from completing exercise tests.
  • Have active collagen vascular disease, which affects connective tissues; severe liver disease with brain effects or bleeding from swollen veins; or another terminal illness with expected survival under 1 year.
  • Be pregnant, breastfeeding, or taking estrogen replacement after menopause. The study requires a negative urine pregnancy test and confirmation that you are not breastfeeding.
  • Take xanthine oxidase inhibitors, or be unable to stop proton pump inhibitors or antacids during the study. Tums is allowed except during the 5 days before visits 2, 3, and 4.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria To participate in this study, a patient must meet all of the criteria listed below: * Males and females aged greater than or equal to 18y and less than 80y at time of consent * Diagnosis of heart failure with reduced ejection fraction * New York Heart Association (NYHA) Class II-III at Visit 1 * Ejection fraction less than 45%, as evaluated through transthoracic echocardiography at Visit 1 * Stable medical therapy, defined by no addition or removal (or change of more than 100 percent) of the following for 60 days prior to Visit 1: beta-adrenergic blockade and angiotensin converting enzyme (ACE) inhibitors or angiotensin receptor blocker (ARB or aldosterone antagonists) or ARNI (ARB + sacubitril) * Ability and willingness to sign an IRB approved written informed consent form; legally authorized representatives are not allowed in this study Exclusion Criteria To participate in this study, a patient must not meet any of the criteria listed below: * Vulnerable populations as defined by the U.S. Department of Health and Human Services; prisoners and children will be excluded from this study * Pharmacologic, organic nitrate therapy within 3 months prior to Visit 1 * Major orthopedic, psychiatric, neurological, or other conditions that would hinder the ability to complete the exercise tests at the time of Visit 1 * Estimated glomerular filtration rate less than 45 mL/min/1.73m2 on screening clinical laboratories measured at Visit 1 * Systolic blood pressure less than 90mmHg or greater than 180mmHg at Visit 1 * Diastolic blood pressure less than 40mmHg or greater than 100mmHg at Visit 1 * Previous adverse reaction to nitrate prior to Visit 1 * Treatment with phosphodiesterase inhibitors within the last 3 months prior to Visit 1; Patient must also be willing to not take them for the duration of the trial * Diagnosis of primary hypertrophic cardiomyopathy, infiltrative cardiomyopathy (e.g., amyloid), active myocarditis, or complex congenital heart disease prior to Visit 1 * Active collagen vascular disease at time of Visit 1 * Percutaneous coronary intervention, new bi-ventricular pacing, or coronary artery bypass grafting within the 3 months prior to Visit 1 * Valvular heart disease with severe regurgitation or stenosis of any valve, as demonstrated on the echocardiogram at Visit 1 * Known severe liver disease as evidenced by encephalopathy or variceal bleeding; * Terminal disease (other than heart failure) with expected survival less than 1 y at time of Visit 1 * Enrollment in another therapeutic trial at time of Visit 1 * Pregnant and breastfeeding women or postmenopausal women taking exogenous estrogen replacement therapy at time of Visit 1 * To meet this criterion, patients must have a negative urine pregnancy test and provide verbal confirmation that they are not breastfeeding at time of Visit 1. * Note, post-menopausal is defined as last menstrual period occurring greater than or equal to 12 months prior to Visit 1 or confirmation of prior bilateral oophorectomy at least 6 months prior to first dose of study drug. * Women of childbearing potential or men with childbearing potential partners must agree that the participant and/or their partner will use at least two of the following highly effective method of birth control from study entry until 48 hours after completing study therapy, if not abstaining from sexual activity: * Barrier method contraception (e.g., male or female condoms with or without a spermicidal agent, diaphragm, or cervical cap with spermicide) * Stable dose of injectable, depot, oral, implanted, intravaginal, or transdermal hormonal contraception for at least 30 days before sexual activity * Intrauterine device (IUD) with or without hormones * Surgical sterilization * For women, this includes hysterectomy, bilateral oophorectomy with or without hysterectomy, or bilateral tubal ligation, bilateral salpingectomy, completed at least 6 months before first dose of study drug. * For men, this includes vasectomy. * Patients requiring exogenous oxygen at rest or during exercise prior to Visit 1 * Patients with active angina at time of Visit 1 or ischemia due to epicardial coronary disease prior to or at time of Visit 1 * Patients taking xanthine oxidase inhibitors at time of Visit 1 * Individuals taking proton pump inhibitors and/or antacids at time of Visit 1, if unable to stop these medications for the duration of the study. * Note, while patients will be asked to refrain from taking these medications for the duration of the study, they may take tums. However, patients must discontinue Tums for 5 days prior to study visits 2, 3, and 4.

Study sites (1)

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