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INDIE-HFpEF


Title Inorganic Nitrate Delivery to Improve Exercise Capacity in HFpEF
Therapeutic Area Congestive Heart Failure
Principal Investigator Gordon Huggins, MD
Min Age 40 Years
Gender Both
Contact Nathan Yuen
617 636 4990
More Information https://clinicaltrials.gov/ct2/show/NCT02742129

Overview

The purpose of this study is to test if an investigational drug, Sodium Nitrite Solution (AIR-001) inhaled through a nebulizer (a hand held breathing device), is safe and can improve the ability to tolerate all forms of physical activity, including exercise, and thus improve quality of life in people who have chronic diastolic heart failure. "Investigational" means that the study drug is currently being tested in research studies and is not approved by the US Food and Drug Administration (FDA) for standard medical use to treat heart failure.

Study Details

Inclusion Criteria

  • Have heart failure with Preserved Ejection Fraction (HFpEF) (Current EF>50% and no history of EF<45%)
  • Heart failure is the primary factor in limiting activity due to shortness of breath and/or fatigue and/or chest pain
  • No Chronic nitrate therapy or not using intermittent sublingual nitroglycerin within last 7 days.
  • Exclusion Criteria

    • Recent (1 month) hospitalization for heart failure
    • GFR < 20 ml/min/1.73m2 within 90 days prior to randomization
    • Significant Chronic obstructive pulmonary disease thought to contribute to dyspnea
    • Study Requirements

      3 research visits, max length of participation: 98 days, 3 blood collectionsa nd each about 4 teaspoons (20ml), 2 Echos, 3 Cardiac pulmonary exercise tests (CPET)