Last updated on March 2019

Inorganic Nitrite Delivery to Improve Exercise Capacity in HFpEF


Brief description of study

A randomized, double-blind, placebo-controlled crossover study to assess the effect of inorganic nitrite (NO2) on aerobic capacity (peak VO2) after four weeks of dosing. Approximately 100 participants will be enrolled in this 2*2 crossover study.

Detailed Study Description

Screen potential HFpEF patients for eligibility criteria and interest Study Visit 1 • Initiate consent process and obtain written informed consent. - Confirm with the participant that HF symptoms are the primary limitation to activity. If so, they proceed to CPET screening. If not, they are considered a screen fail. - Obtain baseline bloods *- CBC, complete chemistry panel, biomarkers, biorepository and genetics (if agreed to participate) . - Obtain CPET to verify patient eligibility peak VO2 ≤ 75% predicted and RER ≥ 1.0 (within 3 days prior to randomization) and establish baseline value. - Qualifying patients perform additional baseline studies: history, assess NYHA class, physical exam, ECG, and KCCQ. - Open label, single-dose run-in where patient receives maximal dose (80 mg) inhaled inorganic nitrite. Patients who do not tolerate the run-in are considered screen failures. - Randomize qualifying patients. - Dispense phase-1 study drug, nebulizers and accelerometers - Participants take no study drug for two weeks (baseline). - Participants take 46 mg study drug at a minimum of 4 hours apart, 3 times a day, during active part of the day for 7 days. - Participants take 80 mg study drug at a minimum of 4 hours apart, 3 times a day, during active part of the day until returning for study visit 2 (at least 42 days but up to 49 days post-baseline visit). - If side effects develop, participants can down-titrate to the previous dose. - Participants are called frequently to reinforce study procedures and assess compliance. Study Visit 2 (42-49 Days Post Study Visit 1) - Participant holds study drug on day of visit. - Review history, assess NYHA class, perform physical exam and KCCQ. - Obtain blood draws ** - CBC, complete chemistry panel, biomarkers, biorepository (if agreed to participate). - Obtain limited echocardiogram **. - Perform CPET with Study Drug administered immediately before starting the CPET (primary endpoint). - Change out accelerometer and dispense phase-2 study drug. - Participants take no study drug for two weeks (washout). - Participants take 46 mg study drug at a minimum of 4 hours apart, 3 times a day, during active part of the day for 7 days. - Participants take 80 mg study drug at a minimum of 4 hours apart, 3 times a day, during active part of the day until returning for study visit 3 (at least 42 but up to 49 days after study visit 2). - If side effects develop Participants can down-titrate to the previously tolerated dose. - Participants are called frequently to reinforce study procedures and assess compliance. Study Visit 3 (42-49 Days Post Study Visit 2) • Participant holds study drug on day of visit. - Review history, assess NYHA class, perform physical exam and KCCQ - Obtain blood draws** - CBC, complete chemistry panel, biomarkers, biorepository (if agreed to participate). - Obtain limited echocardiogram**. - Perform CPET with Study Drug administered immediately before starting the CPET (primary endpoint). - Return accelerometer and phase-2 study drug. - End of study drug (phase out). Phone Visit and End of Study (14 Days Post Study Visit 3) - A final phone visit is conducted to assess for adverse events. - Visit 1: baseline blood draw needs to be completed prior to the CPET (if this is not feasible, then they cannot be obtained for at least 3 hours post the CPET and prior to the run-in test dose). - Visit 2 and Visit 3: blood draws and limited echo need to be obtained prior to study drug administration (if this is not feasible, then it cannot be obtained for at least 3 hours post study drug administration)

Clinical Study Identifier: NCT02742129

Contact Investigators or Research Sites near you

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University of Missouri Health System

Columbia, MO United States
0.99miles

Recruitment Status: Closed


Brief Description Eligibility Contact Research Team


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