Inorganic NItrate and EXercise Performance in Heart Failure (iNIX-HF): Dose Response
Status:
Recruiting
Trial end date:
2025-12-31
Target enrollment:
Participant gender:
Summary
The purpose of this study is to do the work that is necessary and sufficient for setting up
an appropriate multi-center, randomized clinical trial (RCT) of a new therapy for heart
failure: inorganic nitrate. The investigators will first determine the effects and
palatability of ~12.8mmol KNO3 (an oral pill) as compared to the roughly equivalent amount of
nitrate in 2 beetroot juice (BRJ) Sports Shots (by James White Drinks). Next, the
investigators will determine the effects of inorganic nitrate (KNO3 in an oral pill format)
on blood pressure, blood nitrate levels, breath nitric oxide (NO) levels, and exercise
performance in a dose-response study. Third, the investigators will perform a small phase II
chronic treatment study that will allow them to determine the best primary endpoint and the
numbers of patients the investigators will need to study in the large, multi-center RCT to
follow this project. In the small study and in the RCT to follow, the investigators will
determine whether inorganic nitrate can improve aerobic exercise capacity, muscle power, and
speed of muscle contraction, and lessen the effort of breathing during exercise.