Clinical Trials

Overview

About this study

The pilot study aims to recruit 60 subjects classified as New York Heart Assosciation (NYHA) class 1-2 HF patients (n = 15), NYHA class 2-3 HF patients (n = 15), HF patients admitted to the emergency room for treatment of fluid overload (n = 15), and healthy controls (n = 15). Breath samples will be collected form these patients using a ReCIVA Breath Sampler (Owlstone Medical Ltd.) to determine the levels of exhaled volatile organic compounds (VOCs). Following enrollment and study completion, study staff will access the participants’ clinic records to obtain information about their NYHA classification, blood biomarker levels, excess fluid status, and medication history, to account for confounding exhaled VOCs as a byproduct of medication metabolism. An analysis of variance (ANOVA) will be used to determine differences in exhaled VOCs between these NYHA groups. Additionally, a generalized additive mixed model (GAMM) will be used to examine the non-linear relationships between exhaled VOCs and blood biomarkers. We hypothesize the breath biopsy samples will be sensitive enough to identify exhaled volatile organic compounds (VOCs) in healthy heart failure (HF) patients. Further, we will be capable of utilizing these exhaled VOCs to develop a “breath print” to predict worsening clinical status.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Participating Mayo Clinic locations

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