Exhaled Biomarkers for Heart Failure

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.

Inclusion Criteria:

  • Adults over the age of 21 and who are willing and able to give informed consent.
  • Diagnosed with CHF and presenting to Mayo Clinic for HF clinic visits.
  • Classified as NYHA Class I-IV within the past 12 months.

Exclusion Criteria: 

  • Under the age of 21.
  • Physical or cognitive limitations that would prevent patient from applying or using the device properly.
  • Women who are known to be pregnant or plan to become pregnant within the course of this study.
  • Has known allergies to silicone based adhesive or skin breakdown in areas where device placement is required.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Bruce Johnson, Ph.D.

Closed-enrolling by invitation

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"Close"
Not open to everyone who meets the eligibility criteria, but only those invited to participate by the study team.

Contact information:

Eli Kelley

(507) 538-4216

Kelley.Eli@mayo.edu

More information

Publications

Publications are currently not available