Recruitment

Recruitment Status
Active, not recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Heart Failure
  • Heart Failure With Preserved Ejection Fraction
  • Heart Failure With Reduced Ejection Fraction
Type
Observational
Design
Observational Model: CohortTime Perspective: Prospective

Participation Requirements

Age
Between 18 years and 99 years
Gender
Both males and females

Description

Heart failure (HF) is a complex clinical syndrome that results from any structural or functional impairment of the heart that affects the filling or ejection of blood in a cardiac cycle. HF manifests clinically as fatigue and dyspnea (shortness of breath). This may in turn result in exercise intoler...

Heart failure (HF) is a complex clinical syndrome that results from any structural or functional impairment of the heart that affects the filling or ejection of blood in a cardiac cycle. HF manifests clinically as fatigue and dyspnea (shortness of breath). This may in turn result in exercise intolerance and fluid retention. Fluid retention leads to pulmonary congestion and/or peripheral edema [Yancy, 2017]. Cardiac rhythm abnormalities are very common among HF patients. Any new abnormalities that arise in a patient with fluid decompensation prolongs hospitalization as well as increases mortality rates [Lloyd-Jones, 2010; Ross, 2009; Chaudhry, 2015]. Within 5 years of a HF diagnosis, the mortality rate is 50%. The 30 day, 1-year and 5-year mortality rates after HF related hospitalization were 10.4%, 22 % and 42.3 % respectively. Post discharge mortality increased from 4.3% to 6.4% between 1993 and 2005 [Lloyd-Jones, 2010; Ross, 2009]. In 2006, the number of deaths with a mention of HF was as high as it was in 1995. 1 out of every 9 mortalities in the US has HF mentioned as a cause. HF related deaths are approximately 7% of all cardiovascular diseases. In the US, HF related costs exceeded $30 billion in 2013. The average cost per patient for HF related hospitalization was $23,077. Hospitalization after a HF diagnosis happens at least once in 83% of the patients and up to four times in 43% of the patients [Yancy, 2017; Lloyd-Jones, 2010; Ross, 2009]. Heart sounds, and particularly the third heart sound, are well known as specific a very specific clinical signs for heart failure and are associated with worse clinical outcomes. In the context of HF the presence of a pronounced or audible S3 is a specific sign of elevated filling pressures and is suggestive of a restrictive filling pattern with a steep transmitral E-wave [Siejko, 2017]. Recent advances in digital audio technology allow us to not simply assess for the presence or absence of a third heart in objective measures, but also allow us to quantitate it [Buck, 2017; Adamson, 2014; Lloyd, 2019]. Further, recent work has demonstrated that if a frequency range to detect and quantitate the third heart sound is used that extends below the usual range for human hearing, that the third heart sound may be even more predictive of clinical outcomes. The investigators are working with a device manufacturer who have a wearable diagnostic device that includes a directional microelectronic machine microphone that can effectively detect heart sounds. This device will be used to detect and quantitate heart sounds, and specifically the third heart sound, to investigate the prognostic implications of a third heart sound.

Tracking Information

NCT #
NCT04112849
Collaborators
Not Provided
Investigators
Principal Investigator: John Boehmer, MD Milton S. Hershey Medical Center