RecruitingNot ApplicableNCT04551560

Stress and Congestive Heart Failure


Sponsor

Yale University

Enrollment

112 participants

Start Date

Dec 2, 2020

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this study is to investigate whether acute stress can precipitate congestive heart failure (CHF) exacerbation in patients with CHF.


Eligibility

Min Age: 18 Years

Inclusion Criteria1

  • Heart failure patients over 18 who have or will be receiving a Cardiomems implanted PAP monitor.

Exclusion Criteria6

  • Patients who are unable to perform EMA or laboratory assessments due to cognitive, visual, language, or other disabilities will be excluded.
  • Patients with Class IV heart failure will also be excluded, as they are already maximally decompensated, and a ceiling/floor effect would preclude effects of stress.
  • Patients with conditions other than heart failure that affect PA pressures (e.g. dialysis).
  • Patients with physical conditions that interfere with study participation.
  • Patients non-compliant with their PAP monitoring.
  • Patients with chronic opioid use will be excluded.

Interventions

OTHERMental Stress

Patients will undergo a lab mental stress protocol, and a field protocol using ecological momentary assessment (EMA) to test the effects of psychological stress and negative emotion on PAP in HF patients.


Locations(2)

St. Francis Hospital

Hartford, Connecticut, United States

Yale University

New Haven, Connecticut, United States

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NCT04551560


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