Stress and Congestive Heart Failure
The purpose of this study is to investigate whether acute stress can precipitate congestive heart failure (CHF) exacerbation in patients with CHF.
Conditions:
🦠 Congestive Heart Failure
🗓️ Study Start (Actual) 2 December 2020
🗓️ Primary Completion (Estimated) 1 January 2026
✅ Study Completion (Estimated) 1 January 2026
👥 Enrollment (Estimated) 112
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Hartford, Connecticut, United States
📍 Hartford, Connecticut, United States
📍 New Haven, Connecticut, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

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

    Exclusion Criteria:

    • * 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.
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 9 September 2020
  • First Submitted that Met QC Criteria 9 September 2020
  • First Posted 16 September 2020

Study Record Updates

  • Last Update Submitted that Met QC Criteria 17 July 2024
  • Last Update Posted 19 July 2024
  • Last Verified July 2024