Stress and Congestive Heart Failure
2 other identifiers
interventional
112
1 country
2
Brief Summary
The purpose of this study is to investigate whether acute stress can precipitate congestive heart failure (CHF) exacerbation in patients with CHF.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Dec 2020
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 9, 2020
CompletedFirst Posted
Study publicly available on registry
September 16, 2020
CompletedStudy Start
First participant enrolled
December 2, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2026
CompletedJanuary 27, 2026
January 1, 2026
5.4 years
September 9, 2020
January 26, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Pulmonary Artery Pressure
Pulmonary artery pressure as measured by an implanted monitor: Pulmonary artery pressure will be compared between times of stress and calm, in both the laboratory and real-life setting.
6 months
Secondary Outcomes (1)
Medication changes
6 months
Other Outcomes (1)
Number of participants that are hospitalized
6 months
Study Arms (1)
Mental Stress
OTHERPatients 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Heart failure patients over 18 who have or will be receiving a Cardiomems implanted PAP monitor.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Yale Universitylead
- National Heart, Lung, and Blood Institute (NHLBI)collaborator
Study Sites (2)
St. Francis Hospital
Hartford, Connecticut, 06105, United States
Yale University
New Haven, Connecticut, 06511, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Rachel Lampert, MD
Yale University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 9, 2020
First Posted
September 16, 2020
Study Start
December 2, 2020
Primary Completion
April 30, 2026
Study Completion
April 30, 2026
Last Updated
January 27, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will not share