Actively Recruiting
Stress and Congestive Heart Failure
Led by Yale University · Updated on 2026-01-27
112
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
Sponsors
Y
Yale University
Lead Sponsor
N
National Heart, Lung, and Blood Institute (NHLBI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating whether acute psychological stress can trigger worsening of congestive heart failure (CHF) symptoms in patients with CHF. This study aims to understand the impact of stress and negative emotions on pulmonary artery pressure (PAP) and how stress-induced changes relate to heart failure exacerbations. It also seeks to identify risk factors that influence how patients respond to stress, including physiological and psychosocial factors. Participants will undergo a laboratory mental stress test and a field protocol using ecological momentary assessment (EMA). The laboratory session includes periods of rest, relaxation, stress, and recovery while monitoring PAP and blood pressure. Blood samples are taken to measure CHF-related biomarkers. In the field protocol, participants will monitor their PAP daily over six months and complete smartphone-based stress and sleep quality questionnaires. For one month, they will also complete evening assessments. During the study, participants complete psychosocial questionnaires online or on paper. Researchers review clinical outcomes through medical records and the Cardiomems Merlin database. The main outcome measured is pulmonary artery pressure over six months, with medication changes also tracked. The study involves ongoing monitoring and assessment to understand stress effects on heart failure progression.
CONDITIONS
Brief Title
Stress and Congestive Heart Failure
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Heart failure patients over 18 who have or will be receiving a Cardiomems implanted pulmonary artery pressure monitor.
You will not qualify if you...
- Patients unable to perform ecological momentary assessment or laboratory assessments due to cognitive, visual, language, or other disabilities.
- Patients with Class IV heart failure.
- Patients with conditions other than heart failure affecting pulmonary artery pressures (e.g., dialysis).
- Patients with physical conditions that interfere with study participation.
- Patients non-compliant with their pulmonary artery pressure monitoring.
- Patients with chronic opioid use.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants complete a laboratory mental stress protocol including resting, stress, and recovery periods while pulmonary artery pressure and blood pressure are monitored and psychosocial assessments are completed.
1 visit (in-person)
Duration - 6 months
Participants complete daily morning pulmonary artery pressure assessments and stress/emotion questionnaires via a smartphone app for 6 months. For one month, additional evening assessments and questionnaires are completed.
Daily morning assessments and questionnaires for 6 months, plus daily evening assessments and questionnaires for 1 month
Duration - Up to 6 months
Clinical outcomes are monitored through medical record review and the Cardiomems Merlin database, alongside baseline psychosocial questionnaires.
No additional visits; data collected through records and questionnaires
Trial Site Locations
Total: 2 locations
1
St. Francis Hospital
Hartford, Connecticut, United States, 06105
Actively Recruiting
2
Yale University
New Haven, Connecticut, United States, 06511
Actively Recruiting
Research Team
R
Rachel Lampert, MD
M
Matthew Burg
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
BASIC_SCIENCE
Number of Arms
1
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