Investigating the impact of stress on heart failure exacerbation
Stress and Congestive Heart Failure
This study is testing how sudden stress affects people with heart failure by looking at changes in their heart pressure and other factors over six months.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 112 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Yale University Academic / other |
| Locations | 2 sites (Hartford, Connecticut and 1 other locations) |
| Trial ID | NCT04551560 on ClinicalTrials.gov |
What this trial studies
This study aims to explore how acute stress affects patients with congestive heart failure (CHF) by monitoring changes in pulmonary artery pressure (PAP) during stress-inducing scenarios. Participants will undergo a laboratory mental stress protocol and ecological momentary assessment (EMA) over six months to assess the relationship between psychological stress and CHF exacerbation. The study will also identify predictors of individual responses to stress, including physiological and psychosocial factors. Blood samples will be collected to analyze CHF-related biomarkers throughout the study.
Who should consider this trial
Good fit: Ideal candidates are heart failure patients over 18 who have or will receive a CardioMEMS implanted pulmonary artery pressure monitor.
Not a fit: Patients with Class IV heart failure or those unable to participate in assessments due to cognitive or physical disabilities may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better management strategies for CHF patients by understanding how stress contributes to their condition.
How similar studies have performed: While the specific approach of this study may be novel, previous studies have indicated a relationship between stress and heart failure exacerbations, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Hartford, Connecticut and 1 other locations
- St. Francis Hospital — Hartford, Connecticut, United States (Recruiting)
- Yale University — New Haven, Connecticut, United States (Recruiting)
Study contacts
- Principal investigator: Rachel Lampert, MD — Yale University
- Study coordinator: Rachel Lampert, MD
- Email: rachel.lampert@yale.edu
- Phone: (203) 737-4068
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.