Stress and Congestive Heart Failure
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Congestive Heart Failure
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Basic Science
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
Patients will undergo a laboratory mental stress protocol, and a field protocol using ecological momentary assessment (EMA) to, 1) test the effects of psychological stress and negative emotion on pulmonary artery pressure (PAP) in HF patients; 2) examine the relationship of stress-induced PAP change...
Patients will undergo a laboratory mental stress protocol, and a field protocol using ecological momentary assessment (EMA) to, 1) test the effects of psychological stress and negative emotion on pulmonary artery pressure (PAP) in HF patients; 2) examine the relationship of stress-induced PAP change to HF exacerbation; and 3) identify a risk profile by exploring predictors of heterogeneity in the PAP response to stress, including physiological variables (e.g., NYHA class, biomarkers), sleep, quality, and psychosocial variables (e.g., sources of chronic stress, anger/hostility, depression. Patients will also undergo a battery of psychosocial questionnaires either online or paper as they prefer. Laboratory Component HF patients with existing or newly implanted with a CardioMEMS PAP monitor will complete the laboratory stress protocol, in the Hospital Research Unit (HRU) or other YCCI outpatient sites. Resting Baseline (10min). Stress period (10min) Recovery (30min) follows the stress task. PAP and blood pressure are assessed, and the participant completes a stress/mood likert assessment at 15min and 30min. Blood drawing: 10 ml of blood will be drawn for a panel of CHF-related biomarkers either at the beginning of the laboratory session or in a clinic visit. Field Component: For this phase, they will complete PAP assessment in the morning for six months, following their standard clinical protocol for daily monitoring (standard of care). In addition, at the time of the morning PAP assessment they will complete eDiary-based EMA via likert style questions (e.g., on an anchored, 1-10 scale) concerning the quality of their sleep the night before, the level of stress they are currently experiencing, and their emotional state. For one month, they will complete an additional evening PAP assessment, (extra, not standard of care) at which time they will complete similar eDiary-based likert style questions concerning the stressfulness of their day and the sources of stress (if any) they have experienced. All questions will be completed using the smartphone based EMA 'app' that the team has used and are currently using in NIH funded studies. Follow up - Clinical outcomes will be determined through review of the Cardiomems Merlin database and medical record review & Baseline psychosocial questionnaires
Tracking Information
- NCT #
- NCT04551560
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Investigators
- Not Provided