Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2025-12-26 @ 4:48 AM
Study NCT ID:
NCT04551560
Status:
RECRUITING
Last Update Posted:
2025-05-02
First Post:
2020-09-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Stress and Congestive Heart Failure
Sponsor:
Yale University
Organization:
Study Overview
Official Title:
Stress and Congestive Heart Failure
Status:
RECRUITING
Status Verified Date:
2025-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to investigate whether acute stress can precipitate congestive heart failure (CHF) exacerbation in patients with CHF.
Detailed Description:
Study participants will be followed for 6 months. 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 quiet period (30 min) Relaxation (10min) Stress period (10min) Recovery (30min) follows the stress task followed by Neutral conversation (5min). PAP and blood pressure are assessed, and the participant completes a stress/mood likert assessment at the end of the rest period, stress, and 15min and 30min during recovery.
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 and 1 vial drawn at the end of rest, stress and twice during recovery.
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, 1-100 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.
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 quiet period (30 min) Relaxation (10min) Stress period (10min) Recovery (30min) follows the stress task followed by Neutral conversation (5min). PAP and blood pressure are assessed, and the participant completes a stress/mood likert assessment at the end of the rest period, stress, and 15min and 30min during recovery.
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 and 1 vial drawn at the end of rest, stress and twice during recovery.
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, 1-100 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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 1R01HL152548-01 | NIH | None | https://reporter.nih.gov/quic… | View |