Stress and Congestive Heart Failure
Primary Purpose
Congestive Heart Failure
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mental Stress
Sponsored by
About this trial
This is an interventional basic science trial for Congestive Heart Failure
Eligibility 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.
Sites / Locations
- St. Francis HospitalRecruiting
- Yale UniversityRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Mental Stress
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Medication changes
Will be compared between those with highest levels of stress-triggered PA increases, and those with lower
Full Information
NCT ID
NCT04551560
First Posted
September 9, 2020
Last Updated
October 12, 2023
Sponsor
Yale University
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
1. Study Identification
Unique Protocol Identification Number
NCT04551560
Brief Title
Stress and Congestive Heart Failure
Official Title
Stress and Congestive Heart Failure
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 2, 2020 (Actual)
Primary Completion Date
January 1, 2026 (Anticipated)
Study Completion Date
January 1, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congestive Heart Failure
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
112 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Mental Stress
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Mental Stress
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pulmonary Artery Pressure
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Medication changes
Description
Will be compared between those with highest levels of stress-triggered PA increases, and those with lower
Time Frame
6 months
Other Pre-specified Outcome Measures:
Title
Number of participants that are hospitalized
Description
Hospitalizations will be compared between those with highest levels of stress-triggered PA increases, and those with lower
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rachel Lampert, MD
Phone
(203) 737-4068
Email
rachel.lampert@yale.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Matthew Burg
Phone
203-932-5711
Ext
3268
Email
matthew.burg@yale.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rachel Lampert, MD
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Francis Hospital
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06105
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shannon Marsh, PA-C
Phone
860-714-6178
Email
shannon.marsh@trinityhealthofne.org
First Name & Middle Initial & Last Name & Degree
Jason Nall, PA-C
Email
jnall@trinityhealthofne.org
First Name & Middle Initial & Last Name & Degree
Sara Tabtabai, MD
Facility Name
Yale University
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06511
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rachel Lampert
Phone
203-737-4068
Email
rachel.lampert@yale.edu
12. IPD Sharing Statement
Plan to Share IPD
No
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Stress and Congestive Heart Failure
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