Stress and Congestive Heart Failure

The purpose of this study is to investigate whether acute stress can precipitate congestive heart failure (CHF) exacerbation in patients with CHF.

Study Overview

• Status: Recruiting
• Conditions: Congestive Heart Failure
• Intervention / Treatment: Other: Mental Stress

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.

• Study Type: Interventional
• Enrollment (Estimated): 112
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rachel Lampert, MD; Phone Number: (203) 737-4068; Email: rachel.lampert@yale.edu
• Study Contact Backup: Name: Matthew Burg; Phone Number: 3268 203-932-5711; Email: matthew.burg@yale.edu

Study Locations

• United States
  • Connecticut
    • Hartford, Connecticut, United States, 06105
      • Recruiting
      • St. Francis Hospital
      • Contact: Shannon Marsh, PA-C; Phone Number: 860-714-6178; Email: shannon.marsh@trinityhealthofne.org
      • Contact: Jason Nall, PA-C; Email: jnall@trinityhealthofne.org
      • Principal Investigator: Sara Tabtabai, MD
    • New Haven, Connecticut, United States, 06511
      • Recruiting
      • Yale University
      • Contact: Rachel Lampert; Phone Number: 203-737-4068; Email: rachel.lampert@yale.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Mental Stress; 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.	Other: Mental Stress; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Medication changes	Will be compared between those with highest levels of stress-triggered PA increases, and those with lower	6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants that are hospitalized	Hospitalizations will be compared between those with highest levels of stress-triggered PA increases, and those with lower	6 months

Collaborators and Investigators

• Sponsor: Yale University
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
• Investigators: Principal Investigator: Rachel Lampert, MD, Yale University

Study record dates

Study Major Dates

• Study Start (Actual): December 2, 2020
• Primary Completion (Estimated): January 1, 2026
• Study Completion (Estimated): January 1, 2026

Study Registration Dates

• First Submitted: September 9, 2020
• First Submitted That Met QC Criteria: September 9, 2020
• First Posted (Actual): September 16, 2020

Study Record Updates

• Last Update Posted (Actual): October 13, 2023
• Last Update Submitted That Met QC Criteria: October 12, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: 2000027107; 1R01HL152548-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No