- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04682769
Cardiac Markers in Depressed Patients With Coronary Heart Disease - R01HL147862 (TREND-3)
March 20, 2024 updated by: Washington University School of Medicine
Fatigue, Anhedonia and Cardiac Prognostic Markers in Depressed Patients With Coronary Heart Disease
Depression doubles the risk of death in patients with coronary heart disease (CHD), but so far, there is insufficient evidence that we can reduce the risk of death by treating depression.
This study will investigate the cardiac risk markers that are associated with depression symptoms that remain despite treatment, and identify potential targets for their treatment.
The results of the study will inform the development of more effective interventions to improve both depression and survival in patients with CHD.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
Depression is associated with an increased risk of cardiac morbidity and mortality in coronary heart disease (CHD).
Although safe and modestly effective treatments for major depression exist, only about 30% of patients ever achieve full remission.
CHD patients with depression symptoms that do not respond to treatment are at high risk for cardiac morbidity and mortality compared to those whose depression symptoms respond to treatment.
Anhedonia and fatigue are among the most common symptoms to remain following treatment in both depressed CHD patients and in medically well psychiatric patients.
In a recent study, the investigators found that several risk markers of cardiovascular morbidity and mortality including a high normal level of the thyroid hormone free thyroxine (FT4), low nocturnal heart rate variability, blunted circadian heart rate, and poor sleep quality predict depression treatment response and post-treatment symptoms of fatigue and anhedonia.
It is unclear why these risk markers are associated with residual anhedonia and fatigue.
Elevated cortisol levels, chronic sympathetic nervous system activation, reduced vagal modulation of HR, high levels of perceived stress, low level of physical activity, disordered sleep, and occult subclinical thyroid diseases are among the most plausible explanations.
Any or all of these factors may explain the relationship between the risk markers and residual fatigue and anhedonia, and all are potentially modifiable and thus possible targets for future clinical trials.
The purpose of the proposed research is to identify modifiable correlates of these risk markers and of fatigue and anhedonia in depressed patients with CHD.
Study participants will be recruited from cardiology practices at Washington University School of Medicine.
Potentially eligible patients will be scheduled for a structured clinical interview.
Those who score ≥ 14 on the BDI-II and meet the DSM-5 criteria for major depression and no exclusion criteria will be enrolled.
Participants will be evaluated by phone, or in person at the Behavioral Medicine Center at Washington University School of Medicine.
The evaluation will be performed in the morning.
An appointment will be made for a blood draw on a morning after a 12-hour fast to obtain a thyroid panel, lipid profile, plasma cortisol, C-reactive protein, and other biomarkers.
Participants will be fitted with an ambulatory ECG monitor and a wrist actigraph that will be sent to them, and they will complete a battery of self-report inventories.
The ECG monitor and actigraph will be worn for 48 hours on two consecutive weekdays to measure the ECG markers, activity levels, and sleep parameters.
Participants will be compensated for their time upon return of the samples and equipment.
This study will identify potential targets for adjunctive interventions to augment traditional depression treatments and thereby help to lay the groundwork for a randomized clinical trial to determine whether treating depression in patients with CHD can improve both depression and event-free survival.
Study Type
Observational
Enrollment (Estimated)
175
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Patricia A Herzing, RN
- Phone Number: 314-286-1360
- Email: herzingp@wustl.edu
Study Contact Backup
- Name: Jessica L Winker, MPH
- Phone Number: 314-286-1313
- Email: jessica.winker@wustl.edu
Study Locations
-
-
Missouri
-
Saint Louis, Missouri, United States, 63108
- Recruiting
- Washington University
-
Contact:
- Patricia A. Herzing, RN
- Phone Number: 314-286-1360
- Email: herzingp@wustl.edu
-
Contact:
- Jessica L. Winker, MPH
- Phone Number: 314-286-1313
- Email: jessica.winker@wustl.edu
-
Principal Investigator:
- Kenneth E Freedland, PhD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Participants with Coronary Disease and Depressive Disorder
Description
Inclusion Criteria:
- Patients seen at the Washington University Medical Center with coronary heart disease (CHD) documented by coronary angiography or history of acute coronary syndrome (ACS).
- On a stable medication regimen (only minor changes in drug or dosage in last 30 days) are eligible for recruitment.
- Meet the diagnostic criteria for a depressive disorder, score ≥ 14 on the Beck Depression Inventory (BDI-II), and not meet any exclusion criteria.
Exclusion Criteria:
- Thyroid disease or thyroid medications.
- Moderate to severe cognitive impairment.
- Major psychiatric comorbidities.
- Taking antidepressants other than a selective serotonin reuptake inhibitor (SSRI).
- Suicidal features.
- Current substance abuse.
- New York Heart Association (NYHA) class III or higher or a recent (<3 months) acute coronary syndrome (ACS), coronary artery bypass graft surgery, cardiac hospitalization, or cardiac-related emergency department visit.
- Advanced malignancy, a disability that would prevent compliance with the study protocol, or physician or patient refusal.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Patients with medically stable coronary heart disease and Depressive Disorder
|
Patients with Coronary Heart Disease and Depressive Disorder are receiving routine treatment by their physician.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
This is our primary measure of depression severity.
Time Frame: baseline contact
|
Beck Depression Inventory (BDI-II) scale 0-63; higher score indicates a more severe depression |
baseline contact
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Kenneth E Freedland, PhD, Washington University School of Medicine
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 1, 2020
Primary Completion (Estimated)
May 31, 2025
Study Completion (Estimated)
May 31, 2025
Study Registration Dates
First Submitted
December 10, 2020
First Submitted That Met QC Criteria
December 18, 2020
First Posted (Actual)
December 24, 2020
Study Record Updates
Last Update Posted (Actual)
March 21, 2024
Last Update Submitted That Met QC Criteria
March 20, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R01HL147862 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
De-identified study data will be shared on request after the closure of the study.
IPD Sharing Time Frame
The dataset is expected to be finalized in mid- to late-2025.
IPD Sharing Access Criteria
Affiliation with a recognized research institution
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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