Coronary Heart DiseaseTREND-3NCT04682769
Cardiac Markers in Depressed Patients With Coronary Heart Disease - R01HL147862
An observational study of Coronary Heart Disease and Depression, run by Washington University School of Medicine at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Heart Disease, Depression
- What is being tested?
- Other
- How many people
- 175 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2020to 31 May 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants with Coronary Disease and Depressive Disorder
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Coronary Heart Disease, Depression
- Being tested
- Other
- Medical subject headings
- Coronary Disease, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OtherOther
Patients with Coronary Heart Disease and Depressive Disorder are receiving routine treatment by their physician.
| Study group | Role | What they receive |
|---|---|---|
| Patients with medically stable coronary heart disease and Depressive Disorder | Not described Receives: Other: Other |
What is being measured
The primary outcome is the main question the study is designed to answer.
This is our primary measure of depression severity.
Beck Depression Inventory (BDI-II)
scale 0-63; higher score indicates a more severe depression
Measured: baseline contact
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2020
- Study start1 Dec 2020
- Primary completion25 Jan 2025
- Study completion31 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Heart DiseaseStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 175 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kenneth E Freedland, PhD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04682769
- Sponsor's protocol ID
- R01HL147862
- Acronym
- TREND-3
- Status last verified
- Dec 2025
- First submitted
- 10 Dec 2020
- Last updated
- 24 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified study data will be shared on request after the closure of the study.
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fatigue, Anhedonia and Cardiac Prognostic Markers in Depressed Patients With Coronary Heart Disease
- ClinicalTrials.gov ID
- NCT04682769
- Acronym / sponsor ID
- TREND-3 / R01HL147862
- Conditions
- Coronary Heart Disease, Depression
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 175 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 25 Jan 2025 (actual)
- Study completion
- 31 May 2025 (actual)
- First posted
- 24 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with medically stable coronary heart disease and Depressive Disorder | – | Other: Other |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants with Coronary Disease and Depressive Disorder
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OtherPatients with Coronary Heart Disease and Depressive Disorder are receiving routine treatment by their physician. | Other | Patients with medically stable coronary heart disease and Depressive Disorder |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2025.
- Individual participant dataSharing planned: Yes. De-identified study data will be shared on request after the closure of the study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kenneth E Freedland, PhD principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Heart Disease and Depression, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
This is our primary measure of depression severity. (time frame: baseline contact). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2025.