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| ID | Type | Description | Link |
|---|---|---|---|
| R01MH063211 | U.S. NIH Grant/Contract | View source | |
| DATR A4-GPX |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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This study will examine the effect of antidepressant medication on rates of death and disease in depressed people with chronic heart failure.
Comorbid depression in people with chronic medical illness is a serious public health concern. Depressive disorders lead to increased morbidity, mortality, and poorer outcomes in ischemic heart disease, a leading cause of chronic heart failure (CHF). Evidence suggests that a relationship exists between depression and CHF; studies that examine the way CHF is affected by depression treatments are needed.
Participants in this study will be randomly assigned to receive either sertraline or placebo for 12 weeks. Assessments will be made at Weeks 2, 4, 6, 8, 10, and 12. Participants who do not respond to their treatment will have their medication dose adjusted following assessment. Interviews and rating scales will be used to assess depressive symptoms, cognitive status, psychiatric comorbidity, daily and chronic stress, and social support. A follow-up visit will take place 6 months, 1 year, 2 years, and 3 years after study completion.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sertraline | Experimental | Participants will take sertraline for 12 weeks |
|
| Placebo | Placebo Comparator | Participants will take placebo for 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sertraline | Drug | Dosage ranging from 50 mg to 200 mg once a day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Symptoms of Depression in Congestive Heart Failure Patients With Clinical Depression After Treatment With Sertraline or Placebo | Symptoms of depression (as measured by the Hamilton Depression Rating Scale, HDRS) in congestive heart failure patients with clinical depression after treatment with sertraline or placebo. The 17-item Hamilton Depression Rating Scale (HDRS) is a rater-administered assessment of depression severity, with total score ranges from 0 (not at all depressed) to 52 (most severely depressed). Change in depression was measured as the difference between the 12-week HDRS scores and the baseline HDRS scores. Thus, a negative value reflects an improvement in depressive symptoms over the 12-week period. | Measured at Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Cardiac Events and Morbidity / Mortality, Including Rehospitalization, in Congestive Heart Failure Patients With Depression After Treatment With Sertraline or Placebo. | Composite cardiovascular scores are calculated for each participant using recorded cardiac events, morbidity/mortality, rehospitalization, and discontinuation due to cardiovascular events. Composite score is compared for sertraline and placebo treatment groups. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ranga Krishnan, PhD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke Medical Center | Durham | North Carolina | 27710 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20723799 | Result | O'Connor CM, Jiang W, Kuchibhatla M, Silva SG, Cuffe MS, Callwood DD, Zakhary B, Stough WG, Arias RM, Rivelli SK, Krishnan R; SADHART-CHF Investigators. Safety and efficacy of sertraline for depression in patients with heart failure: results of the SADHART-CHF (Sertraline Against Depression and Heart Disease in Chronic Heart Failure) trial. J Am Coll Cardiol. 2010 Aug 24;56(9):692-9. doi: 10.1016/j.jacc.2010.03.068. | |
| 26186432 | Derived |
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Recruitment began in November, 2003 and concluded in March, 2008. Subjects were recruited from cardiology inpatient units as well as outpatient cardiology clinics.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sertraline | Participants will take sertraline for 12 weeks |
| FG001 | Placebo | Participants will take placebo for 12 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Sertraline | Participants will take sertraline for 12 weeks |
| BG001 | Placebo | Participants will take placebo for 12 weeks |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Symptoms of Depression in Congestive Heart Failure Patients With Clinical Depression After Treatment With Sertraline or Placebo | Symptoms of depression (as measured by the Hamilton Depression Rating Scale, HDRS) in congestive heart failure patients with clinical depression after treatment with sertraline or placebo. The 17-item Hamilton Depression Rating Scale (HDRS) is a rater-administered assessment of depression severity, with total score ranges from 0 (not at all depressed) to 52 (most severely depressed). Change in depression was measured as the difference between the 12-week HDRS scores and the baseline HDRS scores. Thus, a negative value reflects an improvement in depressive symptoms over the 12-week period. | Analysis was based on intent to treat (ITT), using random coefficient modeling. | Posted | Mar 2009 | Mean | Standard Deviation | HDRS Change Score | Measured at Week 12 |
|
12-weeks
All participants were followed via phone or mail to ascertain clinical events and vital status every 2 weeks during the 12-week treatment phase. The national death index was used to ascertain vital status of participants who could not be reached via phone or mail.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sertraline | Serious adverse events in Sertraline Arm |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiovascular | Cardiac disorders | Other | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Congestive Heart Failure | Cardiac disorders | Other | Non-systematic Assessment |
NFS may have limited our ability to detect effect of sertraline on depression scores. Dropout rate was higher than expected. A 12-week duration of therapy may have been insufficient to show potential effects of sertraline on clinical outcomes.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Ranga Krishnan | Duke University | 919-668-3647 | krish001@mc.duke.edu |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D003863 | Depression |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D020280 | Sertraline |
| ID | Term |
|---|---|
| D015057 | 1-Naphthylamine |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D009281 | Naphthalenes |
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| Placebo | Drug | Dosage ranging from 50 mg to 200 mg once a day |
|
|
| Measured at Week 12 |
| Xiong GL, Prybol K, Boyle SH, Hall R, Streilein RD, Steffens DC, Krishnan R, Rogers JG, O'Connor CM, Jiang W; SADHART-CHF Investigators. Inflammation Markers and Major Depressive Disorder in Patients With Chronic Heart Failure: Results From the Sertraline Against Depression and Heart Disease in Chronic Heart Failure Study. Psychosom Med. 2015 Sep;77(7):808-15. doi: 10.1097/PSY.0000000000000216. |
| 20101071 | Derived | Steffens DC, Wei Jiang, Krishnan KR, Karoly ED, Mitchell MW, O'Connor CM, Kaddurah-Daouk R. Metabolomic differences in heart failure patients with and without major depression. J Geriatr Psychiatry Neurol. 2010 Jun;23(2):138-46. doi: 10.1177/0891988709358592. Epub 2010 Jan 25. |
| 18760123 | Derived | Jiang W, O'Connor C, Silva SG, Kuchibhatla M, Cuffe MS, Callwood DD, Zakhary B, Henke E, Arias RM, Krishnan R; SADHART-CHF Investigators. Safety and efficacy of sertraline for depression in patients with CHF (SADHART-CHF): a randomized, double-blind, placebo-controlled trial of sertraline for major depression with congestive heart failure. Am Heart J. 2008 Sep;156(3):437-44. doi: 10.1016/j.ahj.2008.05.003. Epub 2008 Jul 7. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Participants will take sertraline for 12 weeks
| OG001 | Placebo | Participants will take placebo for 12 weeks |
|
|
|
| Secondary | Percentage of Cardiac Events and Morbidity / Mortality, Including Rehospitalization, in Congestive Heart Failure Patients With Depression After Treatment With Sertraline or Placebo. | Composite cardiovascular scores are calculated for each participant using recorded cardiac events, morbidity/mortality, rehospitalization, and discontinuation due to cardiovascular events. Composite score is compared for sertraline and placebo treatment groups. | Analysis was based on intent to treat (ITT). | Posted | Mar 2009 | Number | percentage of participants | Measured at Week 12 |
|
|
|
|
| 57 |
| 234 |
| 22 |
| 234 |
| EG001 | Placebo | Serious adverse events in Placebo Arm | 63 | 235 | 23 | 235 |
| Psychiatric | Psychiatric disorders | Other | Non-systematic Assessment |
|
| Noncardiovascular and nonpsychiatric | General disorders | Other | Non-systematic Assessment |
|
| Unstable Angina | Cardiac disorders | Other | Non-systematic Assessment |
|
| Other Cardiovascular | Cardiac disorders | Other | Non-systematic Assessment |
|
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| D011084 |
| Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011083 | Polycyclic Compounds |
| Cardiovascular Status Unchanged |
|