Heart Failure, CongestivePhase 2/3SADHART-CHFNCT00078286
Antidepressant Medication Treatment for Depression in Individuals With Chronic Heart Failure
A Phase 2/3 study testing Sertraline in people with Heart Failure, Congestive and Chronic Heart Failure, run by Duke University at 1 site in United States.
Trial summary
This study will examine the effect of antidepressant medication on rates of death and disease in depressed people with chronic heart failure. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Heart Failure, Congestive, Chronic Heart Failure, Depression
- What is being tested?
- Sertraline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 469 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2003to Sep 2008
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic heart failure
- Diagnostic and Statistical Manual- Fourth Edition (DSM-IV) criteria for major depression
- Current use of any antipsychotic medication at study entry
Who cannot join
- Life-threatening comorbidity with a 50% or higher likelihood of death within 1 year
- History of psychoses, bipolar disorder, or severe personality disorder
- History of alcohol or drug dependence in the last year
- Severe physical disability that may interfere with the study
- Neurological impairment
- Active suicidal ideations
- Current use of antidepressant medication(s) at the start of study medication
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety and Efficacy of Sertraline for Depression CHF
This study will examine the effect of antidepressant medication on rates of death and disease in depressed people with chronic heart failure.
Read the detailed description
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.
- Conditions
- Heart Failure, Congestive, Chronic Heart Failure, Depression
- Being tested
- Sertraline, Placebo
- Keywords
- Antidepressive Agents
- Medical subject headings
- Heart Failure, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SertralineDrug
Also called Zoloft
Dosage ranging from 50 mg to 200 mg once a day
PlaceboDrug
Also called Inactive pill
Dosage ranging from 50 mg to 200 mg once a day
| Study group | Role | What they receive |
|---|---|---|
| Sertraline | Experimental | Participants will take sertraline for 12 weeks Receives: Drug: Sertraline |
| Placebo | Placebo comparator | Participants will take placebo for 12 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: Measured at Week 12
Secondary outcomes (1)
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.
Measured: Measured at Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2004 (estimated)
- Study startNov 2003
- Primary completionMar 2008
- Study completionSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Heart Failure, CongestiveStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe 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
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 469 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Ranga Krishnan, PhD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00078286
- Sponsor's protocol ID
- Pro00010340
- Other IDs
- R01MH063211, DATR A4-GPX
- Acronym
- SADHART-CHF
- Status last verified
- Jan 2013
- First submitted
- 20 Feb 2004
- Last updated
- 27 Feb 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 20723799Xiong 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.
PubMed 26186432Steffens 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.
PubMed 20101071Jiang 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.
PubMed 18760123
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Sertraline for Depression CHF
- ClinicalTrials.gov ID
- NCT00078286
- Acronym / sponsor ID
- SADHART-CHF / Pro00010340
- Conditions
- Heart Failure, Congestive, Chronic Heart Failure, Depression
- Keywords
- Antidepressive Agents
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 469 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Nov 2003
- Primary completion
- Mar 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 24 Feb 2004 (estimated)
- Results
- Posted 27 Feb 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will examine the effect of antidepressant medication on rates of death and disease in depressed people with chronic heart failure.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sertraline | Experimental | Drug: SertralineParticipants will take sertraline for 12 weeks |
| Placebo | Placebo comparator | Drug: PlaceboParticipants will take placebo for 12 weeks |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Chronic heart failure
- Diagnostic and Statistical Manual- Fourth Edition (DSM-IV) criteria for major depression
- Current use of any antipsychotic medication at study entry
Key exclusion criteria (7 listed)
- Life-threatening comorbidity with a 50% or higher likelihood of death within 1 year
- History of psychoses, bipolar disorder, or severe personality disorder
- History of alcohol or drug dependence in the last year
- Severe physical disability that may interfere with the study
- Neurological impairment
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 |
|---|---|---|
| SertralineAlso: ZoloftDosage ranging from 50 mg to 200 mg once a day | Drug | Sertraline |
| PlaceboAlso: Inactive pillDosage ranging from 50 mg to 200 mg once a day | Drug | Placebo |
Primary outcome
Symptoms of Depression in Congestive Heart Failure Patients With Clinical Depression After Treatment With Sertraline or Placebo
Time frame: Measured at Week 12
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.
1 secondary outcome
Percentage of Cardiac Events and Morbidity / Mortality, Including Rehospitalization, in Congestive Heart Failure Patients With Depression After Treatment With Sertraline or Placebo.
Time frame: Measured at Week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 20723799O'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.
- Derived from this study: PubMed 26186432Xiong 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.
- Derived from this study: PubMed 20101071Steffens 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.
- Derived from this study: PubMed 18760123Jiang 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.
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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.
Ranga Krishnan, PhD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Sertraline in people with Heart Failure, Congestive and Chronic Heart Failure, run by Duke University 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 7 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 27 Feb 2013. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Feb 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Symptoms of Depression in Congestive Heart Failure Patients With Clinical Depression After Treatment With Sertraline or Placebo (time frame: Measured at Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00078286, which also lists 4 linked publications.
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 27 Feb 2013.