Antidepressant Medication Treatment for Depression in Individuals With Chronic Heart Failure (SADHART-CHF)

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT00078286
First received: February 20, 2004
Last updated: January 23, 2013
Last verified: January 2013
Results First Received: May 11, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Heart Failure, Congestive
Chronic Heart Failure
Depression
Interventions: Drug: Sertraline
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment began in November, 2003 and concluded in March, 2008. Subjects were recruited from cardiology inpatient units as well as outpatient cardiology clinics.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Sertraline Participants will take sertraline for 12 weeks
Placebo Participants will take placebo for 12 weeks

Participant Flow:   Overall Study
    Sertraline     Placebo  
STARTED     234     235  
COMPLETED     138     152  
NOT COMPLETED     96     83  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Sertraline Participants will take sertraline for 12 weeks
Placebo Participants will take placebo for 12 weeks
Total Total of all reporting groups

Baseline Measures
    Sertraline     Placebo     Total  
Number of Participants  
[units: participants]
  234     235     469  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     131     147     278  
>=65 years     103     88     191  
Age  
[units: years]
Mean ± Standard Deviation
  62.9  ± 10.5     61.4  ± 11.1     62.1  ± 10.8  
Gender  
[units: participants]
     
Female     101     89     190  
Male     133     146     279  



  Outcome Measures
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1.  Primary:   Symptoms of Depression in Congestive Heart Failure Patients With Clinical Depression After Treatment With Sertraline or Placebo   [ Time Frame: Measured at Week 12 ]

2.  Secondary:   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 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Ranga Krishnan
Organization: Duke University
phone: 919-668-3647
e-mail: krish001@mc.duke.edu


Publications of Results:
Publications automatically indexed to this study:

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00078286     History of Changes
Other Study ID Numbers: Pro00010340, R01MH063211, DATR A4-GPX
Study First Received: February 20, 2004
Results First Received: May 11, 2009
Last Updated: January 23, 2013
Health Authority: United States: Federal Government