The SADHART-CHF Study

However, there was an additional study that followed up on the SADHART trial 8 years later called the SADHART-CHF trial. The SADHART-CHF trial was a “randomized, double blind placebo controlled trial of sertraline 50 to 200 mg/ day versus placebo for 12 weeks” (O’Connor et al., 2010). Patients who were eligible for the study had to be 45 years or older with heart failure and diagnosed with depression according to the DSM IV edition. The sample size of the study was 469 patients and 234 of the patients were randomized to the sertraline trial. In the analysis of the SADHART-CHF, it was demonstrated that during a 12-week intervention with selective serotonin reuptake inhibitors, more specifically sertraline, “had comparable effects on depression
and cardiovascular outcomes as the placebo group” (Jiang et al., 2011). Other important findings from the study were that all participants’ depression scores improved over the course of the 12-week intervention from baseline (O’Connor et al., 2010).
One reason similar effects could have been detected was due to the fact that rather than the sertraline drug itself other factors such as close cardiovascular follow up along with nursing staff interactions could have led to improved mood disorders (O’Connor et al., 2010). In addition, the SADHART-CHF trial further confirmed that patients with depression and heart failure are at a high risk of mortality. According to the study, at the 12-week mark, a “mortality rate of 7% was confirmed” (O’Connor et al., 2010). Some of the limitations of the study was that nursing support in the placebo group may have lead to the improvement of scores in the placebo group, therefore narrowing the difference between the sertraline intervention and placebo group. According to the authors of the SADHART-CHF trial, it is possible that greater support networks through nursing facilitating support may have had an effect on reducing the adverse outcomes associated with negative life stressors, which often leads to a decrease in cognitive function (Jiang et al.,
2011). Finally, the short duration of therapy may have lead to not enough time to detect the effects sertraline on cardiovascular outcomes (O’Connor et al., 2010).
It was ascertained that patients who remitted from depression experienced significantly fewer cardiac events, therefore showing the association that depression does have an impact on cardiovascular outcomes (Jiang et al., 2011). Interestingly, there seems to exist a correlation between gender and depression remission in the study. Men with heart failure “had a 2.5-fold chance for depression remission in comparison to the rest of the study population” (Jiang et al., 2011). It is also found that patients with greater “somatic symptoms” were found to be less likely to be in remission for depression (Jiang et al., 2011).
Mechanisms that Underlie how SSRIs impact Cardiovascular Outcomes
There are certain mechanisms in which SSRIs may impact cardiovascular outcomes.
SSRIs have shown “to increase heart rate variability and decrease cortisol concentrations” (Ruden et al., 2008). Even in non depressed individuals with coronary heart disease, “SSRIs have reported to decrease sympathetic nervous system activity at rest” (Ruden et al., 2008). Similar studies suggest a small improvement in cardiovascular symptoms for patients with comorbid condition of heart disease and depression. For example, a study conducted by Pizzi, found that when considering all observational studies, “SSRI use was associated with a significant decrease in CHD readmission and all cause mortality rates” (Pizzi et al., 2010). Interestingly enough, there are some studies that suggest the opposite that SSRIs could lead to serious cardiac events such as hospitalizations. In a study done by Glen Xiong et al., it was found that the use of SSRIs could, in fact, lead to higher rates of mortality and rehospitilization for patients who were receiving coronary artery bypass grafting, which is a surgical procedure that moves tissue from one site of the body to another (Xiong et al., 1999). In this study, patients were obtained using the Duke Database for Cardiovascular Disease to find patients who received coronary artery bypass grafting surgery from January 1, 1999 to December 31, 2003. As noted by the study, patients who received valvular surgery were excluded from the study, obtaining a sample of
4,794 patients (Xiong et al., 1999). The study furthermore had two groups, one being the experimental group and the other being the control group. The experimental group was patients who had exposure to SSRIs prior to their hospitalization and the control group was patients who did not have exposure to SSRIs. Patients were contacted six months after the procedure through self administered questionnaires and then annually to collect data of whether patients experienced adverse cardiac symptoms or were readmitted into the hospital. In addition to surveys, hospital records were obtained to confirm readmission data. While at first glance, it is interesting to note that SSRIs could be associated with adverse outcomes, it is important to not declare causality from this correlation. It is possible that the adverse health outcomes could be due to the varying forms of depression, rather than the SSRIs themselves. It is also plausibly that there is some other complex mechanism that has not been studied yet that could have resulted in these results. Another limitation of the study was that it was an observational study and the nature of the study makes it hard to draw any causal correlations between SSRIs and outcomes. Based on the methodology, there were some flaws in obtaining the patients to begin with. There was little screening of patients with depression at the outset of the study and therefore, patients who have untreated depression or on other antidepressants were not a part of the SSRI group (Xiong et al., 1999). This would have actually led to more adverse outcomes in patients in the non SSRI group because that would be a whole subset of patients who experienced depressive symptoms prior to the procedure. In addition, it is important to note that patients in the SSRI group could have had more serious forms of depression to begin with. As a result, the methodology suggests that the representativeness of the sample of participants could have been a limitation of the study.