Long-Chain Omega-3 Fatty Acid Supplements in Depressed Heart Failure Patients: Results of the OCEAN Trial.

OBJECTIVES: The goal of this study was to test the effects of long-chain omega-3 fatty acid supplementation on omega-3 levels, depressive symptoms, and other psychosocial factors, as well as other chronic heart failure (CHF)-related functional measures. BACKGROUND: Patients with CHF and depression had low blood omega-3 concentrations that were associated with an elevated risk of mortality. METHODS: This study was a randomized, double-blind, placebo-controlled pilot clinical trial using a 400/200 eicosapentaenoic acid (EPA)/docosahexaenoic acid (DHA) fish oil at 2 g and an almost pure EPA at 2 g, compared with a matched placebo, daily for 12 weeks for patients with CHF and major depressive disorder. Statistical analyses included the intention-to-treat population and "completers" (defined as participants consuming ≥70% of the capsules and completing the final endpoint evaluation between 10 and 14 weeks). RESULTS: A total of 108 patients with CHF and major depressive disorder and a score ≥18 on the Hamilton Depression Scale who were randomized at 1:1:1 to the 3 interventions at 3 enrolling centers from June 12, 2014, to May 19, 2016; 80 (74.1%) qualified as completers. Intention-to-treat analyses revealed that the levels of all omega-3 variables were significantly elevated in the omega-3 groups, whereas the placebo group showed little change; there were no between-group differences with overall depression measurements. Per-protocol exploratory analyses showed that scores on the social functioning measurement of the 36-item Short Form Health Survey improved notably in the 400/200 EPA/DHA (p = 0.040) and EPA (p = 0.10) groups compared with the placebo group. Spearman correlation analysis indicated that increased omega-3 indices were associated with improved cognitive depressive symptoms. CONCLUSIONS: Omega-3 supplementation resulted in significant increases in omega-3 levels in red blood cell counts, corresponding to a particular compound of omega-3. Changes in cognitive depressive symptoms and social function were in favor of the omega-3 supplementation. Further studies with larger sample sizes are necessary to confirm the benefits of omega-3 supplementation on modifying psychosocial factors for patients with CHF. (Omega-3 Supplementation for Co-Morbid Depression and Heart Failure Treatment [OCEAN]; NCT02057406).

Efficacy and Safety of Spironolactone in Acute Heart Failure: The ATHENA-HF Randomized Clinical Trial.

Importance: Persistent congestion is associated with worse outcomes in acute heart failure (AHF). Mineralocorticoid receptor antagonists administered at high doses may relieve congestion, overcome diuretic resistance, and mitigate the effects of adverse neurohormonal activation in AHF. Objective: To assess the effect of high-dose spironolactone and usual care on N-terminal pro-B-type natriuretic peptide (NT-proBNP) levels compared with usual care alone. Design, Setting, and Participants: This double-blind and placebo (or low-dose)-controlled randomized clinical trial was conducted in 22 US acute care hospitals among patients with AHF who were previously receiving no or low-dose (12.5 mg or 25 mg daily) spironolactone and had NT-proBNP levels of 1000 pg/mL or more or B-type natriuretic peptide levels of 250 pg/mL or more, regardless of ejection fraction. Interventions: High-dose spironolactone (100 mg) vs placebo or 25 mg spironolactone (usual care) daily for 96 hours. Main Outcomes and Measures: The primary end point was the change in NT-proBNP levels from baseline to 96 hours. Secondary end points included the clinical congestion score, dyspnea assessment, net urine output, and net weight change. Safety end points included hyperkalemia and changes in renal function. Results: A total of 360 patients were randomized, of whom the median age was 65 years, 129 (36%) were women, 200 (55.5%) were white, 151 (42%) were black, 8 (2%) were Hispanic or Latino, 9 (2.5%) were of other race/ethnicity, and the median left ventricular ejection fraction was 34%. Baseline median (interquartile range) NT-proBNP levels were 4601 (2697-9596) pg/mL among the group treated with high-dose spironolactone and 3753 (1968-7633) pg/mL among the group who received usual care. There was no significant difference in the log NT-proBNP reduction between the 2 groups (-0.55 [95% CI, -0.92 to -0.18] with high-dose spironolactone and -0.49 [95% CI, -0.98 to -0.14] with usual care, P = .57). None of the secondary end point or day-30 all-cause mortality or heart failure hospitalization rate differed between the 2 groups. The changes in serum potassium and estimated glomerular filtration rate at 24, 48, 72, and 96 hours. were similar between the 2 groups. Conclusions and Relevance: Adding treatment with high-dose spironolactone to usual care for patients with AHF for 96 hours was well tolerated but did not improve the primary or secondary efficacy end points. Trial Registration: clinicaltrials.gov Identifier: NCT02235077.

Prevalence of hypovitaminosis D in cardiovascular diseases (from the National Health and Nutrition Examination Survey 2001 to 2004).

This cross-sectional study examined the burden of cardiovascular diseases (CVDs) using serum 25-hydroxyvitamin D (25[OH]D) and prevalence of hypovitaminosis D in adults with CVDs using data from NHANES 2001 to 2004. Serum 25(OH)D levels were divided into 3 categories (> or =30, 20 to 29, and <20 ng/ml), and hypovitaminosis D was defined as vitamin D <30 ng/ml. Of 8,351 adults who had 25(OH)D measured, mean 25(OH)D was 24.3 ng/ml, and the prevalence of hypovitaminosis D was 74%. The burden of CVDs increased with lower 25(OH)D categories, with 5.3%, 6.7%, and 7.3% coronary heart disease; 1.5%, 2.4%, and 3.2% heart failure; 2.5%, 2.0%, and 3.2% stroke; and 3.6%, 5.0%, and 7.7% peripheral arterial disease. Across all CVDs, hypovitaminosis D was more common in blacks than Hispanics or whites. Compared with persons at low risk for CVDs (68%), it was more prevalent in those at high risk (75%; odds ratio [OR] 1.32, 95% confidence interval [CI] 1.05 to 1.67), with coronary heart disease (77%; OR 1.48, 95% CI 1.14 to 1.91), and both coronary heart disease and heart failure (89%; OR 3.52, 95% CI 1.58 to 7.84) after controlling for age, race, and gender. In conclusion, hypovitaminosis D was highly prevalent in US adults with CVDs, particularly those with both coronary heart disease and heart failure.

Financial implications of a model heart failure disease management program for providers, hospital, healthcare systems, and payer perspectives.

Although heart failure disease management (HFDM) programs improve patient outcomes, the implementation of these programs has been limited because of financial barriers. We undertook the present study to understand the economic incentives and disincentives for adoption of disease management strategies from the perspectives of a physician (group), a hospital, an integrated health system, and a third-party payer. Using the combined results of a group of randomized controlled trials and a set of financial assumptions from a single academic medical center, a financial model was developed to compute the expected costs before and after the implementation of a HFDM program by 3 provider types (physicians, hospitals, and health systems), as well as the costs incurred from a payer perspective. The base-case model showed that implementation of HFDM results in a net financial loss to all potential providers of HFDM. Implementation of HFDM as described in our base-case analysis would create a net loss of US dollars 179,549 in the first year for a physician practice, US dollars 464,132 for an integrated health system, and US dollars 652,643 in the first year for a hospital. Third-party payers would be able to save US dollars 713,661 annually for the care of 350 patients with heart failure in a HFDM program. In conclusion, although HFDM programs may provide patients with improved clinical outcomes and decreased hospitalizations that save third-party payers money, limited financial incentives are currently in place for healthcare providers and hospitals to initiate these programs.