Dataset Information

Representativeness of a Heart Failure Trial by Race and Sex: Results From ASCEND-HF and GWTG-HF.

ABSTRACT: OBJECTIVES:This study sought to determine the degree to which U.S. patients enrolled in a heart failure (HF) trial represent patients in routine U.S. clinical practice according to race and sex. BACKGROUND:Black patients and women are frequently under-represented in HF clinical trials. However, the degree to which black patients and women enrolled in trials represent such patients in routine practice is unclear. METHODS:The ASCEND-HF (Acute Study of Clinical Effectiveness of Nesiritide in Decompensated Heart Failure) trial randomized patients hospitalized for HF to receive nesiritide or placebo from May 2007 to August 2010 and was neutral for clinical endpoints. This analysis compared non-Hispanic white (n = 1,494) and black (n = 1,012) patients enrolled in ASCEND-HF from the U.S. versus non-Hispanic white and black patients included in a U.S. hospitalized HF registry (i.e., Get With The Guidelines-Heart Failure [GWTG-HF]) during the ASCEND-HF enrollment period and meeting trial eligibility criteria. RESULTS:Among 79,291 white and black registry patients, 49,063 (62%) met trial eligibility criteria (white, n = 37,883 [77.2%]; black, n = 11,180 [22.8%]). Women represented 35% and 49% of the ASCEND-HF and trial-eligible GWTG-HF cohorts, respectively. Compared with trial-enrolled patients, trial-eligible GWTG-HF patients tended to be older with higher blood pressure and higher ejection fraction. Trial-eligible patients had higher in-hospital mortality (2.3% vs. 1.3%), 30-day readmission (20.2% vs. 16.8%), and 180-day mortality (21.2% vs. 18.6%) than those enrolled in the trial (all p < 0.02), with consistent mortality findings by race and sex. After propensity score matching, mortality rates were similar; however, trial-eligible patients continued to have higher rates of 30-day readmission (23.1% vs. 17.3%; p < 0.01), driven by differences among black patients and women (all p for interaction ?0.02). CONCLUSIONS:Patients with HF seen in U.S. practice and eligible for the ASCEND-HF trial had worse clinical outcomes than those enrolled in the trial. After accounting for clinical characteristics, trial-eligible real-world patients continued to have higher rates of 30-day readmission, driven by differences among black patients and women. Social, behavioral, and other unmeasured factors may impair representativeness of patients enrolled in HF trials, particularly among racial/ethnic minorities and women. (Acute Study of Clinical Effectiveness of Nesiritide in Decompensated Heart Failure [ASCEND-HF]; NCT00475852).

SUBMITTER: Greene SJ

PROVIDER: S-EPMC7362664 | biostudies-literature | 2019 Nov

REPOSITORIES: biostudies-literature

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Representativeness of a Heart Failure Trial by Race and Sex: Results From ASCEND-HF and GWTG-HF.

Greene Stephen J SJ DeVore Adam D AD Sheng Shubin S Fonarow Gregg C GC Butler Javed J Califf Robert M RM Hernandez Adrian F AF Matsouaka Roland A RA Samman Tahhan Ayman A Thomas Kevin L KL Vaduganathan Muthiah M Yancy Clyde W CW Peterson Eric D ED O'Connor Christopher M CM Mentz Robert J RJ

JACC. Heart failure 20191009 11

<h4>Objectives</h4>This study sought to determine the degree to which U.S. patients enrolled in a heart failure (HF) trial represent patients in routine U.S. clinical practice according to race and sex.<h4>Background</h4>Black patients and women are frequently under-represented in HF clinical trials. However, the degree to which black patients and women enrolled in trials represent such patients in routine practice is unclear.<h4>Methods</h4>The ASCEND-HF (Acute Study of Clinical Effectiveness o ...[more]

PMID: 31606362

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Project description:OBJECTIVES:This study sought to evaluate the influence of race/ethnicity on the relationship between body mass index (BMI) and mortality in heart failure with preserved ejection fraction (HFpEF) and HF with reduced EF (HFrEF) patients. BACKGROUND:Prior studies demonstrated an "obesity paradox" among overweight and obese patients, where they have a better HF prognosis than normal weight patients. Less is known about the relationship between BMI and mortality among diverse patients with HF, particularly given disparities in obesity and HF prevalence. METHODS:The authors used Get With The Guidelines-Heart Failure data to assess the relationship between BMI and in-hospital mortality by using logistic regression modeling. The authors assessed 30-day and 1-year rates of all-cause mortality following discharge by using Cox regression modeling. RESULTS:A total of 39,647 patients with HF were included (32,434 [81.8%] white subjects; 3,809 [9.6%] black subjects; 1,928 [4.9%] Hispanic subjects; 544 [1.4%] Asian subjects; and 932 [2.3%] other subjects); 59.7% of subjects had HFpEF, and 30.7% were obese. More black and Hispanic patients had Class I or higher obesity (BMI ?30 kg/m2) than whites, Asians, or other racial/ethnic groups (p < 0.0001). Among subjects with HFpEF, higher BMI was associated with lower 30-day mortality, up to 30 kg/m2 with a small risk increase above 30 kg/m2 (BMI: 30 vs. 18.5 kg/m2), hazard ratio (HR) of 0.63 (95% confidence interval [CI]: 0.54 to 0.73). A modest relationship was observed in HFrEF subjects (BMI: 30 vs. 18.5 kg/m2; HR: 0.73; 95% CI: 0.60 to 0.89), with no risk increase above 30 kg/m2. There were no significant interactions between BMI and race or ethnicity related to 30-day mortality (p > 0.05). CONCLUSIONS:This work is one of the first suggesting the obesity paradox for 30-day mortality exists at all BMI levels in HFrEF but not in patients with HFpEF. Higher BMI was associated with lower 30-day mortality across racial/ethnic groups in a manner inconsistent with the J-shaped relationship noted for coronary artery disease. The differential slope of obesity and mortality among HFpEF and patients with HFrEF potentially suggests differing mechanistic factors, requiring further exploration.

Project description:Background Randomized clinical trials in populations with heart failure with reduced ejection fraction may not be reflective of the general population with heart failure with reduced ejection fraction. Our study assessed the representativeness of the GALACTIC-HF (Global Approach to Lowering Adverse Cardiac Outcomes Through Improving Contractility in Heart Failure) patient population in Kaiser Permanente Southern California. Methods and Results We identified 9770 patients with a diagnosis of heart failure with reduced ejection fraction from 2014 to 2018 using electronic health records. Four mutually exclusive cohorts were created, including GALACTIC-HF-ineligible cohorts: (1) not taking guideline-directed medical therapy (GDMT) and (2) taking GDMT; and GALACTIC-HF-eligible cohorts with: (3) ejection fraction (EF) ≤28% and (4) EF 29% to 35%. Patients were followed for 30-day and 1-year mortality and 30-day, 180-day, and 1-year hospitalization. Overall, 3626 (37.1%) met GALACTIC-HF inclusion criteria with EF ≤35%, and 2367 (65.3%) of those individuals had EF ≤28%. The risk of 1-year mortality was lower among all cohorts versus the GALACTIC-HF-ineligible cohort not taking GDMT (hazard ratio, 0.80 [95% CI, 0.70-0.91], 0.84 [95% CI, 0.72-0.98], and 0.62 [95% CI, 0.51-0.75] for the GALACTIC-HF-ineligible cohort taking GDMT and GALACTIC-HF-eligible cohorts with EF ≤28% and 29%-35%, respectively). Compared with the GALACTIC-HF-ineligible cohort not taking GDMT, the short-term hospitalization risk at 30 and 180 days were similar for both GALACTIC-HF-eligible cohorts and the hospitalization risk at 1 year was similar for the GALACTIC-HF-eligible cohort with EF ≤28%. Conclusions A large portion of patients with heart failure with reduced ejection fraction with low EF met inclusion criteria for the GALACTIC-HF trial and, despite being on GDMT, had hospitalization rates similar to those not taking GDMT, suggesting potential benefits from other innovative treatments.

Project description:OBJECTIVES:As the largest acute heart failure (AHF) trial conducted to date, the global ASCEND-HF (Acute Study of Clinical Effectiveness of Nesiritide in Decompensated Heart Failure) trial database presented an opportunity to systematically describe the relationship among time of hospital presentation, clinical profile, inpatient management, and outcomes among patients admitted with AHF. BACKGROUND:Time of hospital presentation has been shown to impact outcomes among patients hospitalized with many conditions. However, the association among time of presentation and patient characteristics, management, and clinical outcomes among patients hospitalized with AHF has not been well characterized. METHODS:A post hoc analysis of the ASCEND-HF trial was performed, which enrolled 7,141 patients hospitalized for AHF. Patients were divided based on when they presented to the hospital; regular hours were defined as 9 am to 5 pm, Monday through Friday, and off hours were defined as 5 pm to 9 am, Monday through Friday and weekends. Clinical characteristics and outcomes were compared by time of presentation. RESULTS:Overall, 3,298 patients (46%) presented during off hours. Off-hour patients were more likely to have orthopnea (80% vs. 74%, respectively) and rales (56% vs. 49%, respectively) than regular-hour patients. Off-hour patients were more likely to receive intravenous (IV) nitroglycerin (18% vs. 11%, respectively) and IV loop diuretics (92% vs. 86%, respectively) as initial therapy and reported greater relief from dyspnea at 24 h (odds ratio [OR]: 1.14; 95% confidence interval [CI]: 1.04 to 1.24; p = 0.01) than regular-hour patients. After adjustment, off-hour presentation was associated with significantly lower 30-day mortality (OR: 0.74; 95% CI: 0.57 to 0.96; p = 0.03) and 180-day mortality (hazard ratio [HR]: 0.82; 95% CI: 0.72 to 0.94; p = 0.01) but similar 30-day rehospitalization rates (p = 0.40). CONCLUSIONS:In this AHF trial, patients admitted during off hours exhibited a distinct clinical profile, experienced greater dyspnea relief, and had lower post-discharge mortality than regular-hour patients. These findings have implications for future AHF trials.

Project description:Outcomes associated with episodes of hypotension while hospitalized with acute decompensated heart failure are not well understood.Using data from Acute Study of Clinical Effectiveness of Nesiritide in Decompensated Heart Failure (ASCEND-HF), we assessed factors associated with in-hospital hypotension and subsequent 30-day outcomes. Patients were classified as having symptomatic or asymptomatic hypotension. Multivariable logistic regression was used to determine factors associated with in-hospital hypotension, and Cox proportional hazards models were used to assess the association between hypotension and 30-day outcomes. We also tested for treatment interaction with nesiritide on 30-day outcomes and the association between in-hospital hypotension and renal function at hospital discharge. Overall, 1555 of 7141 (21.8%) patients had an episode of hypotension, of which 73.1% were asymptomatic and 26.9% were symptomatic. Factors strongly associated with in-hospital hypotension included randomization to nesiritide (odds ratio, 1.98; 95% confidence interval [CI], 1.76-2.23; P<0.001), chronic metolazone therapy (odds ratio, 1.74; 95% CI, 1.17-2.60; P<0.001), and baseline orthopnea (odds ratio, 1.31; 95% CI, 1.13-1.52; P=0.001) or S3 gallop (odds ratio, 1.21; 95% CI, 1.06-1.40; P=0.006). In-hospital hypotension was associated with increased hazard of 30-day mortality (hazard ratio, 2.03; 95% CI, 1.57-2.61; P<0.001), 30-day heart failure hospitalization or mortality (hazard ratio, 1.58; 95% CI, 1.34-1.86; P<0.001), and 30-day all-cause hospitalization or mortality (hazard ratio, 1.40; 95% CI, 1.22-1.61; P<0.001). Nesiritide had no interaction on the relationship between hypotension and 30-day outcomes (interaction P=0.874 for death, P=0.908 for death/heart failure hospitalization, P=0.238 death/all-cause hospitalization).Hypotension while hospitalized for acute decompensated heart failure is an independent risk factor for adverse 30-day outcomes, and its occurrence highlights the need for modified treatment strategies.http://www.clinicaltrials.gov. Unique identifier: NCT00475852.

Dataset Information

Representativeness of a Heart Failure Trial by Race and Sex: Results From ASCEND-HF and GWTG-HF.

Publications

Representativeness of a Heart Failure Trial by Race and Sex: Results From ASCEND-HF and GWTG-HF.

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