scholarly journals Study protocol for the PURSUIT-HFpEF study: a Prospective, Multicenter, Observational Study of Patients with Heart Failure with Preserved Ejection Fraction

BMJ Open ◽  
2020 ◽  
Vol 10 (10) ◽  
pp. e038294
Author(s):  
Shinichiro Suna ◽  
Shungo Hikoso ◽  
Takahisa Yamada ◽  
Masaaki Uematsu ◽  
Yoshio Yasumura ◽  
...  

IntroductionNeither the pathophysiology nor an effective treatment for heart failure with preserved ejection fraction (HFpEF) has been elucidated to date. The purpose of this ongoing study is to elucidate the pathophysiology and prognostic factors for patients with HFpEF admitted to participating institutes. We also aim to obtain insights into the development of new diagnostic and treatment methods by analysing patient background factors, clinical data and follow-up information.Methods and analysisThis study is a prospective, multicentre, observational study of patients aged ≥20 years admitted due to acute decompensated heart failure with preserved left ventricular ejection fraction (≥50%) and elevated N-terminal-pro brain natriuretic peptide (NT-proBNP) (≥400 pg/mL). The study began in June 2016, with the participation of Osaka University Hospital and 31 affiliated facilities. We will collect data on history in detail, accompanying diseases, quality of life, frailty score, medication history, and laboratory and echocardiographic data. We will follow-up each patient for 5 years, and collect outcome data on mortality, cause of death, and the number and cause of hospitalisation. The target number of registered cases is 1500 cases in 5 years.Ethics and disseminationThe protocol was approved by the Institutional Review Board (IRB) of Osaka University Hospital on 24 February 2016 (ID: 15471), and by the IRBs of the all participating facilities. The findings will be disseminated through peer-reviewed publications and conference presentations.

2020 ◽  
Vol 9 (9) ◽  
pp. 2932
Author(s):  
Mauro Feola ◽  
Arianna Rossi ◽  
Marzia Testa ◽  
Cinzia Ferreri ◽  
Alberto Palazzuoli ◽  
...  

Background. The diuretic response has been shown to be a robust independent marker of cardiovascular outcomes in acute heart failure patients. The objectives of this clinical research are to analyze two different formulas (diuretic response (DR) or response to diuretic (R-to-D)) in predicting 6-month clinical outcomes. Methods: Consecutive patients discharged alive after an acute decompensated heart failure (ADHF) were enrolled. All patients underwent N-terminal-pro hormone BNP (NT-proBNP) and an echocardiogram together with DR and R-to-D calculation during diuretic administration. Death by any cause, cardiac transplantation and worsening heart failure (HF) requiring readmission to hospital were considered cardiovascular events. Results: 263 patients (62% male, age 78 years) were analyzed at 6-month follow-up. During the follow-up 58 (22.05%) events were scheduled. Patients who experienced CV-event had a worse renal function (p = 0.001), a higher NT-proBNP (p = 0.001), a lower left ventricular ejection fraction (p = 0.01), DR (p = 0.02) and R-to-D (p = 0.03). Spearman rho’s correlation coefficient showed a strong direct correlation between DR and R to D in all patients (r = 0.93; p < 0.001) and both in heart failure with reduced ejection fraction (HFrEF) (r = 0.94; p < 0.001) and HF preserved ejection fraction (HFpEF) (r = 0.91; p < 0.001). At multivariate analysis, a value of R-to-D <1.69 kg/40 mg, but only <0.67 kg/40 mg for DR were significantly related to poor 6-month outcome (p = 0.04 and p = 0.05, respectively). Receiver operating characteristic (ROC) curve analyses demonstrated that DR and R-to-D are equivalent in predicting prognosis (area under curve (AUC): 0.39 and 0.40, respectively). Only R-to-D was inversely related to in-hospital stay (r = −0.23; p = 0.01). Conclusion: Adding diuresis to DR seemed to provide a better risk assessment in alive HF patients discharged after an acute decompensation.


Circulation ◽  
2020 ◽  
Vol 142 (Suppl_3) ◽  
Author(s):  
Patrick Prudhomme ◽  
Brault Gabriel ◽  
Pusca Laurence ◽  
Coderre Roxanne ◽  
Tétrault-Langlois Marianne ◽  
...  

Introduction: Early physician follow-up after hospital discharge for acute decompensated heart failure (ADHF) is recommended by the AHA to prevent early hospital readmission. This recommendation has not been specifically evaluated for heart failure with preserved ejection fraction (HFpEF). Hypothesis: Earlier follow-up should lead to decrease in readmissions for ADHF in the HFpEF population even when adjusting for confounding factors. Methods: Consecutive ADHF hospitalisation that occurred inclusively between 2015 and 2018 were reviewed. Main inclusion criterion was left ventricular ejection fraction ≥45%. The major exclusion criteria were: severe valvulopathy, hypertrophic cardiomyopathy, acute coronary syndrome 3 months before hospitalisation, chronic kidney failure (eGFR <30 ml/min), severe chronic respiratory disease and death before discharge. Follow-up delay after discharge was dichotomized (early vs late/no follow up) by using the median delay. Main outcome was hospital readmission in the year following discharge. Multivariate logistic regression was performed for main outcome according to follow-up delay and adjusted for age, sex, medication at discharge and major comorbid conditions. Results: A total of 163 heart failure readmission (37% of patients) occurred in 438 patients in the year following the first hospitalisation. Median readmission delay was of 62 days. Median dedicated follow-up delay was 30 days and was arranged in 68% of cases. After adjusting for confounding variables, early follow-up was significantly associated with fewer readmission (adjusted odds ratio 0.57, 95% CI; 0.34-0.97). Conclusions: Early dedicated follow-up after discharge for HFpEF was associated with fewer readmission over the year following discharge even when adjusting for major confounding variables.


Circulation ◽  
2020 ◽  
Vol 142 (Suppl_3) ◽  
Author(s):  
Natasha Cuk ◽  
Jae H Cho ◽  
Donghee Han ◽  
Joseph E Ebinger ◽  
Eugenio Cingolani

Introduction: Sudden death due to ventricular arrhythmias (VA) is one of the main causes of mortality in patients with heart failure and preserved ejection fraction (HFpEF). Ventricular fibrosis in HFpEF has been suspected as a substrate of VA, but the degree of fibrosis has not been well characterized. Hypothesis: HFpEF patients with increased degree of fibrosis will manifest more VA. Methods: Cedars-Sinai medical records were probed using Deep 6 artificial intelligence data extraction software to identify patients with HFpEF who underwent cardiac magnetic resonance imaging (MRI). MRI of identified patients were reviewed to measure extra-cellular volume (ECV) and degree of fibrosis. Ambulatory ECG monitoring (Ziopatch) of those patients were also reviewed to study the prevalence of arrhythmias. Results: A total of 12 HFpEF patients who underwent cardiac MRI were identified. Patients were elderly (mean age 70.3 ± 7.1), predominantly female (83%), and overweight (mean BMI 32 ± 9). Comorbidities included hypertension (83%), dyslipidemia (75%), and coronary artery disease (67%). Mean left ventricular ejection fraction by echocardiogram was 63 ± 8.7%. QTc as measured on ECG was not significantly prolonged (432 ± 15 ms). ECV was normal in those patients for whom it was available (24.2 ± 3.1, n = 9) with 3/12 patients (25%) demonstrating ventricular fibrosis by MRI (average burden of 9.6 ± 5.9%). Ziopatch was obtained in 8/12 patients (including all 3 patients with fibrosis) and non-sustained ventricular tachycardia (NSVT) was identified in 5/8 (62.5%). One patient with NSVT and without fibrosis on MRI also had a sustained VA recorded. In those patients who had Ziopatch monitoring, there was no association between presence of fibrosis and NSVT (X2 = 0.035, p = 0.85). Conclusions: Ventricular fibrosis was present in 25% of HFpEF patients in this study and NSVT was observed in 62.5% of those patients with HFpEF who had Ziopatch monitoring. The presence of fibrosis by Cardiac MRI was not associated with NSVT in this study; however, the size of the cohort precludes broadly generalizable conclusions about this association. Further investigation is required to better understand the relationship between ventricular fibrosis by MRI and VA in patients with HFpEF.


2021 ◽  
Vol 10 (21) ◽  
pp. 4989
Author(s):  
Mohammad Abumayyaleh ◽  
Christina Pilsinger ◽  
Ibrahim El-Battrawy ◽  
Marvin Kummer ◽  
Jürgen Kuschyk ◽  
...  

Background: The angiotensin receptor-neprilysin inhibitor (ARNI) decreases cardiovascular mortality in patients with chronic heart failure with a reduced ejection fraction (HFrEF). Data regarding the impact of ARNI on the outcome in HFrEF patients according to heart failure etiology are limited. Methods and results: One hundred twenty-one consecutive patients with HFrEF from the years 2016 to 2017 were included at the Medical Centre Mannheim Heidelberg University and treated with ARNI according to the current guidelines. Left ventricular ejection fraction (LVEF) was numerically improved during the treatment with ARNI in both patient groups, that with ischemic cardiomyopathy (n = 61) (ICMP), and that with non-ischemic cardiomyopathy (n = 60) (NICMP); p = 0.25. Consistent with this data, the NT-proBNP decreased in both groups, more commonly in the NICMP patient group. In addition, the glomerular filtration rate (GFR) and creatinine changed before and after the treatment with ARNI in both groups. In a one-year follow-up, the rate of ventricular tachyarrhythmias (ventricular tachycardia and ventricular fibrillation) tended to be higher in the ICMP group compared with the NICMP group (ICMP 38.71% vs. NICMP 17.24%; p = 0.07). The rate of one-year all-cause mortality was similar in both groups (ICMP 6.5% vs. NICMP 6.6%; log-rank = 0.9947). Conclusions: This study shows that, although the treatment with ARNI improves the LVEF in ICMP and NICMP patients, the risk of ventricular tachyarrhythmias remains higher in ICMP patients in comparison with NICMP patients. Renal function is improved in the NICMP group after the treatment. Long-term mortality is similar over a one-year follow-up.


Author(s):  
Parisa Gholami ◽  
Shoutzu Lin ◽  
Paul Heidenreich

Background: BNP testing is now common though it is not clear if the test results are used to improve patient care. A high BNP may be an indicator that the left ventricular ejection fraction (LVEF) is low (<40%) such that the patient will benefit from life-prolonging therapy. Objective: To determine how often clinicians obtained a measure of LVEF (echocardiography, nuclear) following a high BNP value when the left ventricular ejection fraction (LVEF) was not known to be low (<40%). Methods and Results: We reviewed the medical records of 296 consecutive patients (inpatient or outpatient) with a BNP values of at least 200 pg/ml at a single medical center (tertiary hospital with 8 community clinics). A prior diagnosis of heart failure was made in 65%, while 42% had diabetes, 79% had hypertension, 59% had ischemic heart disease and 31% had chronic lung disease. The mean age was 73 ± 12 years, 75% were white, 10% black, 15% other and the mean BNP was 810 ± 814 pg/ml. The LVEF was known to be < 40% in 84 patients (28%, mean BNP value of 1094 ± 969 pg/ml). Of the remaining 212 patients without a known low LVEF, 161 (76%) had a prior LVEF >=40% ( mean BNP value of 673 ± 635 pg/ml), and 51 (24%) had no prior LVEF documented (mean BNP 775 ± 926 pg/ml). Following the high BNP, a measure of LVEF was obtained (including outside studies documented by the primary care provider) within 6 months in only 53% (113 of 212) of those with an LVEF not known to be low. Of those with a follow-up echocardiogram, the LVEF was <40% in 18/113 (16%) and >=40% in 95/113 (84%). There was no significant difference in mean initial BNP values between those with a follow-up LVEF <40% (872 ± 940pg/ml), >=40% (704 ± 737 pg/ml), or not done (661 ± 649 pg/ml, p=0.5). Conclusions: Follow-up measures of LVEF did not occur in almost 50% of patients with a high BNP where the information may have led to institution of life-prolonging therapy. Of those that did have a follow-up study a new diagnosis of depressesd LVEF was noted in 16%. Screening of existing BNP and LVEF data and may be an efficient strategy to identify patients that may benefit from life-prolonging therapy for heart failure.


Circulation ◽  
2020 ◽  
Vol 142 (Suppl_3) ◽  
Author(s):  
Tsutomu Kawai ◽  
Takahisa Yamada ◽  
Tetsuya Watanabe ◽  
Shunsuke Tamaki ◽  
Shungo Hikoso ◽  
...  

Backgrounds: Although B-type natriuretic peptide (BNP) and N-terminal pro B-type natriuretic peptide (NT-proBNP ) are interrelated parameters in assessment heart failure severity and prognosis, the ratio of NT-proBNP to BNP (NT-proBNP/BNP) are affected by various clinical factors, such as renal function. However, little is known about the influence of inflammation on NT-proBNP/BNP in patients with heart failure and preserved ejection fraction (HFpEF). Methods and Results: Patients data were extracted from PURSUIT-HFpEF registry, which is a multicenter prospective observational study including patients hospitalized for acute heart failure with left ventricular ejection fraction of >50%. Of 871 patients, data of BNP and NT-proBNP was available in 654 patients. The median baseline concentration of BNP was 474 pg/ml (299-720), NT-proBNP was 3310 pg/ml (1740-6840), and NT-proBNP/BNP was 7.6 (5.0-11.8). In multivariable linear regression analyses, older age [odds ratio (OR); 1.05, 95% confidence interval (CI); 1.02-1.09, p=0.001], higher creatinine [OR; 2.63, 95% CI; 1.66-4.16, p<0.001], and higher C-reactive protein (CRP) [OR; 1.17, 95% CI; 1.06-1.28, p<0.001] were significantly associated with a higher NT-proBNP/BNP (>median value of 7.6). However, other factors expected to affect NT-proBNP/BNP, such as atrial fibrillation and body mass index, were not associated with a higher NT-proBNP/BNP in this study. Patients in the highest CRP quartile had significantly higher NT-proBNP/BNP than those with other quartiles. Conclusion: In HFpEF patients, concomitant inflammation was associated with high NT-proBNP/BNP, which indicated that we need a careful interpretation on these two natriuretic peptides of patients with HFpEF and inflammatory status, such as infection.


Circulation ◽  
2020 ◽  
Vol 142 (Suppl_3) ◽  
Author(s):  
Takanari Kimura ◽  
Shungo Hikoso ◽  
Nakatani Daisaku ◽  
Shunsuke Tamaki ◽  
Masamichi Yano ◽  
...  

Background: Sarcopenia is associated with poor prognosis in chronic heart failure. Fat-free mass index (FFMI) is an indicator of resting energy expenditure and has been used for the clinical diagnosis of sarcopenia. However, the prognostic impact of sarcopenia diagnosed by FFMI remains to be elucidated in patients admitted with acute decompensated heart failure (ADHF) and preserved LVEF (HFpEF), relating to gender. Methods: Patients' data were extracted from The Prospective mUlticenteR obServational stUdy of patIenTs with Heart Failure with Preserved Ejection Fraction (PURSUIT-HFpEF) study, which is a prospective multicenter observational registry for ADHF patients with LVEF ≥50% in Osaka. We studied 621 patients who survived to discharge (men, n=281 and women, n=340). Fat-free mass (FFM) was estimated by the formula [FFM (kg) = 7.38 + 0.02908 х urinary creatinine (mg/day)] and normalized by the square of the patient’s height in meters to calculate FFMI at discharge. Sarcopenia was defined as FFMI <17 kg/m2 in men and <15 kg/m2 in women. The endpoint was all-cause death. Results: During a follow-up period of 1.5±0.8 yrs, 102 patients died (men, n=46 and women, n=56). At multivariate Cox analysis, FFMI was significantly associated with the mortality independently of age, estimated glomerular filtration rate, NT-proBNP and LVEF in both men (p=0.0155) and women (p=0.0223). Patients with sarcopenia had a significantly higher risk of all-cause death than those without sarcopenia in both genders (Figure). Conclusions: In this multicenter study, sarcopenia diagnosed by FFMI was shown to be associated with poor clinical outcome in HFpEF patients admitted with ADHF in both genders.


Cardiology ◽  
2020 ◽  
Vol 145 (5) ◽  
pp. 275-282 ◽  
Author(s):  
Pablo Díez-Villanueva ◽  
Lourdes Vicent ◽  
Francisco de la Cuerda ◽  
Alberto Esteban-Fernández ◽  
Manuel Gómez-Bueno ◽  
...  

Background: A significant number of heart failure (HF) patients with reduced left ventricular ejection fraction (LVEF) experience ventricular function recovery during follow-up. We studied the variables associated with LVEF recovery in patients treated with sacubitril/valsartan (SV) in clinical practice. Methods: We analyzed data from a prospective and multicenter registry including 249 HF outpatients with reduced LVEF who started SV between October 2016 and March 2017. The patients were classified into 2 groups according to LVEF at the end of follow-up (>35%: group R, or ≤35%: group NR). Results: After a mean follow-up of 7 ± 0.1 months, 62 patients (24.8%) had LVEF >35%. They were older (71.3 ± 10.8 vs. 67.5 ± 12.1 years, p = 0.025), and suffered more often from hypertension (83.9 vs. 73.8%, p = 0.096) and higher blood pressure before and after SV (both, p < 0.01). They took more often high doses of beta-blockers (30.6 vs. 27.8%, p = 0.002), with a smaller proportion undergoing cardiac resynchronization therapy (14.8 vs. 29.0%, p = 0.028) and fewer implanted cardioverter defibrillators (ICD; 32.8 vs. 67.9%, p < 0.001), this being the only predictive variable of NR in the multivariate analysis (OR 0.26, 95% CI 0.13–0.47, p < 0.0001). At the end of follow-up, the mean LVEF in group R was 41.9 ± 8.1% (vs. 26.3 ± 4.7% in group NR, p < 0.001), with an improvement compared with the initial LVEF of 14.6 ± 10.8% (vs. 0.8 ± 4.5% in group NR, p < 0.0001). Functional class improved in both groups, mainly in group R (p = 0.035), with fewer visits to the emergency department (11.5 vs. 21.6%, p = 0.07). Conclusions: In patients with LVEF ≤35% treated with SV, not carrying an ICD was independently associated with LVEF recovery, which was related to greater improvement in functional class.


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