scholarly journals Clinical characteristics and medical therapy in randomized clinical trial eligible-and-enrolled vs. eligible-but-not enrolled patients with ischaemic heart failure

2021 ◽  
Vol 42 (Supplement_1) ◽  
Author(s):  
L Czyz ◽  
J Chmiel ◽  
A Mazurek ◽  
L Drabik ◽  
E Kwiecien ◽  
...  

Abstract Introduction Clinical trial applicability to routine clinical practice is a fundamental consideration. Little is known about eligibility and enrolment in ischaemic heart failure (iHF) trials. Aim To compare clinical characteristics and medical therapy between subjects eligible-and-enrolled vs eligible-but-not-enrolled in iHF interventional randomized controlled trials (RCT). Material and methods Using our detailed database of consecutive hospitalizations, iHF patients clinical characteristics and medical treatment were compared for 4 following periods: P1 (6 months of RCT#1 recruitment), P2 (6 months after the RCT#1), P3 (6 months of RCT#2 recruitment), P4 (6 months after RCT#2). RCT#1 and RCT#2 had similar criteria that involved 18–80 years old, NYHA Class II-IV inclusion and LVEF ≤40% (inclusion), and tumor/neoplasm history, recent (≤3 months) or planned major surgery, heart transplant waiting list (exclusion). Eligibility and enrolment, and reasons for non-eligibility and non-enrolment, were evaluated along baseline clinical characteristics and medical treatment. Results Data of 5,436 patients were reviewed. Eligibility rate was similar between the periods evaluated (P1–56.45%, P2–43.14%, P3–58.49%, P4–50.25%). One in 2 (50.62%) ineligible patients had a single-only reason for ineligibility (recent [≤3 months] or recommended cardiac surgery/cardiovascular intervention outside the trial 16.3%, age>80 years 14.6%, Fig. 1 and Fig. 2). 13.2% of eligible patients were not enrolled due to lack of consent. Eligible-and-enrolled patients did not differ in baseline clinical characteristics such as sex, age, diabetes, and the clinical stage of heart failure against the eligible-but-not-enrolled patients. However, the eligible-and-enrolled had lower left ventricle ejection fraction (echocardiography; 31.2% vs. 33.9%, p=0.0393) and higher end-diastolic volume (197.8ml vs 160.4ml, p<0.0001). There were no differences in ACE/ARB inhibitor, B-blocker, diuretic (thiazide, loop, K+ sparing), sacubitril/valsartan and statin therapy between the groups. Eligible patients characteristics were not different between the recruitment (P1, P3) and non-recruitment periods (P2, P4). Conclusion Enrolment rate was high. Ineligibility resulted mainly from recent or recommended cardiovascular intervention outside RCT. Medical treatment was similar between eligible-and-enrolled and eligible-but-not-enrolled patients. Age (when within the inclusion criteria), gender and time frame were not factors of bias. However, the trial-enrolled patients had more severe left ventricle impairment. This argues, for iHF RCTs, against the routinely assumed lower-risk patient enrolment bias as signalled in other trial types and populations. FUNDunding Acknowledgement Type of funding sources: Public hospital(s). Main funding source(s): John Paul II Hospital, Krakow, Poland Figure 1 Figure 2

2014 ◽  
Vol 5 (1) ◽  
pp. 40-47 ◽  
Author(s):  
Wen Zhang ◽  
Dan Wen ◽  
Yan-Fang Zou ◽  
Ping-Yan Shen ◽  
Yao-Wen Xu ◽  
...  

Objective: To describe and analyze the clinical characteristics of acute kidney injury (AKI) patients with preexisting chronic heart failure (CHF) and to identify the prognostic factors of the 1-year outcome. Methods: A total of 120 patients with preexisting CHF who developed AKI between January 2005 and December 2010 were enrolled. CHF was diagnosed according to the European Society of Cardiology guidelines, and AKI was diagnosed using the RIFLE criteria. Clinical characteristics were recorded, and nonrecovery from kidney dysfunction as well as mortality were analyzed. Results: The median age of the patients was 70 years, and 58.33% were male. 60% of the patients had an advanced AKI stage (‘failure') and 90% were classified as NYHA class III/IV. The 1-year mortality rate was 35%. 25.83% of the patients progressed to end-stage renal disease after 1 year. Hypertension, anemia, coronary atherosclerotic heart disease and chronic kidney disease were common comorbidities. Multiple organ dysfunction syndrome (MODS; OR, 35.950; 95% CI, 4.972-259.952), arrhythmia (OR, 13.461; 95% CI, 2.379-76.161), anemia (OR, 6.176; 95% CI, 1.172-32.544) and RIFLE category (OR, 5.353; 95% CI, 1.436-19.952) were identified as risk factors of 1-year mortality. For 1-year nonrecovery from kidney dysfunction, MODS (OR, 8.884; 95% CI, 2.535-31.135) and acute heart failure (OR, 3.281; 95% CI, 1.026-10.491) were independent risk factors. Conclusion: AKI patients with preexisting CHF were mainly elderly patients who had an advanced AKI stage and NYHA classification. Their 1-year mortality and nonrecovery from kidney dysfunction rates were high. Identifying risk factors may help to improve their outcome.


2021 ◽  
Vol 11 (4) ◽  
pp. 933-941
Author(s):  
Jędrzej Piotrowski ◽  
Małgorzata Timler ◽  
Remigiusz Kozłowski ◽  
Arkadiusz Stasiak ◽  
Joanna Stasiak ◽  
...  

(1) Our study aimed to look at the clinical characteristics, treatment and short-term outcomes of patients hospitalized due to heart failure with coexisting cancer. (2) Methods: Seventy one cancer (Ca) patients and a randomly selected 70 patients without Ca, hospitalized due to heart failure exacerbation in the same time period constituted the study group (Ca patient group) and controls (non-Ca group), respectively. Data on clinical characteristics were collected retrospectively for both groups. (3) Results: Cancer patients presented with a less advanced NYHA class, had more frequent HFpEF, a higher peak troponin T level, and smaller left atrium size, as compared with controls. The in-hospital deaths of Ca patients were associated with: a higher New York Heart Association (NYHA) class, lower HgB level, worse renal function, higher K and AST levels, presence of diabetes mellitus, and HFpEF. By multivariate logistic regression analysis, impaired renal function was the only independent predictor of in-hospital death in Ca patients (OR-1.15; CI 1.05; 1.27); p = 0.017). The following covariates entered the regression: NYHA class, HgB, GFR, K+, AST, diabetes mellitus t.2, and HFpEF. (4) Conclusions: The clinical picture and the course of heart failure in patients with and without cancer are different.


2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
K Victor ◽  
F Bangash ◽  
V Stylianidis ◽  
J Hancock ◽  
M Monaghan ◽  
...  

Abstract   Heart failure (HF) affects an estimated 90 000 people within the UK. As a consequence of ventricular remodelling, mitral regurgitation (MR) is common in patients with HF, further contributing to poor prognosis, frequent hospitalisation, and higher rates of mortality. Conventional treatment options include medical therapy, cardiac resynchronisation and conventional mitral valve surgery, with transcatheter mitral valve repair (TMVR) reserved for symptomatic patients with left ventricular dysfunction and multiple comorbidities, considered high surgical risk. Aim Our objectives were to determine: (1) the proportion of patients with an acute HF admission, ejection fraction (EF) of <50% and moderate or more MR; (2) the effectiveness of optimal medical therapy (OMT) in reducing the severity of MR and symptoms; (3) the number of patients with moderate or more MR, EF <50% and symptoms despite OMT. Method We performed a retrospective analysis of patients who presented with acute HF to two large tertiary centres over a five-year period. Based on a combination of electronic care records, and national registry and mortality data, we determined baseline symptoms, symptom progression, and co-morbidities. Echocardiography data was used to assess the degree of MR and EF. Where patients underwent a subsequent echocardiogram on OMT, the change in the degree of MR, EF and symptoms (NYHA class) was examined. Results Over a five-year period (Jan 2012–Dec 2017), 1884 patients presented with acute HF. Of this cohort, 302 (16%) had moderate or more MR and EF of <50%. Mortality amongst patients with moderate or more MR was 29.9% at one year (compared to 26.9% for those with less than moderate MR, p=0.058). Of this cohort, 45% had sufficient clinical and echocardiographic paired follow up data to enable assessment of the effects of OMT (Age 78±20.78; Male n=76 (56.3%). This analysis showed, despite OMT, all 135 patients still had moderate or more MR. When compared with previous echocardiography data, 11 (8%) patients showed a reduction in the severity of MR which meant 92% (124) of patient with MR either saw no improvement or worsening of their MR severity. Of those with severe MR, 23% (7) demonstrated an improvement in the degree of MR following OMT. Clinically 70 (51.4%) patients had an improvement in symptoms. There was significant improvement in the NYHA class pre and post optimisation of medical therapy (p<0.001) across all grades of MR. Despite OMT, 124 (92%) patients with moderate or more MR and EF <50% remained symptomatic. Conclusions A large portion of patients who present with acute HF have moderate or more MR. Although medical therapy is effective in providing some relief from symptoms, the large majority of patients continue to have moderate or more MR. We propose a portion of these patients are potential candidates for TMVR, and should be considered for further intervention. Funding Acknowledgement Type of funding source: None


2017 ◽  
Vol 52 (3) ◽  
pp. 193
Author(s):  
Halla Hisan Hartoto ◽  
Bambang Subakti Zulkarnain ◽  
Muhammad Aminuddin

BNP secreted by left ventricle as response to wall stress in patient with heart failure. Elevated concentration of NT-pro-BNP correlate with severity of heart failure across all stages of the condition and left ventricle ejection fraction in patient. Several clinical trials have demonstrated that neurohormonal modulation on the RAAS decreases NT-proBNP level and results in favorable outcomes. One of the drug used for blocked RAAS system is ACE inhibitor, decrease of NT-proBNP level show response to therapy include therapy with ACE inhibitors. To analize changes in the levels serum NT-proBNP levels after ace inhibitor therapy in patients with heart failure and monitoring creatinine serum. This study was a observational, prospective, non-randomized trial involving patient age 21-75 years, with NYHA class II-III HF, using ACE inhibitor therapy plus other therapy maximum 3 months before study without ARB or beta blocker. We compared serum NT-pro-BNP and creatinin serum parameters before and after two months treatment with ACE inhibitor. This study conducted in cardiovascular ambulatory patient dr. Soetomo hospital Surabaya. Between August-November 2015, 13 patient (38-63 years, 6 woman, 7 men) include in this study. The mean baseline level of NT-proBNP is 2166.92±1236.73 pg/ml, and creatinin serum 1.023±0.601 mg/dL. The NT-pro-BNP were significantly decreased after two months of treatment with ACE inhibitors 1508.23±651 pg/mL (p=0.025), there were no significant differences creatinin serum between two groups 0.951±0.0365 mg/dL (p=0.111). The results demonstrated the benefits of ACE inhibitor on the neurohormonal profile in patients with HF. If necessary we could measure NT-proBNP level to support prognosis data and monitoring effectivity therapy especially ACE inhibitor which had antiremodelling effect towards patients with HF.


2022 ◽  
Vol 11 (2) ◽  
pp. 439
Author(s):  
Giuseppe De Matteis ◽  
Marcello Covino ◽  
Maria Livia Burzo ◽  
Davide Antonio Della Polla ◽  
Francesco Franceschi ◽  
...  

Acute Heart Failure (AHF)-related hospitalizations and mortality are still high in western countries, especially among older patients. This study aimed to describe the clinical characteristics and predictors of in-hospital mortality of older patients hospitalized with AHF. We conducted a retrospective study including all consecutive patients ≥65 years who were admitted for AHF at a single academic medical center between 1 January 2008 and 31 December 2018. The primary outcome was all-cause, in-hospital mortality. We also analyzed deaths due to cardiovascular (CV) and non-CV causes and compared early in-hospital events. The study included 6930 patients, mean age 81 years, 51% females. The overall mortality rate was 13%. Patients ≥85 years had higher mortality and early death rate than younger patients. Infections were the most common condition precipitating AHF in our cohort, and pneumonia was the most frequent of these. About half of all hospital deaths were due to non-CV causes. After adjusting for confounding factors other than NYHA class at admission, infections were associated with an almost two-fold increased risk of mortality, HR 1.74, 95% CI 1.10–2.71 in patients 65–74 years (p = 0.014); HR 1.83, 95% CI 1.34–2.49 in patients 75–84 years (p = 0.001); HR 1.74, 95% CI 1.24–2.19 in patients ≥85 years (p = 0.001). In conclusion, among older patients with AHF, in-hospital mortality rates increased with increasing age, and infections were associated with an increased risk of in-hospital mortality. In contemporary patients with AHF, along with the treatment of the CV conditions, management should be focused on timely diagnosis and appropriate treatment of non-CV factors, especially pulmonary infections.


2020 ◽  
Vol 13 (Suppl_1) ◽  
Author(s):  
George Cholack ◽  
Joshua Garfein ◽  
Rachel H Krallman ◽  
Delaney Feldeisen ◽  
Kim Eagle ◽  
...  

Background: Readmission reduction initiatives emphasize prompt follow-up post-discharge. Identifying factors that influence early readmission may inform discharge planning. We compared characteristics of heart failure (HF) patients (pts) based on time to readmission to determine which pt characteristics were associated with early readmission. Methods: Pts referred to the BRIDGE clinic following index admission for HF from 2008-2017 were eligible. Demographics and inpatient clinical characteristics were compared between 1) pts who were and were not readmitted within 30 days post-index discharge, and 2) pts who were readmitted early (0-7 days post-discharge) versus late (8-30 days post-discharge). Results: Of 978 HF pts, 226 (23.1%) were readmitted within 30 days. Compared to those not readmitted, 30-day readmits were more likely to be male, white, and have higher NYHA class, longer index stay, ICU admission during index admission, and lower Hgb, higher Cr, and higher BUN during index admission. Among those with a 30 day readmit, 56 (24.8%) were readmitted within 7 days of discharge. Early readmits were more often female (p=0.07) and had index stays in the ICU (p=0.07). Conclusion: Pts readmitted within 30 days had more complicated hospital courses than those not readmitted, and those readmitted early had higher incidences of females and index stays in the ICU. Efforts to define a high risk subset of HF pts likely to be readmitted early and targeting them for enhanced discharge planning is warranted.


EP Europace ◽  
2020 ◽  
Vol 22 (Supplement_1) ◽  
Author(s):  
M Rattka ◽  
A Kuehberger ◽  
T Stephan ◽  
K Weinmann ◽  
D Felbel ◽  
...  

Abstract Background Atrial fibrillation (AF) in patients suffering from heart failure with preserved ejection fraction (HFpEF) is associated with increased symptoms and higher morbidity and mortality. Effective treatment strategies for this patient population have not yet been established. Aim This study aimed to compare the impact of catheter ablation for AF against the current standard therapy on patients with HFpEF. Methods We retrospectively compared clinical outcomes and echocardiographic parameters of patients with AF and HFpEF, who either underwent medical therapy (rate or rhythm control) or catheter ablation for AF. The primary endpoint was a composite of death and hospitalization for any cause and the secondary endpoint a composite of cardiovascular death and cardiovascular hospitalization. Additionally, we assessed NYHA-class, relevant echocardiographic parameters, current ESC diagnosis criteria for HFpEF at baseline and at the end of follow-up, as well as time-to-AF recurrence in both groups. Resolution of HFpEF was estimated, if both left ventricular mass index(LVMI) and E/e’ ratio did not fulfil the ESC-criteria at the end of follow-up.  Results Between January 2013 and December 2018 6.114 patients were treated for AF at our university hospital department. Of those, 752 patients suffered from heart failure symptoms and had echocardiographic diastolic dysfunction. Applying the current ESC-criteria HFpEF was diagnosed in 127 patients. While 59 patients received medical therapy only, catheter ablation for AF was performed in 68 patients. Analysis of AF recurrence in both groups revealed, that in the ablation group 82% of patients and in the medical therapy group only 25% of patients were free from any atrial arrhythmia after one year. Reevaluation of echocardiographic parameters after a mean follow-up period of 39 ± 20 months showed no difference in the medical therapy group, but revealed a significant improvement of the mitral E-wave velocity, E/E’ ratio, LVMI, interventricular septal thickness, e’ velocity and left ventricular diastolic in the catheter therapy group, suggesting reverse remodeling. Reassessment of criteria for HFpEF diagnosis showed resolution of HFpEF in 35% of invasively treated patients compared to 12% of patients who received conservative therapy only (p = 0.002). Moreover, heart failure symptoms, monitored by NYHA-class, significantly worsened in the medical therapy group, whereas there was significant improvement after catheter ablation. Furthermore, assessment of the primary and secondary endpoint displayed significant lower rates of events. Conclusion This is the first study comparing the effect of catheter ablation for AF with the current standard therapy in patients with concomitant HFpEF. Our results suggest that catheter ablation is able to induce reverse remodeling of HFpEF, possibly thereby reducing typical heart failure symptoms and hospitalizations.


2021 ◽  
Vol 22 (Supplement_1) ◽  
Author(s):  
V Vallejo Garcia ◽  
D Gonzalez Calle ◽  
JC Castro Garay ◽  
M Garcia Monsalvo ◽  
J Borrego Rodriguez ◽  
...  

Abstract Funding Acknowledgements Type of funding sources: None. Dilated cardiomyopathy (DCM) is a complex myocardial disease, with a high burden of symptoms and decreased life expectancy. Mitral regurgitation (MR) is a frequent comorbid condition and it is thought that it deteriorates left ventricle (LV) volume and ejection fraction. Guideline directed medical therapy for heart failure improves myocardial function and decreases morbidity and mortality, and there is ongoing interest in the application of novel percutaneous techniques like mitral edge-to-edge repair or resynchronization therapy in order to decrease cardiovascular events (CVE).  Our objective was to analyze if MR is associated with late gadolinium enhancement (LGE), left ventricle (LV) or right ventricle (RV) dysfunction and cardiovascular events in patients with DCM. A retrospective, case control study was designed including 173 patients (mean age 60 years, 73% males, 36% dyslipemia, 30% diabetes, 20% hypertension, 8% current smokers) with diagnosis of DCM and cardiac magnetic resonance study in our center between 2014-2020 according to the latest European Society of Cardiology (ESC) definition and the latest updated position paper. Clinical data, use of guideline directed medical therapy and devices, cardiac imaging tests, mortality and CVE were collected and analyzed. Mitral regurgitation was calculated on CMR and was included if it was more than mild.  After a mean follow up of 18 months, 53 patients (30%) suffered a CVE (16% heart failure, 14% incident arrythmia, 0,5% stroke 8% death). Patients with MR (n= 48; 28%) had worse LV ejection fraction (-4,8% mean; p=,02), worse RV ejection fraction (-5,5% mean; p=,03), more hospitalizations due to heart failure (OR 1,78; p=,01), had a trend toward increased mortality although it was not statistically significant (p=,01) and a trend towards late gadolinium enhancement (p,13). There was no association with incident arrythmias (p=,5) or stroke (p=,9)  In multivariate analyses (log regression, multiple linear regression) MR was maintained as an independent predictor of worse RV ejection fraction (mean -3,9%; p=,03), and hospitalization for heart failure (OR 3,8; p=,043). There was also a trend toward increased mortality (p=,1) in our population. Figure.  In patients with DCM, MR is associated with decreased LV and RV ejection fraction, hospitalization due to heart failure and has a tendency to be associated with mortality. Specific treatment for mitral regurgitation, including percutaneous edge-to-edge repair or surgery according to current guidelines, might decrease the severity of MR in these patients and that could lead to an improved prognosis and less morbidity. Further studies should review the impact of an interventional strategy in mitral regurgitation in patients with DCM. Abstract Figure. Mitral regurgitation in DCM: prognosis.


2021 ◽  
Vol 28 (4) ◽  
pp. 34-44
Author(s):  
N. N. Ilov ◽  
D. G. Tarasov

A systematic review and meta-analysis of studies providing information on the use of intracardiac electrophysiological study (EPS) to stratify the risk of ventricular tachyarrhythmia (VT) in patients with non-ischemic chronic heart failure with low left ventricle ejection fraction (HFrEF). Relevant publications were searched until 20.01.2021 by two independent researchers in major search engines, electronic archives of clinical research, and open access preservatives repository. The end point considered was an episode of sudden cardiac death or sustained paroxysm of VT, or an appropriate electrotherapy of an implanted cardiac defibrillator. Ten clinical trials with 608 relevant patients (mean age: 51.5 ± 12 years; mean left ventricle EF: 26.8±8.5%, NYHA class: I - 17.7%; II - 33.7%; III - 35.9%, IV - 12.7%) were selected. The end point was registered in 92 patients (15.1%): in 47 patients (43.9%) with previously induced VT during EPS and in 45 patients (8.9%) without VT. The diagnostic odds ratio was 5.57 (2.27-13.63). The combined sensitivity and specificity of the EPS were 42% (26-61%) and 88% (83-92%) respectively. The results indicate the potential of EPS to stratify the arrhythmic risk in patients with non-ischemic HFrEF.


Sign in / Sign up

Export Citation Format

Share Document