6133Profile of cardiomyopathy patients in Cape Town - pilot phase the IMHOTEP Study

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
S M Kraus ◽  
P Samuels ◽  
N Laing ◽  
M Ntsekhe ◽  
A Chin ◽  
...  
Keyword(s):  
Age Of Onset ◽  
Communicable Disease ◽  
Beta Blockers ◽  
Nyha Class ◽  
Left Ventricular ◽  
Continuous Variables ◽  
Class Iii ◽  
Optimal Dosing ◽  
History Of ◽  
Centre Hospital

Abstract Background Cardiomyopathies pose a great challenge because of poor prognosis and high prevalence in LMIC with limited access to specialised care. Little is known about the clinical profile of cardiomyopathy in Africa. Purpose Delineation of clinical presentation and cardiovascular magnetic resonance (CMR) phenotypes of cardiomyopathy. Method The African Cardiomyopathy and Myocarditis Registry Program (IMHOTEP) is a prospective multi-centre, hospital-based study and aims to investigate the clinical characteristics, aetiology, genetics, management and outcomes of cardiomyopathies in Africans. Results Assessment of the first 99 adult cases showed that dilated cardiomyopathy (DCM; n=67) was commonest, followed by hypertrophic (HCM; n=13), left ventricular noncompaction (LVNC; n=11), restrictive (RCM; n=4) and arrhythmogenic (ARVC; n=4) cardiomyopathies. Idiopathic DCM (22%) and peripartum cardiomyopathy (16%) accounted for the majority (Figure). A family history of cardiomyopathy or SCD was reported in 20% of cases. Mean age of presentation was 37±12 years. Most patients (96%) were symptomatic at presentation. NYHA class III/IV was more frequently seen in DCM (61%), RCM (50%) and LVNC (64%), whereas syncope was more common in ARVC (50%) and HCM (23%). VT and aborted cardiac arrest were reported in 7% and 3%, respectively. Onset of symptoms in the peripartum period was observed in 47% of women. Beta-blockers and ACE-inhibitors were prescribed in 77% and 78%, respectively, however optimal dosing was achieved in ≤14% of patients at a median time of 5.4 months after symptom onset. CMR was performed in 67 (68%) cases (Table) and contributed diagnostically in a third of cases. Late gadolinium enhancement (LGE) was observed in 92%. In DCM, linear mid-wall and subendocardial patterns of LGE were seen in 95% and 8% of patients respectively – a much higher percentage than previously reported in the literature. CMR volumetric and functional assessment DCM, n=38 HCM, n=11 ARVC, n=3 RCM, n=4 LVNC, n=11 LVEF (%) 27±15 78±7 55±5 52±7 32±17 LVEDV/BSA (ml/m2) 150±40 80±17 98±12 59±13 155±52 LV mass/BSA (g/m2) 82±23 102±35 74±3 71±14 88±31 RVEF (%) 34±15 68±10 22±15 49±18 33±15 RVEDV/BSA (ml/m2) 104±37 68±15 189±27 56±8 106±51 All continuous variables presented as mean ± standard deviation. Cardiomyopathy diagnosis (n=99) Conclusion IMHOTEP is the first multi-centre registry for cardiomyopathy in Africa. Preliminary data suggests an earlier age of onset with female predominance compared to other cohorts, and DCM is the predominant form of cardiomyopathy in Africa. Acknowledgement/Funding NEWTON FUND NON-COMMUNICABLE DISEASE - South African Medical Research Council (SAMRC/GSK)

228Long-term safety and effectiveness of mavacamten in symptomatic obstructive hypertrophic cardiomyopathy (oHCM) patients (pts): update from PIONEER open-label extension (PIONEER-OLE) study

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
A Wang ◽  
S B Heitner ◽  
D Jacoby ◽  
S Lester ◽  
L Fang ◽  
...  
Keyword(s):  
Hypertrophic Cardiomyopathy ◽  
Beta Blockers ◽  
Nyha Class ◽  
Study Drug ◽  
Class Ii ◽  
Left Ventricular ◽  
P Value ◽  
Class Iii ◽  
Open Label ◽  
Obstructive Hypertrophic Cardiomyopathy

Abstract Background In a phase 2 PIONEER-HCM study, pts with symptomatic, obstructive hypertrophic cardiomyopathy (oHCM) showed improvement in left ventricular outflow tract (LVOT) obstruction, exercise capacity, and symptoms after 12 wk of treatment with the novel myosin modulator, mavacamten (Mava). Purpose To examine the long-term safety and effectiveness of Mava in PIONEER-OLE study Methods PIONEER-OLE (NCT03496168) is an ongoing 2-y multicenter study for adults with symptomatic oHCM who completed PIONEER-HCM (NCT02842242). The starting dose of Mava is 5 mg/d with titration at wk 6 to an individualized therapeutic dose (5, 10, or 15 mg). Evaluations are at wk 4, 6, 8, 12 and every 12 wk thereafter to monitor LV ejection fraction (LVEF), LVOT gradient, New York Heart Association (NYHA) class, NT-proBNP, drug concentration, and safety. Results 13 pts (mean age, 57.8 y; 9 male; 12 on beta-blockers) were enrolled. Mean baseline LVOT obstruction and LVEF, and wk 12 changes from baseline, were similar to those in PIONEER-HCM (Table). Mava significantly reduced resting and provoked LVOT gradients and NT-proBNP at wk 12 and 24 compared with baseline (P<0.004). Of 10 pts who reached wk 24, 8 reported improvement in NYHA class (1 improved Class III to II; 7 improved Class II to I), and 2 pts remained Class II. Mava has been well tolerated up to 40 wk; 31 adverse events (AEs; 22 mild, 5 moderate) were reported in 8 pts; 1 pt had 3 severe and 1 serious AE (cholangiocarcinoma); all AEs were unrelated to study drug. Results from PIONEER-OLE Parameter PIONEER-HCMa PIONEER-OLE Baseline Wk 12 Baselineb Wk 12 Change at Wk 12 Wilcoxon Signed Wk 24 Change at Wk 24 Wilcoxon Signed Mean ± SD Mean ± SD Mean ± SD Mean ± SD Mean ± SD Rank Mean ± SD Mean ± SD Rank (n=13) (n=13) (n=13)c (n=12)c (n=12)c P value (n=10)c (n=10)c P value LVOT Rest gradient, mmHg 69.7±53.9 27.8±31.3 67.3±42.8 12.0±5.4 −57.9±43.2 0.0005 10.5±4.8 −66.6±42.4 0.0020 LVOT Valsalva gradient, mmHg 93.7±55.6 36.8±37.5 89.9±30.7 (n=12) 23.6±20.0 −66.4±35.3 (n=11) 0.0020 21.1±11.5 −67.3±33.5 (n=9) 0.0039 LVEF, % 73.0±5.6 64.6±10.5 72.0±4.9 67.6±7.2 −4.4±5.5 0.0269 68.2±6.5 −3.2±3.3 0.0195 NT-proBNP, pg/mL 1601.3±2782 (n=12) 684±980 1836±2886 181±211 −1759±2789 0.0005 170±225 −2128±3104 0.0039 Data extraction date January 24, 2019. aCombined results shown for pts from PIONEER-HCM originally in cohort A (n=5) and cohort B (n=8). bBaseline in PIONEER-OLE occurred 6–18 months after completion of PIONEER-HCM. cNumber of pts with data available for analysis, unless otherwise specified. Conclusion Despite management with current therapies, pts enrolled in PIONEER-OLE with similar levels of obstruction and hypercontractility as in PIONEER-HCM. In this longest observation period, Mava significantly reduced obstruction (LVOT gradient) in pts with oHCM beyond standard HCM therapy, while maintaining normal LVEF and improving symptoms. Acknowledgement/Funding MyoKardia

scholarly journals P-162 Transesophageal left ventricular pacing with different pacing mode in heart failure patients with NYHA class III

EP Europace ◽  
2003 ◽  
Vol 4 (Supplement_2) ◽  
pp. B105-B105
Author(s):  
M. Heinke ◽  
H. Kuhnert ◽  
R. Surber ◽  
G. Dannberg ◽  
H.R. Figulla ◽  
...  
Keyword(s):  
Heart Failure ◽  
Nyha Class ◽  
Left Ventricular ◽  
Ventricular Pacing ◽  
Class Iii ◽  
Heart Failure Patients ◽  
Pacing Mode ◽  
Left Ventricular Pacing

Abstract 14647: Stress Echocardiography Predicts Heart Failure Progression and Alters Management Strategies in Patients with Hypertrophic Cardiomyopathy

Circulation ◽  
2014 ◽  
Vol 130 (suppl_2) ◽  
Author(s):  
Ethan J Rowin ◽  
Barry J Maron ◽  
Iacopo Olivotto ◽  
Susan A Casey ◽  
Anna Arretini ◽  
...  
Keyword(s):  
Heart Failure ◽  
Nyha Class ◽  
Management Strategies ◽  
Left Ventricular ◽  
Advanced Heart Failure ◽  
Outflow Tract ◽  
Class I ◽  
Class Iii ◽  
Outflow Obstruction ◽  
Heart Failure Progression

Background: One-third of HCM patients without left ventricular outflow tract obstruction under resting conditions have the propensity to develop an outflow gradient with physiologic exercise. However, the natural history and management implications of exercise-induced (i.e., provocable) obstruction is unresolved. Methods: We prospectively studied 533 consecutive HCM patients without outflow obstruction at rest (<30mmHg) who underwent a symptom limiting stress (exercise) echocardiogram to assess development of outflow obstruction following physiologic provocation and followed for 6.5 ± 2.0 years. Of the 533 patients, obstruction ≥ 30 mmHg was present following exercise in 262 patients (49%; provocable obstruction), and was absent both at rest and with exercise in 271 (51%; nonobstructive). Results: Over the follow-up period, 43 out of 220 (20%) HCM patients with provocable obstruction and baseline NYHA class I/II symptoms developed progressive limiting heart failure symptoms to class III/IV, compared to 24 of 249 (10%) nonobstructive patients. Rate of heart failure progression was significantly greater in patients with provocable obstruction vs. nonobstructive patients (3.1%/year vs. 1.5%/year; RR=2.0, 95% CI of 1.3-3.2; p=0.003). However, the vast majority of patients with provocable obstruction who developed advanced heart failure symptoms achieved substantial improvement in symptoms to class I / II following relief of obstruction with invasive septal reduction therapy (n=30/32; 94%). In comparison, the majority of nonobstructive patients who developed advanced heart failure remained in class III/IV (16/24;67%), including 10 (42%) currently listed for heart transplant. Conclusions: Stress (exercise) echocardiogram identifies physiological provocable outflow tract obstruction in HCM, and is a predictor of future risk for progressive heart failure (3.1%/year), in patients who become candidates for invasive septal reduction therapy. Therefore, exercise echocardiography should be considered in all HCM patients without obstruction under resting conditions.

scholarly journals Incidence of Cardiotoxicity and Validation of the Heart Failure Association- International Cardio-Oncology Society risk stratification Tool in Patients Treated with Trastuzumab for HER2-Positive Early Breast Cancer.

2021 ◽  
Author(s):  
Nicolò Matteo Luca Battisti ◽  
Maria Sol Andres ◽  
Karla A Lee ◽  
Tharshini Ramalingam ◽  
Tamsin Nash ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Heart Failure ◽  
Early Breast Cancer ◽  
Nyha Class ◽  
Left Ventricular ◽  
Left Ventricular Ejection ◽  
Class Iii ◽  
Her2 Positive ◽  
Ventricular Ejection Fraction ◽  
Very High

Abstract PurposeTrastuzumab improves survival in patients with HER2+ early breast cancer. However, cardiotoxicity remains a concern, particularly in the curative setting, and there are limited data on its incidence outside of clinical trials. We retrospectively evaluated the cardiotoxicity rates (left ventricular ejection fraction [LVEF] decline, congestive heart failure [CHF], cardiac death or trastuzumab discontinuation) and assessed the performance of a proposed model to predict cardiotoxicity in routine clinical practice.MethodsPatients receiving curative trastuzumab between 2011-2018 were identified. Demographics, treatments, assessments and toxicities were recorded. Fisher’s exact test, chi-squared and logistic regression were used.Results931 patients were included in the analysis. Median age was 54 years (range 24-83) and Charlson comorbidity index 0 (0-6), with 195 patients (20.9%) aged 65 or older. 228 (24.5%) were smokers. Anthracyclines were given in 608 (65.3%). Median number of trastuzumab doses was 18 (1-18). The HFA-ICOS cardiovascular risk was low in 401 patients (43.1%), medium in 454 (48.8%), high in 70 (7.5%) and very high in 6 (0.6%).Overall, 155 (16.6%) patients experienced cardiotoxicity: LVEF decline≥10% in 141 (15.1%), falling below 50% in 55 (5.9%), CHF NYHA class II in 42 (4.5%) and class III-IV in 5 (0.5%) and discontinuation due to cardiac reasons in 35 (3.8%). No deaths were observed.Cardiotoxicity rates increased with HFA-ICOS score (14.0% low, 16.7% medium, 30.3% high/very high; p=0.002). ConclusionsCardiotoxicity was relatively common (16.6%), but symptomatic heart failure on trastuzumab was rare in our cohort. The HFA-ICOS score identifies patients at high risk of cardiotoxicity

scholarly journals Massive Myocardial Calcification—A Heart Of Stone!

2021 ◽  
Author(s):  
Mariana Tinoco ◽  
Pedro Von Hafe ◽  
Sérgio Leite ◽  
Margarida Oliveira ◽  
Olga Azevedo ◽  
...  
Keyword(s):  
Troponin I ◽  
Nyha Class ◽  
Mitral Annulus ◽  
Left Ventricular ◽  
Oral Rehydration ◽  
Myocardial Calcification ◽  
Septal Thickness ◽  
Mitral Annulus Calcification ◽  
History Of ◽  
History Of Obesity

Abstract A 71-year-old female was admitted in the emergency room after effort-related syncope. She had past medical history of obesity and hypertension treated with lercanidipine. No relevant family history. Physical examination revealed systolic murmur (grade 2/6). ECG showed sinus rhythm and left bundle brunch block (Supplementary figure). Lab results were unremarkable including troponin I. Transthoracic echocardiography (TTE) revealed moderate left ventricular (LV) hypertrophy [septal thickness 14 mm (normal: 6–9mm)], extensive mitral annulus calcification (MAC) with exuberant myocardial calcification at the level of posterior leaflet that invaded adjacent LV walls, systolic anterior motion of the anterior mitral leaflet causing LV outflow tract (LVOT) obstruction (maximum gradient 34 mmHg) and moderate mitral regurgitation (MR) (Panel A). Exercise echocardiogram provoked LVOT gradient &gt;100mmHg and severe MR. Continuous ECG monitoring during 13 days demonstrated no arrhythmic events. Cardiac CT showed multiple calcifications extending from mitral annulus to LV anterior and lateral walls and cardiac MRI was compatible with caseous MAC (Panels B-F). Coronary angiography showed 50% stenosis of mid left anterior descending artery. Normal thoracic CT and ACE, and negative IGRA excluded sarcoidosis and tuberculosis. Comprehensive study, including calcium metabolism and autoantibodies, excluded metabolic and inflammatory aetiologies of myocardial calcification, which was assumed as dystrophic in the context of MAC. No syncope occurred after bisoprolol 2.5 mg, oral rehydration and discontinuation of lercanidipine. However, rest and exercise TTE failed to show improvement of LVOT gradient or MR and patient remained on NYHA class II-III, despite maximal tolerated dose of bisoprolol (5 mg), being therefore referred to cardiac surgery.

Abstract 19346: Peak Oxygen Consumption Predicts Outcome in Hypertrophic Cardiomyopathy

Circulation ◽  
2014 ◽  
Vol 130 (suppl_2) ◽  
Author(s):  
Carla Contaldi ◽  
Raffaella Lombardi ◽  
Alessandra Giamundo ◽  
Sandro Betocchi
Keyword(s):  
Heart Failure ◽  
Oxygen Consumption ◽  
Hypertrophic Cardiomyopathy ◽  
Nyha Class ◽  
Left Ventricular ◽  
Exercise Intolerance ◽  
Peak Oxygen Consumption ◽  
Class Iii ◽  
Asymptomatic Patients

Introduction: Peak oxygen consumption (VO 2 ) has a strong and independent prognostic value in systolic heart failure; in contrast no data support its prognostic role in hypertrophic cardiomyopathy (HCM). Hypothesis: We assess if peak VO 2 is a long-term predictor of outcome in HCM. Methods: We studied 92 HCM patients (40±15 years). Peak VO 2 was expressed as percentage (%) of the predicted value. Follow up was 76±57 months. The primary composite endpoint (CE) was atrial fibrillation, progression to NYHA class III or IV, myotomy-myectomy (MM), heart transplantation (HT) and cardiac death. An ancillary endpoint (HFE) included markers of heart failure (progression to NYHA class III or IV, MM and HT). Results: At baseline, 62% of patients were asymptomatic, 35% NYHA class II and 3% NYHA class III; 26% had left ventricular outflow tract obstruction. During follow up, 30 patients met CE with 43 events. By multivariate Cox survival analysis, we analyzed 2 models, using the CE, and in turn HFE. For CE, maximal left atrial diameter (LAD) (HR: 1.12; 95% CI: 1.04 to 1.22), maximal wall thickness (MWT) (HR: 0.14; 95% CI: 1.04 to 1.23) and % predicted peak VO 2 (HR: -0.03; 95% CI: 0.95 to 0.99) independently predicted outcome (overall, p<0.0001). For HFE, maximal LAD (HR:0.31; 95% CI: 1.09 to 1.70), MWT (HR: 0.35; 95% CI: 1.08 to 1.84) and % predicted peak VO 2 (HR: -0.06; 95% CI: 0.89 to 0.98) independently predicted outcome (overall, p<0.0001). Only 19% of mildly symptomatic or asymptomatic patients with % predicted peak VO 2 >80% had events, as opposed to 53% of them with % predicted peak VO 2 < 55% (p= 0.04). Event-free survival for both endpoints was significantly lower in patients with % predicted peak VO 2 < 55% as compared to those with it between 55 and 80 and >80% , Figure. Conclusion: In mildly or asymptomatic patients severe exercise intolerance may precede clinical deterioration. In HCM, peak VO 2 provides excellent risk stratification with a high event rate in patients with % predicted value <55%.

P320Heart failure with mid-range (HFmrEF) or recovered (HFrecEF) ejection fraction: differential determinants of transition

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
R De Maria ◽  
F Macera ◽  
M Gorini ◽  
I Battistoni ◽  
M Iacoviello ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Ejection Fraction ◽  
Clinical Characteristics ◽  
Nyha Class ◽  
Multivariable Logistic Regression Analysis ◽  
Class Iii ◽  
Mild Disease ◽  
Lower Likelihood ◽  
History Of

Abstract Background Heart failure with mid-range ejection fraction (HFmrEF) has been identified as a multi-faceted phenotype that may encompass both patients with mild disease or those who from previous HFrEF recover EF (HFrecEF) Purpose To describe clinical characteristics and factors associated with phenotype transition at follow-up. Methods From 2009 to 2016, 1194 patients with baseline EF<50% and a second echocardiographic determination during clinically stability at a median of 6 months were enrolled in the IN-CHF Registry. Based on EF at enrollment, 335 (28%) had HFmrEF and 859 (72%) had HFrEF. We compared baseline clinical characteristics and predictors associated with follow-up reclassification to HFmrEF or full EF recovery Results When compared to HFrEF patients, those with HFmrEF had less often an ischemic etiology, advanced symptoms and a HF admission in the previous year. No other differences were found in clinical characteristics and drug therapy (Table). At a median follow-up of 6 months, 30% of HFrEF patients improved EF by 14 (9) units: 21% showed partial EF recovery (transition to HFmrEF) and 9% had full EF recovery. Conversely among HFmrEF patients 22% improved EF, by 9 (5) units, to full recovery, and 18% deteriorated by 1.5 (5.5) units sloping to HFrEF. By multivariable logistic regression analysis, variables associated with EF recovery at 6-month follow-up differed between baseline phenotypes. Within HFrEF, ischemic etiology (OR 0.46, 95% CI 0.33–0.64) and NYHA class III-IV symptoms (OR 0.57, 95% CI 0.38–0.68) were associated with a lower likelihood of EF recovery, while a history of HF<6 month correlated with a higher likelihood of EF recovery (OR 2.44, 95% CI 1.76–3.39). Within HFmrEF, while ischemic etiology (OR 0.66, 95% CI 0.19–0.68) was also associated with a lower likelihood of EF recovery, a history of atrial fibrillation at enrollment correlated with higher likelihood of EF recovery (OR 2.66, 95% CI 1.37–5.17) by 6 month-follow-up. At a median follow-up of 36+28 months mortality was 4.6% vs 6.9% in HFrecEF vs non-recovered patients (log rank p=0.08). Baseline characteristics HFrEF vs HFmrEF Conclusions HFmrEF patients showed a less severe clinical picture than HFrEF patients, but had EF recovery less often. EF improvement is negatively associated with ischemic etiology in both phenotypes, and positively associated with atrial fibrillation in HFmrEF and a short history of HF in HFrEF.

scholarly journals Noncompaction and Takotsubo Syndrome in a Neuromuscular Disorder

2019 ◽  
Vol 2019 ◽  
pp. 1-3
Author(s):  
Josef Finsterer ◽  
Claudia Stöllberger ◽  
Walter Benedikt Winkler
Keyword(s):  
Chest Pain ◽  
Beta Blockers ◽  
Liver Cyst ◽  
Neuromuscular Disorder ◽  
Sudden Onset ◽  
Left Ventricular ◽  
Takotsubo Syndrome ◽  
Troponin Elevation ◽  
History Of ◽  
St Elevation

Background. Takotsubo syndrome (TTS) in patients with left ventricular hypertrabeculation/noncompaction (LVHT) has been reported in four patients, and a TTS plus LVHT plus a neuromuscular disorder (NMD) was only reported once so far. Here, we present the fifth patient with LVHT and TTS and the second patient with LVHT, TTS, and a NMD. Methods and Results. The patient is a 68 yo female hobby choir singer with a history of skin dermatofibroma, skin fibrokeratoma, arterial hypertension, hyperlipidemia, hypothyroidism, anemia, hyponatremia, diverticulosis, LVHT detected at age 60 y, five syncopes, a liver cyst, and carotid endarterectomy 2 months prior to admission because of sudden-onset chest pain. Workup revealed ST elevation, troponin elevation, and mild coronary artery sclerosis. Ventriculography and transthoracic echocardiography (TTE) showed the apical type of a TTS. ECG normalised within 10 w and TTE within 6 w under beta-blockers and ATII-blockers. The TTS was triggered by being offended of being unable to sing anymore after endarterectomy. Neurological workup suggested the presence of a NMD. Conclusions. This case shows that LVHT occurs in NMD patients and that patients with LVHT and a NMD may develop a TTS. Whether patients with LVHT and a NMD are particularly prone to develop a TTS requires further confirmation. NMD patients with LVHT should avoid stress not to trigger a TTS.

scholarly journals Utilization and Dose Optimization of Angiotensin-Converting Enzyme Inhibitors among Heart Failure Patients in Southwest Ethiopia

2019 ◽  
Vol 2019 ◽  
pp. 1-8 ◽  
Author(s):  
Yirga Legesse Niriayo ◽  
Kabaye Kumela ◽  
Kidu Gidey ◽  
Mulugeta Tarekegn Angamo
Keyword(s):  
Heart Failure ◽  
Enzyme Inhibitors ◽  
Nyha Class ◽  
Angiotensin Converting Enzyme Inhibitors ◽  
Converting Enzyme ◽  
Class Iii ◽  
Converting Enzyme Inhibitors ◽  
Heart Failure Patients ◽  
Optimal Dosing ◽  
Previous Hospitalization

Background. Optimal use of angiotensin-converting enzyme inhibitors (ACEIs) is crucial to improve the treatment outcome in heart failure patients. However, little is known about the optimal use of ACEIs among heart failure patients in our setting. Therefore, our study aimed to investigate the utilization and optimal dosing of ACEIs and associated factors in heart failure patients. Method. A cross-sectional study was conducted on randomly selected patients with heart failure between February 2016 and June 2016 at ambulatory care clinic of Jimma University Medical Center, Ethiopia. Data were collected through patient interview and review of medical records. Binary logistic regression analysis was done to identify factors associated with utilization and optimal dosing of ACEIs. Results. A total of 308 patients were included in the final analysis of this study. The mean (±standard deviation) age of the patients was 52.3 ±15.5 years. Out of the total, 74.7% of the patients were receiving ACEIs. Among the patients who were receiving ACEIs, only 35.7% were taking optimal dose. New York Heart Association (NYHA) class III (Adjusted odds ratio (AOR):0.12, 95% confidence interval (CI):0.02–0.98), valvular heart disease (AOR: 0.27, 95% CI: 0.13-0.56), hypertension (AOR: 5.82, 95% CI: 2.16-15.71), and diabetes mellitus (AOR: 3.84, 95% CI: 1.07-13.86) were significantly associated with the use of ACEIs, whereas age ≥65 (AOR: 2.61, 95%CI: 1.20-5.64), previous hospitalization for heart failure (AOR: 2.08, 95%CI: 1.11-3.92), diuretic use (AOR: 5.60, 95%CI: 2.75-11.40), and dose of furosemide >40mg (AOR: 9.80, 95%CI: 3.00-31.98) were predictors of suboptimal dosing of ACEIs. Conclusion. Although majority of patients were receiving ACEIs, only about one-third were using optimal dosage. Valvular heart disease and NYHA class III were negatively associated with the use of ACEIs while previous hospitalization for heart failure, old age, diuretic use, and diuretic dose were predictors of suboptimal dosing of ACEIs. Therefore, more effort needs to be done to minimize the potentially modifiable risk factors of suboptimal use of ACEIs therapy in heart failure patients.

Phase III trial of non-pegylated liposomal doxorubicin (M) in combination with trastuzumab (T) and paclitaxel (P) in HER2+ metastatic breast cancer (MBC).

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. 517-517 ◽  
Author(s):  
Lorena De La Pena ◽  
Javier Cortes ◽  
Alexey Manikhas ◽  
Laslo Roman ◽  
Vladimir Semiglazov ◽  
...  
Keyword(s):  
Nyha Class ◽  
Metastatic Breast ◽  
Pegylated Liposomal Doxorubicin ◽  
Progression Free Survival ◽  
Left Ventricular ◽  
Phase Iii ◽  
Left Ventricular Ejection ◽  
Class Iii ◽  
Ventricular Ejection Fraction ◽  
Phase Iii Trial

517 Background: M in combination with T has shown promising activity and cardiac safety in MBC patients (pts). We conducted a randomized Phase III trial of first-line M plus T and P (MTP) versus T plus P (TP) in HER2+ MBC pts. Methods: Pts with HER2+ (by FISH) MBC ≥ 18 years and ECOG 0-1, who had received no prior chemotherapy for metastatic disease, were eligible. Left ventricular ejection fraction should be within normal institutional limits. Prior (neo-) adjuvant anthracyclines, T or P were permitted, if completed >1 year before the start of the study. Pts received M 50 mg/m2 q3w for 6 cycles, T 4 mg/kg loading dose followed by 2 mg/kg qw, and P 80 mg/m2qw, or T+P at the same doses until progression or toxicity. Primary outcome was progression-free survival (PFS). Enrollment of 332 pts would provide 80% power with a 5% significance to detect an improvement in PFS with MTP, assuming a median PFS of 8 months in TP and a hazard ratio (HR) of 0.70. Results: 363 pts enrolled (MTP 181, TP 183), 360 received treatment. The two groups were well balanced for demographics, pretreatment characteristics and extent of disease. One third of the pts had prior exposure to anthracyclines, but almost none to trastuzumab (1% and 2% in MTP and TP arms, respectively). Six cycles of M could be given to 72% of the pts. With a median follow-up of 31 months, median PFS was 16.1 and 14.5 months with MTP and TP, respectively (HR 0.84, P=0.174). In pts with ER and PR-negative tumors, PFS was 20.7 and 14.0 months, respectively (HR, 0.68; 95% CI 0.47–0.99). Median overall survival (OS) was 33.6 and 28.9 months, respectively (HR, 0.79, P=0.083). In ER and PR-negative tumors, OS was 38.2 and 27.9 months, respectively (HR, 0.63; 95% CI 0.42–0.93). The incidence of NYHA Class III/IV congestive heart failure was 3% with MTP and there were 2 cardiac deaths with TP. The frequency of adverse events was higher with MTP, especially myelosuppression, stomatitis and gastrointestinal intolerance. Conclusions: The trial failed to demonstrate a significant clinical improvement with the addition of M to TP. The clinical benefit observed in an exploratory analysis in the ER and PR-negative population deserves consideration for further clinical trials. Clinical trial information: NCT00294996.

Sign in / Sign up

Export Citation Format

Share Document