左主干暨冠状动脉分叉病变峰会，CBS2019 - CBS 2019

充血性心力衰竭

Fluid Volume Overload and Congestion in Heart Failure: Time to Reconsider Pathophysiology and How Volume Is Assessed Phenotypic Refinement of Heart Failure in a National Biobank Facilitates Genetic Discovery 中国心力衰竭诊断和治疗指南2018 sST2 Predicts Outcome in Chronic Heart Failure Beyond NT−proBNP and High-Sensitivity Troponin T 2018 ACC/AHA/HRS Guideline on the Evaluation and Management of Patients With Bradycardia and Cardiac Conduction Delay: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines and the Heart Rhythm Society The Future of Biomarker-Guided Therapy for Heart Failure After the Guiding Evidence-Based Therapy Using Biomarker Intensified Treatment in Heart Failure (GUIDE-IT) Study Effect of Luseogliflozin on Heart Failure With Preserved Ejection Fraction in Patients With Diabetes Mellitus Phenomapping for Novel Classification of Heart Failure With Preserved Ejection Fraction Cardiovascular biomarkers in patients with acute decompensated heart failure randomized to sacubitril-valsartan or enalapril in the PIONEER-HF trial Novel percutaneous interventional therapies in heart failure with preserved ejection fraction: an integrative review

Sort by hits |<< 1 2 3 4 5 6 7 ...>>|

Clinical TrialVolume 6, Issue 10, October 2018

JOURNAL：JACC: Heart Failure Article Link

A Randomized Controlled Trial to Evaluate the Safety and Efficacy of Cardiac Contractility Modulation

Abraham WT, Kuck KH, FIX-HF-5 Investigators and Coordinators. Keywords: heart failure; exercise tolerance; peak Vo2; QRS duration; quality of life

ABSTRACT

OBJECTIVES - This study sought to confirm a subgroup analysis of the prior FIX-HF-5 (Evaluate Safety and Efficacy of the OPTIMIZER System in Subjects With Moderate-to-Severe Heart Failure) study showing that cardiac contractility modulation (CCM) improved exercise tolerance (ET) and quality of life in patients with ejection fractions between 25% and 45%.

BACKGROUND - CCM therapy for New York Heart Association (NYHA) functional class III and IV heart failure (HF) patients consists of nonexcitatory electrical signals delivered to the heart during the absolute refractory period.

METHODS - A total of 160 patients with NYHA functional class III or IV symptoms, QRS duration <130 ms, and ejection fraction ≥25% and ≤45% were randomized to continued medical therapy (control, n = 86) or CCM (treatment, n = 74, unblinded) for 24 weeks. Peak Vo2 (primary endpoint), Minnesota Living With Heart Failure questionnaire, NYHA functional class, and 6-min hall walk were measured at baseline and at 12 and 24 weeks. Bayesian repeated measures linear modeling was used for the primary endpoint analysis with 30% borrowing from the FIX-HF-5 subgroup. Safety was assessed by the percentage of patients free of device-related adverse events with a pre-specified lower bound of 70%.

RESULTS - The difference in peak Vo2 between groups was 0.84 (95% Bayesian credible interval - 0.123 to 1.552) ml O2/kg/min, satisfying the primary endpoint. Minnesota Living With Heart Failure questionnaire (p < 0.001), NYHA functional class (p < 0.001), and 6-min hall walk (p = 0.02) were all better in the treatment versus control group. There were 7 device-related events, yielding a lower bound of 80% of patients free of events, satisfying the primary safety endpoint. The composite of cardiovascular death and HF hospitalizations was reduced from 10.8% to 2.9% (p = 0.048).

CONCLUSIONS - CCM is safe, improves exercise tolerance and quality of life in the specified group of HF patients, and leads to fewer HF hospitalizations. (Evaluate Safety and Efficacy of the OPTIMIZER System in Subjects With Moderate-to-Severe Heart Failure; NCT01381172).

科研文章

荐读文献

A Randomized Controlled Trial to Evaluate the Safety and Efficacy of Cardiac Contractility Modulation

ABSTRACT