CBS - The 17th Left Main & Coronary Bifurcation Summit, CBS2025

科学研究

Empagliflozin Increases Cardiac Energy Production in Diabetes - Novel Translational Insights Into the Heart Failure Benefits of SGLT2 Inhibitors Impact of Intravascular Ultrasound-Guided Drug-Eluting Stent Implantation on Patients With Chronic Kidney Disease: Subgroup Analysis From ULTIMATE Trial Sequence variations in PCSK9, low LDL, and protection against coronary heart disease The Role of the Pericardium in Heart Failure: Implications for Pathophysiology and Treatment Atherosclerosis — An Inflammatory Disease Clinical Risk Factors and Atherosclerotic Plaque Extent to Define Risk for Major Events in Patients Without Obstructive Coronary Artery Disease: The Long-Term Coronary Computed Tomography Angiography CONFIRM Registry Systemic microvascular dysfunction in microvascular and vasospastic angina Major Bleeding Rates in Atrial Fibrillation Patients on Single, Dual, or Triple Antithrombotic Therapy 2019 ACC/AHA/ASE Advanced Training Statement on Echocardiography (Revision of the 2003 ACC/AHA Clinical Competence Statement on Echocardiography): A Report of the ACC Competency Management Committee Sleep quality and risk of coronary heart disease-a prospective cohort study from the English longitudinal study of ageing

Sort by hits |<<... 89 90 91 92 93 94 95 ...>>|

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