scholarly journals A Randomized Controlled Trial to Evaluate the Safety and Efficacy of Cardiac Contractility Modulation in Patients With Moderately Reduced Left Ventricular Ejection Fraction and a Narrow QRS Duration: Study Rationale and Design

2015 ◽  
Vol 21 (1) ◽  
pp. 16-23 ◽  
Author(s):  
William T. Abraham ◽  
JoAnn Lindenfeld ◽  
Vivek Y. Reddy ◽  
Gerd Hasenfuss ◽  
Karl-Heinz Kuck ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Cardiac Contractility ◽  
Left Ventricular ◽  
Left Ventricular Ejection ◽  
Ventricular Ejection Fraction ◽  
Cardiac Contractility Modulation ◽  
Safety And Efficacy ◽  
Randomized Controlled ◽  
Qrs Duration

A Pilot Randomized Controlled Trial Comparing Levothyroxine to Placebo in Neurologically Deceased Donors

2019 ◽  
Vol 29 (3) ◽  
pp. 261-268
Author(s):  
Anne Julie Frenette ◽  
David Williamson ◽  
Virginie Williams ◽  
Anne-Marie Lagacé ◽  
Emmanuel Charbonney ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Left Ventricular Ejection Fraction ◽  
Ejection Fraction ◽  
Controlled Trial ◽  
Left Ventricular ◽  
Ventricular Ejection ◽  
Left Ventricular Ejection ◽  
Ventricular Ejection Fraction ◽  
Randomized Controlled ◽  
Deceased Donors

Background: Although commonly prescribed, the efficacy of levothyroxine to improve heart function in neurologically deceased donors is unclear. We evaluated the feasibility of a randomized controlled trial to compare levothyroxine to placebo on the variation of left ventricular ejection fraction, in hemodynamically unstable donors. Methods: We conducted a pilot, double-blinded, randomized controlled trial. Deceased donors with reduced left ventricular ejection fraction or needing vasopressors were included. We randomized participants to a 20 μg bolus followed by a 20 μg/h infusion of levothyroxine or an identically appearing placebo. We report the proportion of recruited participants, the time to the administration of the study drug, and protocol violations. Results: Twenty-four participants (N = 24/104; 23.1%) were eligible. Five of them (N = 5/24; 20.8%) were excluded by the attending physician. Four others were not included, due to family refusal for research (n = 2/24;8.3%) and unavailability of research staff (n = 2/24; 8.3%). Fifteen participants were randomized (N = 15/104; 14.4%). Mean time between the echocardiography and the initiation of the drug was 1.73 hours, and14 (93.3%) of 15 of the participants received the drug within 2 hours after the echocardiography. We report no study violation. The study was stopped prematurely because of low recruitment. Conclusion: This pilot trial suggests that the success of a definitive randomized control trial to assess the efficacy of levothyroxine in deceased donors could benefit from a multicenter recruitment and education on the evidence surrounding the pharmacological management of organ donors. The need for consent to research interventions in deceased donors should also be clarified.

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

2018 ◽  
Vol 6 (10) ◽  
pp. 874-883 ◽  
Author(s):  
William T. Abraham ◽  
Karl-Heinz Kuck ◽  
Rochelle L. Goldsmith ◽  
JoAnn Lindenfeld ◽  
Vivek Y. Reddy ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Cardiac Contractility ◽  
Cardiac Contractility Modulation ◽  
Safety And Efficacy ◽  
Randomized Controlled

A periodized model for exercise improves the intra-hospital evolution of patients after myocardial revascularization: a pilot randomized controlled trial

2012 ◽  
Vol 26 (11) ◽  
pp. 982-989 ◽  
Author(s):  
Rafael Michel de Macedo ◽  
José Rocha Faria Neto ◽  
Costantino O Costantini ◽  
Marcia Olandoski ◽  
Dayane Casali ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Postoperative Period ◽  
Controlled Trial ◽  
Myocardial Revascularization ◽  
Left Ventricular ◽  
Left Ventricular Ejection ◽  
Hospital Treatment ◽  
Ventricular Ejection Fraction ◽  
Randomized Controlled ◽  
Pilot Randomized Controlled Trial

Objective: To compare models of the postoperative hospital treatment phase after myocardial revascularization. Design: A pilot randomized controlled trial. Setting: Hospital patients in a hospital setting. Subjects: Thirty-two patients with indications for myocardial revascularization were included between January 2008 and December 2009, with a left ventricular ejection fraction (LVEF) ≥50%, 1-second forced expiratory volume (FEV1) ≥60 and forced vital capacity (FVC) ≥60% of predicted value. Interventions: Patients were randomly placed into two groups: one performed prescribed exercises according to the model proposed by the American College of Sports Medicine (ACSM) and the other according to a periodized model. Main measures: Partial pressure of O2 ( Po2) and arterial O2 saturation ( Sao2), percentage of predicted FVC and total distance on the six-minute walking test (6MWT). Results: Twenty-seven patients were re-evaluated upon release from the hospital (ACSM = 14 and PP = 13). Five patients extubated for more than 6 hours in the postoperative period were excluded from the sample. In the preoperative period the variables Po2, Sao2, % FVC and 6MWT were similar. In the postoperative period, a reduction was observed for all parameters in both groups. Upon comparison of the groups, a difference was observed in Po2 (ACSM = 68.0 ± 4.3 vs. PP = 75.9 ± 4.8 mmHg; P < 0.001), Sao2 (ACSM = 93.5 ± 1.4 vs. PP = 94.8 ± 1.2%; P = 0.018) and 6MWT (ACSM = 339.3 ± 41.7 vs. PP = 393.8 ± 25.7 m; P < 0.001). There was no difference in % FVC. Conclusion: Patients after myocardial revascularization following a periodized model of exercise presented a better intra-hospital evolution when compared to those using the ACSM model.

scholarly journals New Generation Cardiac Contractility Modulation Device—Filling the Gap in Heart Failure Treatment

2019 ◽  
Vol 8 (5) ◽  
pp. 588 ◽  
Author(s):  
Diana Tint ◽  
Roxana Florea ◽  
Sorin Micu
Keyword(s):  
Heart Failure ◽  
Ejection Fraction ◽  
Cardiac Contractility ◽  
Left Ventricular ◽  
Left Ventricular Ejection ◽  
Device Therapy ◽  
Ventricular Ejection Fraction ◽  
Cardiac Contractility Modulation ◽  
New Device ◽  
Wide Range

(1) Background: Heart failure (HF) is a major cause of morbidity and mortality throughout the world. Despite substantial progress in its prevention and treatment, mortality rates remain high. Device therapy for HF mainly includes cardiac resynchronization therapy (CRT) and the use of an implantable cardioverter-defibrillator (ICD). Recently, however, a new device therapy—cardiac contractility modulation (CCM)—became available. (2) Aim: The purpose of this study is to present a first case-series of patients with different clinical patterns of HF with a reduced ejection fraction (HFrEF), supported with the newest generation of CCM devices. (3) Methods and results: Five patients with a left ventricular ejection fraction (LVEF) ≤ 35% and a New York Heart Association (NYHA) class ≥ III were supported with CCM OPTIMIZER® SMART IPGCCMX10 at our clinic. The patients had a median age of 67 ± 8.03 years (47–80) and were all males—four with ischemic etiology dilated cardiomyopathy. In two cases, CCM was added on top of CRT (non-responders), and, in one patient, CCM was delivered during persistent atrial fibrillation (AF). After 6 months of follow-up, the LVEF increased from 25.4 ± 6.8% to 27 ± 9%, and the six-minute walk distance increased from 310 ± 65.1 m to 466 ± 23.6 m. One patient died 47 days after device implantation. (4) Conclusion: CCM therapy provided with the new model OPTIMIZER® SMART IPG CCMX10 is safe, feasible, and applicable to a wide range of patients with HF.

scholarly journals Back to Normal – Normalised Left Ventricular Systolic Function in Dilated Cardiomyopathy after Cardiac Contractility Modulation Therapy

2018 ◽  
Vol 04 (01) ◽  
pp. 25
Author(s):  
Laurens Bon ◽  
Bernhard M Kaess ◽  
Andre Hochgesand ◽  
Albrecht Römer ◽  
Gerd Bürkle ◽  
...  
Keyword(s):  
Dilated Cardiomyopathy ◽  
Systolic Function ◽  
Combined Therapy ◽  
Cardiac Contractility ◽  
Left Ventricular Systolic Function ◽  
Cardiac Resynchronisation Therapy ◽  
Left Ventricular ◽  
Left Ventricular Ejection ◽  
Ventricular Ejection Fraction ◽  
Cardiac Contractility Modulation

We present a clinical case of a patient with dilated cardiomyopathy who neither sufficiently responded to optimal medical therapy nor to cardiac resynchronisation therapy. A cardiac contractility modulation system was implanted and after ~2 years of combined therapy with medication and devices systolic left ventricular ejection fraction returned to near normal values.

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