25 research outputs found
A prospective comparison of alginate-hydrogel with standard medical therapy to determine impact on functional capacity and clinical outcomes in patients with advanced heart failure (AUGMENT-HF trial)
Aims AUGMENT-HF was an international, multi-centre, prospective, randomized, controlled trial to evaluate the benefits and safety of a novel method of left ventricular (LV) modification with alginate-hydrogel. Methods: Alginate-hydrogel is an inert permanent implant that is directly injected into LV heart muscle and serves as a prosthetic scaffold to modify the shape and size of the dilated LV. Patients with advanced chronic heart failure (HF) were randomized (1 : 1) to alginate-hydrogel (n = 40) in combination with standard medical therapy or standard medical therapy alone (Control, n = 38). The primary endpoint of AUGMENT-HF was the change in peak VO2 from baseline to 6 months. Secondary endpoints included changes in 6-min walk test (6MWT) distance and New York Heart Association (NYHA) functional class, as well as assessments of procedural safety. Results: Enrolled patients were 63 ± 10 years old, 74% in NYHA functional class III, had a LV ejection fraction of 26 ± 5% and a mean peak VO2 of 12.2 ± 1.8 mL/kg/min. Thirty-five patients were successfully treated with alginate-hydrogel injections through a limited left thoracotomy approach without device-related complications; the 30-day surgical mortality was 8.6% (3 deaths). Alginate-hydrogel treatment was associated with improved peak VO2 at 6 months—treatment effect vs. Control: +1.24 mL/kg/min (95% confidence interval 0.26–2.23, P = 0.014). Also 6MWT distance and NYHA functional class improved in alginate-hydrogel-treated patients vs. Control (both P < 0.001). Conclusion: Alginate-hydrogel in addition to standard medical therapy for patients with advanced chronic HF was more effective than standard medical therapy alone for improving exercise capacity and symptoms. The results of AUGMENT-HF provide proof of concept for a pivotal trial. Trial Registration Number NCT01311791
A prospective comparison of alginate-hydrogel with standard medical therapy to determine impact on functional capacity and clinical outcomes in patients with advanced heart failure (AUGMENT-HF trial)
Aims AUGMENT-HF was an international, multi-centre, prospective,
randomized, controlled trial to evaluate the benefits and safety of a
novel method of left ventricular (LV) modification with
alginate-hydrogel.
Methods Alginate-hydrogel is an inert permanent implant that is directly
injected into LV heart muscle and serves as a prosthetic scaffold to
modify the shape and size of the dilated LV. Patients with advanced
chronic heart failure (HF) were randomized (1 : 1) to alginate-hydrogel
(n = 40) in combination with standard medical therapy or standard
medical therapy alone (Control, n = 38). The primary endpoint of
AUGMENT-HF was the change in peak VO2 from baseline to 6 months.
Secondary endpoints included changes in 6-min walk test (6MWT) distance
and New York Heart Association (NYHA) functional class, as well as
assessments of procedural safety.
Results Enrolled patients were 63 +/- 10 years old, 74% in NYHA
functional class III, had a LV ejection fraction of 26 +/- 5% and a
mean peak VO2 of 12.2 +/- 1.8 mL/kg/min. Thirty-five patients were
successfully treated with alginate-hydrogel injections through a limited
left thoracotomy approach without device-related complications; the
30-day surgical mortality was 8.6% (3 deaths). Alginate-hydrogel
treatment was associated with improved peak VO2 at 6 months-treatment
effect vs. Control: +1.24 mL/kg/min (95% confidence interval 0.26-2.23,
P = 0.014). Also 6MWT distance and NYHA functional class improved in
alginate-hydrogel-treated patients vs. Control (both P < 0.001).
Conclusion Alginate-hydrogel in addition to standard medical therapy for
patients with advanced chronic HF was more effective than standard
medical therapy alone for improving exercise capacity and symptoms. The
results of AUGMENT-HF provide proof of concept for a pivotal trial
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Selective Inhibition of Nuclear Export With Oral Selinexor for Treatment of Relapsed or Refractory Multiple Myeloma
Purpose Selinexor, a first-in-class, oral, selective exportin 1 (XPO1) inhibitor, induces apoptosis in cancer cells through nuclear retention of tumor suppressor proteins and the glucocorticoid receptor, along with inhibition of translation of oncoprotein mRNAs. We studied selinexor in combination with low-dose dexamethasone in patients with multiple myeloma refractory to the most active available agents. Patients and Methods This phase II trial evaluated selinexor 80 mg and dexamethasone 20 mg, both orally and twice weekly, in patients with myeloma refractory to bortezomib, carfilzomib, lenalidomide, and pomalidomide (quad-refractory disease), with a subset also refractory to an anti-CD38 antibody (penta-refractory disease). The primary end point was overall response rate (ORR). Results Of 79 patients, 48 had quad-refractory and 31 had penta-refractory myeloma. Patients had received a median of seven prior regimens. The ORR was 21% and was similar for patients with quad-refractory (21%) and penta-refractory (20%) disease. Among patients with high-risk cytogenetics, including t(4;14), t(14;16), and del(17p), the ORR was 35% (six of 17 patients). The median duration of response was 5 months, and 65% of responding patients were alive at 12 months. The most common grade ≥ 3 adverse events were thrombocytopenia (59%), anemia (28%), neutropenia (23%), hyponatremia (22%), leukopenia (15%), and fatigue (15%). Dose interruptions for adverse events occurred in 41 patients (52%), dose reductions occurred in 29 patients (37%), and treatment discontinuation occurred in 14 patients (18%). Conclusion The combination of selinexor and dexamethasone has an ORR of 21% in patients with heavily pretreated, refractory myeloma with limited therapeutic options