American heart journal
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American heart journal · Feb 2014
Randomized Controlled Trial Multicenter Study Comparative StudyTRIple pill vs Usual care Management for Patients with mild-to-moderate Hypertension (TRIUMPH): Study protocol.
Hypertension management strategies have traditionally focused on "tailored therapy" and "stepped-care" approaches. These tend to be costly and time consuming and often fail to achieve adequate blood pressure (BP) control. The TRIUMPH study aims to investigate the effectiveness, cost-effectiveness, and acceptability of early use of a 3-in-1 BP-lowering pill ("Triple Pill") compared with usual care for the management of hypertension. ⋯ This study will determine whether early use of a low-dose triple combination therapy has the potential to address some of the challenges in hypertension control through earlier achievement of BP control, better adherence, and fewer adverse effects, in the context of less intensive clinical follow-up.
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American heart journal · Feb 2014
Randomized Controlled Trial Multicenter Study Comparative StudyEPITOME-2: An open-label study assessing the transition to a new formulation of intravenous epoprostenol in patients with pulmonary arterial hypertension.
Continuous infusion of epoprostenol is the treatment of choice in patients with pulmonary arterial hypertension in functional classes III to IV. However, this treatment's limitations include instability at room temperature. A new epoprostenol formulation offers improved storage conditions and patient convenience. ⋯ Transition from epoprostenol with glycine and mannitol excipients to epoprostenol with arginine and sucrose excipients did not affect treatment efficacy, raised no new safety or tolerability concerns, and provided patients with an increased sense of treatment convenience.
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American heart journal · Feb 2014
Randomized Controlled Trial Multicenter Study Comparative StudyTwo formulations of epoprostenol sodium in the treatment of pulmonary arterial hypertension: EPITOME-1 (epoprostenol for injection in pulmonary arterial hypertension), a phase IV, open-label, randomized study.
Epoprostenol sodium with arginine-mannitol excipients (epoprostenol AM; Veletri [Actelion Pharmaceuticals Ltd, Allschwil, Switzerland]) and epoprostenol sodium with glycine-mannitol excipients (epoprostenol GM; Flolan [GlaxoSmithKline, Triangle Park, NC]) are intravenous treatments for pulmonary arterial hypertension (PAH). Epoprostenol AM contains different inactive excipients, resulting in greater stability at room temperature compared with epoprostenol GM. ⋯ In this randomized clinical study of epoprostenol AM in PAH, use of this novel preparation with greater room temperature stability was well tolerated.
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American heart journal · Feb 2014
Randomized Controlled Trial Multicenter Study Comparative StudyErectile dysfunction in the cardiology practice-a patients' perspective.
Erectile dysfunction (ED) is an independent risk factor for cardiovascular events sharing mutual risk factors with coronary artery disease. Several guidelines for the management of ED in cardiovascular disease have been proposed, recommending cardiologists to routinely inquire about erectile function. However, males' specific needs and wishes regarding sexual health care in cardiology are unknown. We sought to identify male patients' view concerning possible improvements in sexual health care and preferred forms of sexual counseling in the cardiology practice. ⋯ Erectile dysfunction is highly prevalent in patients with a variety of cardiovascular diagnosis and care for sexual function is mandatory. Patients indicated that above consultation with the cardiologist, both consultation with a specialized nurse and written information would be helpful.
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American heart journal · Feb 2014
Randomized Controlled Trial Comparative StudyAmsterdam Investigator-initiateD Absorb strategy all-comers trial (AIDA trial): a clinical evaluation comparing the efficacy and performance of ABSORB everolimus-eluting bioresorbable vascular scaffold strategy vs the XIENCE family (XIENCE PRIME or XIENCE Xpedition) everolimus-eluting coronary stent strategy in the treatment of coronary lesions in consecutive all-comers: rationale and study design.
The Absorb everolimus-eluting bioresorbable vascular scaffold (AbsorbBVS) is a completely resorbable device engineered to overcome the limitations of permanent metallic stents, providing temporary scaffolding and antiproliferative drug delivery for the treatment of obstructive coronary artery disease. ⋯ The AIDA trial will provide the first randomized direct comparison between the everolimus-eluting bioresorbable vascular scaffold and the everolimus-eluting metallic stent in contemporary percutaneous coronary intervention practice.