Mayo Heart Failure Regional Clinical Center

描述（由申请人提供）： 本提案代表马约心力衰竭项目申请参加心脏 失败（HF）临床研究网络（HF-CRN），其目标是加速HF诊断和管理的研究，以便通过评估新的治疗策略来改善结局。在本申请中，我们记录了我们参与HF-CRN的资格以及我们与其他中心合作的意愿，以便通过在HF-CRN内进行小型多中心试验，将HF研究中的发现快速转化为HF治疗的进展。为了支持这一申请，我们提出了两个方案，测试新的治疗方法，为重要的HF人群，这是基于我们以前的实验室为基础的，面向患者和人口为基础的研究，并需要一个多中心，学术研究网络完成。我们还将提供临床研究技能发展核心的申请，以促进未来临床HF研究者的培训。将讨论四个具体目标。 具体目标1。记录马约HF项目拥有临床资源和研究支持基础设施以及临床、转化和基础研究专业知识，以协助开发HF-CRN并确保积极参与HF-CRN。 具体目标2。方案1：一项慢性皮下注射（SQ）脑钠肽（BNP）治疗射血分数正常的临床心力衰竭（以下称为舒张性心力衰竭，DHF）患者的随机、双盲、前瞻性治疗试验。假设与标准治疗相比，慢性SQ BNP治疗将通过改变DHF患者临床HF特征的关键病理生理学领域来改善临床状态。 具体目标3。方案2：一项在急性失代偿性HF（ADHF）治疗期间肾功能恶化（心肾综合征，CRS）高风险患者中比较低剂量脑利钠肽（BNP）输注（不伴或伴磷酸二酯酶V抑制剂（西地那非））与标准治疗的随机、安慰剂对照研究。假设为：1）与标准治疗相比，低剂量BNP将改善CRS高风险ADHF患者的肾功能; 2）与标准治疗或低剂量BNP单独治疗相比，低剂量BNP和磷酸二酯酶V抑制剂联合治疗将改善CRS高风险ADHF患者的肾功能。 具体目标4。建立临床HF研究技能发展核心目标是培养未来的临床HF研究人员，促进他们获得独立地位的能力。(End摘要）

DESCRIPTION (provided by applicant): This proposal represents the Mayo Heart Failure Program's application to participate in the Heart Failure (HF) Clinical Research Network (HF-CRN) whose goal is to accelerate research in the diagnosis and management of HF in order to improve outcomes through evaluation of novel therapeutic strategies. In this application, we document our qualifications to participate in the HF-CRN and our willingness to collaborate with other centers in order to rapidly translate discoveries in HF research to advances in the treatment of HF by performing small multi-center trials within the HF-CRN. In support of this application, we present two protocols that test novel therapeutic approaches for important HF populations which are based on our previous laboratory based, patient oriented and population based studies and require a multi-center, academic research network for completion. We will also provide an application for a Clinical Research Skills Development Core to facilitate the training of future clinical HF investigators. Four specific aims will be addressed. Specific Aim 1. Document that the Mayo HF Program has the clinical resources and research support infrastructure as well as the clinical, translational and basic research expertise to assist in the development of and to insure active collaborative participation in the HF-CRN. Specific Aim 2. Protocol 1: A randomized, double-blind, prospective treatment trial of chronic subcutaneous (SQ) brain natriuretic peptide (BNP) in patients with clinical heart failure and preserved ejection fraction (referred to subsequently as diastolic heart failure, DHF). The hypothesis is that compared to standard therapy, therapy with chronic SQ BNP will improve clinical status by altering the key pathophysiological domains that characterize clinical HF in patients with DHF. Specific Aim 3. Protocol 2: A randomized, placebo controlled study of low dose brain natriuretic peptide (BNP) infusion without or with concomitant phosphodiesterase V inhibition (sildenafil) versus standard therapy in patients at high risk for worsening renal function (cardiorenal syndrome, CRS) during treatment of acute decompensated HF (ADHF). The hypotheses are 1) compared to standard therapy, low dose BNP will improve renal function in patients with ADHF at high risk for the CRS; and 2) compared to standard therapy or low dose BNP alone, combination therapy with low dose BNP and phosphodiesterase V inhibition will improve renal function in patients with ADHF at high risk for the CRS. Specific Aim 4. Establish a Clinical HF Research Skills Development Core The objective is to train future investigators in clinical HF research facilitating their ability to attain independent status. (End of Abstract)