挪威将医院内生活方式课程与初级保健随访相结合的心血管预防随机试验：心脏提升研究。

Randomized trial of cardiovascular prevention in Norway combining an in-hospital lifestyle course with primary care follow-up: the Hjerteløftet study.

作者信息

Bergum Hilde, Sandven Irene, Abdelnoor Michael, Anderssen Sigmund Alfred, Grimsmo Jostein, Rivrud Dag Elle, Myhr Nils Erling, Vold Mona Bekken, Stenbakken Cesilie, Lidfors Bengt, Dufseth Laila, Klemsdal Tor Ole

机构信息

Department of rehabilitation and lifestyle medicine, LHL-Hospital Gardermoen, Postboks 103 Jessheimbyen, 2051 Jessheim, Norway.

University of Oslo, Postboks 1078 Blindern, 0316 Oslo, Norway.

出版信息

Eur J Prev Cardiol. 2022 Dec 7;29(17):2252-2263. doi: 10.1093/eurjpc/zwac211.

DOI:10.1093/eurjpc/zwac211

PMID:36124709

Abstract

AIMS

Cardiovascular risk factor control is suboptimal in Europe, including Norway. The present study examined the efficacy of a multimodal primary prevention intervention programme based on the existing Norwegian health care system.

METHODS AND RESULTS

In this open-label randomized controlled trial, adult patients with elevated cardiovascular risk were randomly assigned to an intervention programme including a hospital-based lifestyle course and primary care follow-up or to a control group (CG). The participants were recruited between 2011 and 2015. Primary outcome was change in validated cardiovascular risk scores, national and international (NORRISK, NORRISK 2, Framingham, PROCAM) between baseline and follow-up. Secondary outcomes included major cardiovascular risk factors. After 36 months the NORRISK score was significantly improved in patients assigned to the intervention group (IG) compared to patients assigned to the CG; absolute difference in mean delta score in the IG (n = 305) compared to mean delta score in the CG (n = 296): -0.92, 95% CI: -1.48 to -0.36, P = 0.001. The results for NORRISK 2, Framingham and PROCAM showed similar significant effects. The secondary endpoints including total cholesterol and blood pressure were only minimally, and non-significantly, reduced in the IG, but the proportion of smokers (P = 0.0028) and with metabolic syndrome (P < 0.0001) were significantly reduced. A limited number of cardiovascular events were observed, IG (n = 9), CG (n = 16).

CONCLUSION

In subjects with elevated cardiovascular risk, a newly developed prevention programme, combining a hospital-based lifestyle course and primary care follow-up, significantly reduced cardiovascular risk scores after 36 months. This benefit appeared achievable primarily through improvements in metabolic syndrome characteristics and smoking habits.The study protocol was registered in ClinicalTrials.gov (NCT01741428).

摘要

目的

在欧洲，包括挪威，心血管危险因素控制并不理想。本研究基于挪威现有的医疗保健系统，检验了多模式一级预防干预项目的效果。

方法与结果

在这项开放标签随机对照试验中，心血管风险升高的成年患者被随机分配至一个干预项目组（包括以医院为基础的生活方式课程和初级保健随访）或对照组（CG）。参与者于2011年至2015年招募。主要结局是基线和随访之间经过验证的心血管风险评分（国内和国际的，NORRISK、NORRISK 2、弗明汉、PROCAM）的变化。次要结局包括主要心血管危险因素。36个月后，与分配至CG组的患者相比，分配至干预组（IG）的患者的NORRISK评分显著改善；IG组（n = 305）的平均变化评分与CG组（n = 296）的平均变化评分的绝对差值：-0.92，95%置信区间：-1.48至-（此处原文有误，应为-）0.36，P = 0.001。NORRISK 2、弗明汉和PROCAM的结果显示出类似的显著效果。包括总胆固醇和血压在内的次要终点在IG组仅略有降低且无显著差异，但吸烟者比例（P = 0.0028）和患有代谢综合征的比例（P < 0.0001）显著降低。观察到的心血管事件数量有限，IG组（n = 9），CG组（n = 16）。