Telemonitored Fast Track Medical Sequencing for Heart Failure With Reduced Ejection Fraction
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Safety and feasibility of fast telemonitored sequencing of heart failure medications in HFrEF patients
研究概览
简要总结
Research hypothesis:
Fast telemonitored medical sequencing in patients with heart failure with reduced ejection fraction (HFrEF) is safe and feasible.
Background:
Modern therapy for HFrEF offers a highly effective arsenal of drugs, devices and interventional therapies, yet mortality and morbidity remain high in the cohort. One major problem is that drug therapy introduction and up titration has been very hard to implement in a majority of HFrEF patients. Most previous telemonitoring studies have focused on the continuous monitoring of patients and the monitoring itself has been the main intervention. A potentially more effective way to use telemonitoring in heart failure patients may be to combine the technique with a medical intervention when the patients are most vulnerable to heart failure events. The best therapeutic window lies in the period after newly diagnosed heart failure or right after a recent hospitalization following worsened chronic HFrEF.
Method:
We aim to use telemonitoring for fast sequencing of heart failure drugs for patients with HFrEF.
详细描述
Our hospital and other centra in "Västra Götalandsregionen" has been exploring telemonitoring in a pilot study that started in 2019 and included 100 patients. This study has used an application from Telia called Telia Health Monitoring (THM). Through this application patients may report both objective parameters such as weight, pulse, blood pressure as well as subjective information for example estimation of symptoms and well-being. Overall, this pilot study has reported good safety data and patient satisfaction. In the present study, we intend to use the same application and health care infrastructure as in the pilot study.
Study synopsis
- Primary aim:
The primary aim is to assess effectivness and safety/feasibility of fast telemonitored sequencing of heart failure medications in HFrEF patients. 2. Study population:
Patients (inpatient or outpatient) with confirmed HFrEF who are either newly diagnosed (within 3 month) or hospitalized for worsening heart failure (within 1 month) and in need of medical sequencing are eligible. Different hospitals within "Västra Götalandsregionen" will participate. Participating centres are Sahlgrenska University hospital/Sahlgrenska, Sahlgrenska University hospital/Östra and Skaraborg Hospital Skövde. The aim is also to recruit Södra Älvsborgs hospital as a centre since all these clinics except for Sahlgrenska University hospital/Sahlgrenska have previous experience of the home monitoring equipment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with HFrEF and without contraindications for either of the following drug classes: SGLT2i, BB, RAASi and MRA.
排除标准
- •Estimated glomerular filtration rate (eGFR)<45 ml/min Patients with HFrEF already on treatment with either BB or ACEi/ARNI/ARB and up titrated to >50% of maximal recommended dose.
- •Patients who do not have access to a smartphone or internet connection at home. Patients not able to comprehend the technical aspects of home monitoring or unable to give informed consent.
研究组 & 干预措施
HFrEF patients (diagnosed within 3 months or hospitalized for worsening of HFrEF)
Standardized sequencing of all for main HFrEF drugs: Betablockers, RAASi, SGLT2i, MRA.
All patients will be started on an SGLT2i (Empagliflozin or Dapagliflozin) and a betablocker (Metoprolol, Bisoprolol or Carvedilol) right after study inclusion. In the second week, RAASi will be introduced with either angiotensin converting enzyme inhibitor (ACEi)(Ramipril or Enalapril) or angiotensin receptor neprilisyn inhibitor (ARNI)(Sacubitril/Valsartan). If the patient is intolerant to either of these, an angiotensin receptor blocker (ARB)(Candesartan, Losartan, Valsartan) will be introduced. During the following weeks, both BB and ACEi/ARNI/ARB will be up titrated every second week according to the sequencing algoritm. MRA (Spironolactone, Eplerenone) will be introduced and up titrated in week 3 and 7 respectively. If the patient is already on either BB or ACEi/ARNI/ARB/MRA they will continue with the previous prescription and dose until the titration scheme indicates uptitration.
干预措施: GDMT (Drug)
结局指标
主要结局
Safety and feasibility of fast telemonitored sequencing of heart failure medications in HFrEF patients
时间窗: 180 days
Incidence of treatment-emergent adverse events up to 180 days from start of sequencing.
次要结局
- Proportion of patients reaching full doses or OMT of heart failure drugs with home -monitoring(8 weeks)
- Proportion of patients still on full target dosage or OMT in future follow-up(5 years)
- Changes in levels of NTproBNP during home monitored sequencing(180 days)