심부전 관리를 위한 새로운 웨어러블 장치
심부전의 비침습적 관리에서 특허받은 센싱 기술을 기반으로 한 새로운 웨어러블 장치의 임상 중개 연구
Heart failure (HF) is a major cardiovascular disease with high readmission and mortality rate. A wearable device that could remotely monitor and detect the worsening HF early before the symptoms appear will help reduce HF readmissions effectively. The purpose of the current study is to examine the efficiency of a novel wearable device based on flexible strain sensor comparing to the clinical 'gold standard,' and then transform it into a clinical application.
연구 개요
상세 설명
The prospective cohort study aims to examine the efficiency of a novel wearable device based on a flexible strain sensor to improve the outcomes of patients with HF compared to the standard-of-care without wearable device monitoring.
The primary and secondary endpoints will be examined in subgroups determined by baseline variables reflecting demography,NYHA functional class,left ventricular ejection fraction,natriuretic peptide,additional co-morbidities,and others.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Di Sun, Dr.
- 전화번호: 010-84206809
- 이메일: sundi0929@163.com
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Diagnosis of HF ≥ 3 months
- Diagnosis of NYHA Class III HF
- Subjects with age ≥ 18 years
- At least 1 HF hospitalization within 12 months prior to enrollment
- Subjects with elevated ambulatory levels of BNP/NT-proBNP
Exclusion Criteria:
- Subjects unable to cooperate to complete the trial.
- Subjects with severe arrhythmia.
- Subjects with cardiac shock.
- Subjects with acute myocardial infarction.
- Subjects with local skin infections and injuries in the jugular vein area
- Subjects with active uncontrolled infections
- Subjects with eGFR < 25 mL/min/1.73m2
- Pregnant women, or women likely to undergo pregnancy
- Subjects with life expectancy less than 6 months
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 상영
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Novel wearable device strategy group
Patients with a novel wearable device for monitoring and uploading data daily to collect monitoring data such as jugular vein pressure and exercise steps. |
Patients with a novel wearable device for monitoring and uploading data daily to collect monitoring data such as jugular vein pressure and exercise steps after discharge. |
|
간섭 없음: Control group
Patients receive a standard of care for heart failure without a wearable device. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Rate of Hospital Readmissions for Heart Failure
기간: Up to 6 months
|
Total hospitalizations for heart failure will be monitored via follow-up. |
Up to 6 months
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Concordance of the Jugular Vein Pressure with the RHC Measurement
기간: Up to 6 months
|
Accuracy of jugular vein pressure measurements by the novel wearable device compared to right heart catheterization. |
Up to 6 months
|
|
Change From Baseline N-terminal Pro-brain Natriuretic Peptide(NT-proBNP) or Brain Natriuretic Peptide(BNP)
기간: Up to 6 months
|
Change from baseline to 6 months in N-terminal pro-brain natriuretic peptide (NT-proBNP) or Brain Natriuretic Peptide(BNP). NT-proBNP/BNP level will be measured using commercial kits system during the follow-up period. Change from baseline was defined as the value of NT-proBNP/BNP at 6 months minus the baseline value. Baseline value was defined as the mean of all available measurements from the screening visit. |
Up to 6 months
|
|
Change in Exercise Capacity as Measured by the 6-Minutes-Walking-Test (6MWT) Distance.
기간: Up to 6 months
|
Change from baseline to 6 months in exercise capacity as measured by the distance walked in 6 minutes in standardised conditions. |
Up to 6 months
|
|
Compliance Percentage of Patients
기간: Up to 6 months
|
Patient adherence to daily measurement and transmission of sensor readings will be recorded. |
Up to 6 months
|
|
Change in Quality of Life
기간: Up to 6 months
|
Quality of life will be measured with the Kansas City Cardiomyopathy Questionnaire (KCCQ) answered by the patients directly on a patient application.KCCQ is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. The KCCQ total symptom score incorporates the symptom domains into a single score. Scores are transformed to a range of 0-100, in which higher scores reflect better health status. |
Up to 6 months
|
|
Change in New York Heart Association (NYHA) functional class.
기간: Up to 6 months
|
NYHA class will be evaluated according to the patients' clinical characteristics during the follow-up.NYHA Functional Classification places patients in one of four categories based on how much they are limited during physical activity; Class I being best and Class IV being the worst functional class. Class I has no limitation to physical activity, Class II has slight limitation to physical activity, Class III has marked limitation of physical activity, and Class IV is unable to carry out any physical activity without severe discomfort. |
Up to 6 months
|
|
Freedom From a Device/System-related Complication
기간: Up to 6 months
|
Device/System-related Complications refer to adverse events such as device failure and allergy. |
Up to 6 months
|
기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Subjects Included the Endpoint of Cardiovascular Mortality
기간: Up to 6 months
|
Rate of cardiovascular mortality will be monitored via follow-up. |
Up to 6 months
|
|
Subjects Included the Endpoint of all-cause Mortality
기간: Up to 6 months
|
Rate of all-cause mortality will be monitored via follow-up. |
Up to 6 months
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- 2022-NHLHCRF-YXHZ-01
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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