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NCT05642650
Novel Wearable Device for Heart Failure Management
Conditions: Heart Failure
Sex: All
Ages: 18 Years – N/A
Phase: NA
Enrollment: 108
Sponsor: China-Japan Friendship Hospital
Summary
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.
Eligibility Criteria
Inclusion Criteria:Diagnosis of HF ≥ 3 monthsDiagnosis of NYHA Class III HFSubjects with age ≥ 18 yearsAt least 1 HF hospitalization within 12 months prior to enrollmentSubjects with elevated ambulatory levels of BNP/NT-proBNPExclusion 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 areaSubjects with active uncontrolled infectionsSubjects with eGFR < 25 mL/min/1.73m2Pregnant women, or women likely to undergo pregnancySubjects with life expectancy less than 6 months
Source: ClinicalTrials.gov (NCT05642650). StuddyBuddy aggregates publicly available trial information.