Heart Failure Clinical Trial
Official title:
A Multicenter, Randomized, Controlled Clinical Study to Evaluate the Effectiveness of Using the Noninvasive Lung Fluid Monitoring System Based on Remote Dielectric Sensing in Guiding the Treatment of Heart Failure
This clinical study is a multicenter, randomized, controlled clinical study to evaluate the effectiveness of using the noninvasive lung fluid monitoring system based on remote dielectric sensing in guiding the treatment of heart failure.
Status | Not yet recruiting |
Enrollment | 1000 |
Est. completion date | December 2026 |
Est. primary completion date | November 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 21 Years to 85 Years |
Eligibility | Inclusion criteria: 1. 21 to 85 years old; 2. Sign an informed consent form; 3. The patient is able to comply with the research protocol; 4. Hospitalized due to acute heart failure. The diagnosis of acute heart failure must simultaneously meet the following criteria: 1) Difficulty breathing during screening due to rest or activity; 2) Chest X-ray or chest CT shows clinical manifestations such as pulmonary congestion, pulmonary edema, and pleural effusion; 3) After the onset of this disease and before screening, any test meets the following criteria: BNP = 400 pg/mL or NT proBNP = 1600 pg/mL in patients with sinus rhythm, BNP = 600 pg/mL or NT proBNP = 2400 pg/mL in patients with atrial fibrillation; 4) Intravenous diuretic treatment is required. Exclusion criteria: 1. Respiratory difficulties caused by non cardiac reasons; 2. Evaluate whether the body condition is not suitable for wearing a ReDS™ non-invasive lung water measuring instrument, including but not limited to: BMI<20 or>39kg/m², height<150cm or>195cm, or flail chest (for patients with BMI between 20-22kg/m², or height between 150-155cm, ReDS™ testing is required to ensure that the body condition is suitable); 3. With a history of heart transplantation or left ventricular assist device implantation, and is still in implantation status; 4. Combination of pulmonary diseases, such as active pneumonia, acute pulmonary embolism, or a history of acute pulmonary embolism within the past 6 months; 5. Severe pulmonary hypertension caused by non left heart disease (pulmonary artery systolic pressure measured by echocardiography = 70mmHg); 6. Simple right heart failure; 7. Patients who undergo thoracotomy or other surgeries or procedures during their intended hospitalization or within one year that affect the wearing of ReDS™; 8. Severe renal insufficiency (eGFR<20ml/min/1.73m²) or dialysis patients; 9. Those with malignant tumors or other serious diseases and an expected survival period of less than 1 year; 10. Pregnant women, pregnancy is defined as the state in which a woman becomes pregnant until the termination of pregnancy; 11. Unable to follow the research instructions or follow the examination, evaluation, and follow-up procedures (including inability to conduct regular follow-up or pulmonary fluid measurement due to the distance from residence to the research center); 12. Any other medical situation that the researcher believes may be a risk to the patient or affect the research results, or any medical situation that the researcher believes is not suitable for the study, including drug or alcohol abuse or mental illness that affects the patient's ability to comply with the protocol or follow-up procedures; 13. Participating in other interventional studies (including patients during washout period). |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Shanghai Zhongshan Hospital |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Total medical costs in the short term (during clinical trials) | Health economics evaluation endpoint | 12 months post-discharge. | |
Other | Short term (clinical trial period) total QALY | Health economics evaluation endpoint | 12 months post-discharge. | |
Other | Incremental Cost Effect Ratio (ICER) | Health economics evaluation endpoint | 12 months post-discharge. | |
Primary | The number of cardiovascular deaths | 12 months post-discharge. | ||
Primary | The number of recurrent heart failure readmissions | A heart failure readmission is defined as a hospitalization due to worsening heart failure or an emergency department visit requiring intravenous diuretic treatment. If a patient in the ReDS-Guided group is suggested to receive intravenous diuretic based on the ReDS™ home visit , it should not be recorded as an event of heart failure (as this is part of the planned follow-up). | 12 months post-discharge. | |
Primary | The change of KCCQ score | 12 months post-discharge. | ||
Secondary | Cardiovascular readmissions | The number of recurrent cardiovascular readmissions. | 12 months post-discharge. | |
Secondary | all-cause mortality | The number of all-cause deaths | 12 months post-discharge. | |
Secondary | First time heart failure readmission | The time from discharge to first heart failure readmission. | 12 months post-discharge. | |
Secondary | All-cause readmissions | The number of recurrent all-cause readmissions. | 12 months post-discharge. | |
Secondary | Cardiovascular mortality | The number of cardiovascular deaths. | 12 months post-discharge. | |
Secondary | All-cause mortality | The number of all-cause deaths. | 12 months post-discharge. | |
Secondary | Change of NT-proBNP | The change of NT-proBNP measurements. | 12 months post-discharge. |
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