Clinical Study on the Noninvasive Lung Fluid Monitoring System in Guiding the Treatment of Heart Failure

Prior treatment

• Participating in other interventional studies (including patients during washout period).

Other illness

• Respiratory difficulties caused by non cardiac reasons;
• 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);
• With a history of heart transplantation or left ventricular assist device implantation, and is still in implantation status;
• Combination of pulmonary diseases, such as active pneumonia, acute pulmonary embolism, or a history of acute pulmonary embolism within the past 6 months;
• Severe pulmonary hypertension caused by non left heart disease (pulmonary artery systolic pressure measured by echocardiography ≥ 70mmHg);
• Simple right heart failure;
• Those with malignant tumors or other serious diseases and an expected survival period of less than 1 year;
• 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;

Lab values

• Severe renal insufficiency (eGFR\<20ml/min/1.73m²) or dialysis patients;

Other

• Patients who undergo thoracotomy or other surgeries or procedures during their intended hospitalization or within one year that affect the wearing of ReDS™;
• Pregnant women, pregnancy is defined as the state in which a woman becomes pregnant until the termination of pregnancy;
• 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);

• 21 to 85 years old;
• Sign an informed consent form;
• The patient is able to comply with the research protocol;
• 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.