Status:
NOT_YET_RECRUITING
Clinical Study on the Noninvasive Lung Fluid Monitoring System in Guiding the Treatment of Heart Failure
Lead Sponsor:
Shanghai Zhongshan Hospital
Conditions:
Heart Failure
Eligibility:
All Genders
21-85 years
Phase:
NA
Brief Summary
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 gu...
Detailed Description
The main purpose of this study is to explore and validate the effectiveness by using ReDS™ to guide the treatment of heart failure patients during hospitalization and after discharge based on current ...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- 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.
- Exclusion criteria:
- 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;
- Patients who undergo thoracotomy or other surgeries or procedures during their intended hospitalization or within one year that affect the wearing of ReDS™;
- Severe renal insufficiency (eGFR\<20ml/min/1.73m²) or dialysis patients;
- Those with malignant tumors or other serious diseases and an expected survival period of less than 1 year;
- 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);
- 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;
- Participating in other interventional studies (including patients during washout period).
Exclusion
Key Trial Info
Start Date :
November 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
1000 Patients enrolled
Trial Details
Trial ID
NCT06102031
Start Date
November 1 2023
End Date
December 1 2026
Last Update
October 26 2023
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