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

Fudan University

Status: Not yet enrolling

Conditions: Heart Failure

Treatments: Other: Usual care; Device: ReDS-Guided

Study type: Interventional

Funder types: Other

Identifiers

NCT06102031

V2.0

Details and patient eligibility

About

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.

Full 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 routine treatment.

The study is divided into two stages

1. Stage 1 is the observation stage for selected heart failure patients during the hospitalization period (from enrollment to discharge). During this stage, patients complete screening, enrollment, and randomization within 72 hours after admission, and are randomly assigned to the experimental group or control group in a 1:1 ratio. All patients receive ReDS™ measurement on the day after randomization, but without using measurement data to intervene the treatment during hospitalization. The randomization of patients and the measurement data remained blind to the treatment clinicians.
2. Stage 2 is the intervention stage, which lasts for 12 months. Firstly, two groups of patients receive ReDS™ measurement on the day of planned discharge. For the control group, this measurement data will still not used as a reference for discharge decision, and remains blind to clinicians; For the experimental group, treatment clinicians will give interventional therapy based on the ReDS™ results.

Approximately 1000 patients will be randomly assigned to the experimental group or control group in a 1:1 ratio, with 500 patients in each group.

Primary/secondary endpoint analysis: will be based on all randomized patients (i.e. ITT population). The Kaplan Meier method was used to estimate the median TTF for each study group. Using the Cox regression model, calculate the regression coefficients or HR values, and their 95% CI. Using forest maps (including HR estimates) to evaluate the homogeneity of intervention effects in important subgroups. The predetermined subgroup analysis will provide additional detailed information in SAP. The hypothesis of primary and secondary endpoints will be formally tested using SAS and Stata statistical software at a unilateral significance level of 0.025.

Safety analysis: Randomized safety analysis based on the safety analysis population.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 21 to 85 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,000 participants in 2 patient groups

Randomized Arm-Treatment Group

Experimental group

Description:

Management of subjects based on lung fluid content derived from the ReDS™ system. All subjects will receive ReDS™ test during hospitalization, at discharge, several home visits and 3 times outpatient follow-up. For home visits frequency, ReDS™ tests will be performed every 7 days within 1 month of discharge; at the 2nd to 3rd month, ReDS™ test wil be performed every 15 days. Then ReDS™ test will be performed every 30 days from 4th to 12th months. Patients will be followed up in outpatient at 3 months, 6 months, and 12 months after discharge.

Treatment:

Device: ReDS-Guided

Randomized Arm-Control Group

Sham Comparator group

Description:

Management of subjects based on standard of care(signs, symptoms, weight, biomarkers, etc.) without lung fluid content information. All subjects will receive ReDS™ test during hospitalization, at discharge, several home visits and 3 times outpatient follow-up. For home visits frequency, ReDS™ tests will be performed every 7 days within 1 month of discharge; at the 2nd to 3rd month, ReDS™ test wil be performed every 15 days. Then ReDS™ test will be performed every 30 days from 4th to 12th months. Patients will be followed up in outpatient at 3 months, 6 months, and 12 months after discharge.

Treatment:

Other: Usual care