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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Heart Failure
• Intervention / Treatment: Device: ReDS-Guided; Other: Usual care

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 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.

• Study Type: Interventional
• Enrollment (Estimated): 1000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Xiaotong Cui; Phone Number: 13681959319; Email: cui.xiaotong@zs-hospital.sh.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Randomized Arm-Treatment Group; 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.	Device: ReDS-Guided; ReDS™ measurements will be shared with the treating clinicians to guide diuretic treatment when discharge, home visit and outpatient follow-up, but blinded to the subjects. At discharge:① If the ReDS™ reading <36%, discharge as planned; ②ReDS™ reading ≥36%, increase the oral diuretic dose, discharge as planned. When home visit and outpatient follow-up: ① If the ReDS™ reading <20%, hold diuretics; ② If the ReDS™ reading was between 21-35%, maintain current diuretic dose and optimize GDMT. If the ReDS™ change ≥ 6% from the previous one, increase diuretic dose and optimize the GDMT; ③ If the ReDS™ reading was between 36-45%, increase diuretics and optimize the GDMT, then repeat ReDS™ test after 1 week(home visit); ④ If the ReDS™ reading was above 46%, consider intravenous diuretic therapy, and repeat ReDS™ test after 1 week(home visit) or hospitalization.
Sham Comparator: Randomized Arm-Control Group; 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.	Other: Usual care; ReDS measurements will not be shared with the treating clinicians and the subjects, diuretic treatment will only be guided using standard clinical care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The number of cardiovascular deaths		12 months post-discharge.
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.
The change of KCCQ score		12 months post-discharge.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cardiovascular readmissions	The number of recurrent cardiovascular readmissions.	12 months post-discharge.
all-cause mortality	The number of all-cause deaths	12 months post-discharge.
First time heart failure readmission	The time from discharge to first heart failure readmission.	12 months post-discharge.
All-cause readmissions	The number of recurrent all-cause readmissions.	12 months post-discharge.
Cardiovascular mortality	The number of cardiovascular deaths.	12 months post-discharge.
All-cause mortality	The number of all-cause deaths.	12 months post-discharge.
Change of NT-proBNP	The change of NT-proBNP measurements.	12 months post-discharge.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total medical costs in the short term (during clinical trials)	Health economics evaluation endpoint	12 months post-discharge.
Short term (clinical trial period) total QALY	Health economics evaluation endpoint	12 months post-discharge.
Incremental Cost Effect Ratio (ICER)	Health economics evaluation endpoint	12 months post-discharge.

Collaborators and Investigators

• Sponsor: Shanghai Zhongshan Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): November 1, 2023
• Primary Completion (Estimated): November 1, 2025
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: October 11, 2023
• First Submitted That Met QC Criteria: October 25, 2023
• First Posted (Actual): October 26, 2023

Study Record Updates

• Last Update Posted (Actual): October 26, 2023
• Last Update Submitted That Met QC Criteria: October 25, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: V2.0

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No