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

NCT06102031 | Not Yet Recruiting DMC

• 1 other identifier: V2.0
• Study Type: interventional
• Target: 1,000
• Locations: 0 countries
• Sites: N/A

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 guiding the treatment of heart failure.

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (7)

• Cardiovascular readmissions

  12 months post-discharge.

• all-cause mortality

  12 months post-discharge.

• First time heart failure readmission

  12 months post-discharge.

• All-cause readmissions

  12 months post-discharge.

• Cardiovascular mortality

  12 months post-discharge.

Other Outcomes (3)

• Total medical costs in the short term (during clinical trials)

  12 months post-discharge.

• Short term (clinical trial period) total QALY

  12 months post-discharge.

• Incremental Cost Effect Ratio (ICER)

  12 months post-discharge.

Study Arms (2)

Randomized Arm-Treatment Group

EXPERIMENTAL

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

Randomized Arm-Control Group

SHAM COMPARATOR

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

Interventions

ReDS-Guided DEVICE

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.

Randomized Arm-Treatment Group

Usual care OTHER

ReDS measurements will not be shared with the treating clinicians and the subjects, diuretic treatment will only be guided using standard clinical care.

Randomized Arm-Control Group

Eligibility Criteria

• Age: 21 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• \) 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Central Study Contacts

Xiaotong Cui

CONTACT

13681959319; cui.xiaotong@zs-hospital.sh.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2023
• First Posted: October 26, 2023
• Study Start: November 1, 2023
• Primary Completion: November 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: October 26, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share