Daily Ambulatory Remote Monitoring System For Post-Dischage Management Of ADHF

NCT03072693 | Unknown DMC

• 1 other identifier: CARDIAC_HF_1
• Study Type: interventional
• Target: 876
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Despite the advances in pharmacological management of heart failure (HF), the associated mortality and re-hospitalization for HF remain poor. This is at least partly due to suboptimal early discharge care, delayed detection of HF complications, and underutilization and under-dosing of evidence-based HF medications. Mobile technology has revolutionized inter-personal communication allowing instantaneous, multi-directional, and massive data transfer. Nonetheless the potential of these enhanced communications have not been fully explored in the management of patients with HF. Objective: To explore the potential of state-of-the-art mobile technology for home-based remote HF management in order to reduce HF mortality and HF re-hospitalization. Study Design: This will be a multicenter, randomized controlled clinical trial in patients with HF and reduced left ventricular ejection fraction (LVEF) who are discharged from hospital following an episode of acutely decompensated HF. The clinical effectiveness of a physician-directed patient self-management strategy based on remotely collected physiological data obtained from home-based and wearable devices will be compared with two control groups who will receive the home-based remote HF management system without activation or routine therapy. In the interventional arm, there will be three modes of home-based HF management: (1) Early discharge mode to optimize volume status; (2) Drug escalation mode to ensure the utilization of evidence-based medications at the maximum tolerated dose; and (3) Maintenance mode to ensure medication compliance and early detection of complications such as acutely decompensated HF and atrial fibrillation. The trial will enroll up to 876 patients with LVEF \<40% who are discharged from hospital after an episode of acutely decompensated HF. Randomization to the intervention group or control groups will be in a 1:1:1 ratio with follow-up for 1 year. The primary outcome will be a composite of cardiovascular death and HF hospitalization within 1 year. Summary: DAVID-HF will provide essential information about the role of home-based, remote heart failure monitoring that will incorporate instantaneous physician-directed patient-self management in the long-term management of HF patients.

Conditions

Heart Failure With Reduced Ejection Fraction

Outcome Measures

Primary Outcomes (1)

• Composite Primary Endpoints

  composite of re-hospitalization for acute decompensated HF and/or mortality

  12 months

Secondary Outcomes (6)

• 1-year mortality

  12 months

• 1-year heart failure rehospitalization

  12 months

• Visual analog symptom score

  Continuously for 12 months

• 6-minute walking distance

  intermittently for 12 months

• Utilization of evidence-based anti-heart failure medications

  12 months

Study Arms (2)

Group 1

ACTIVE COMPARATOR

Home-based remote heart failure management

Procedure: Home-based remote heart failure management

Group 2

PLACEBO COMPARATOR

Home-based physiological parameter recording only

Procedure: Home-based physiological parameter recording only

Interventions

Home-based remote heart failure management PROCEDURE

For patients randomized to Group 1, the home-based remote heart failure management system will be connected via the internet for active intervention. In Group 2 patients, the system will not be activated although all data will continue to be stored and reviewed at clinic visits. For patients in Group 1, clinically-assigned targets and alert thresholds of individual physiological parameters including blood pressure, pulse rate, and body weight will be decided before discharge and at entry into the three management modes. Site investigators will review individual patient physiological parameters upon clinic visits, and treatment can be initiated through instant communication (electronic communication and/or phone).

Group 1

Home-based physiological parameter recording only PROCEDURE

For patients randomized to Group 2, the home-based remote heart failure management system will continuously record and store patients information to be reviewed at clinic visits but not connected to internet. Site investigators will review individual patient physiological parameters upon clinic visits, and no treatment will be initiated through instant communication.

Group 2

Eligibility Criteria

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

You may qualify if:

• Age ≥ 18 years
• Recently discharged from hospital for acutely decompensated HF (within 2 weeks) requiring intravenous diuretic therapy.
• Left ventricular ejection fraction \<40%
• Voluntarily agrees to participate by providing written informed consent

You may not qualify if:

• Acute coronary syndrome within 4 weeks
• Complex congenital heart disease
• Significant valvular stenosis
• Left ventricular assist device
• Planned cardiac intervention including revascularization, cardiac resynchronization, and valvular surgery
• Listed for heart transplant
• Renal impairment with serum creatinine ≥250 μmol/L or on renal replacement therapy
• Inability or refusal to provide inform consent
• Lack of skills in operating simple electronic devices
• Unavailability of a mobile network service in the place of residence

Sponsors & Collaborators

• The University of Hong Kong: lead
• Chinese University of Hong Kong: collaborator
• Novartis Pharmaceuticals: collaborator
• Biofourmis Singapore Pte Ltd.: collaborator

Study Sites (1)

The University of Hong Kong, Queen Mary Hospital

Pokfulam, Hong Kong Island, Hong Kong

Location

Study Officials

• Chung-Wah David Siu, Professor

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Remote monitoring device given to subjects for daily monitoring to vital signs, activities and discomfort. Medication to be adjusted by investigators according to the recorded parameters and patients' condition.

Study Record Dates

• First Submitted: March 2, 2017
• First Posted: March 7, 2017
• Study Start: November 2, 2020
• Primary Completion: April 30, 2023
• Study Completion: April 30, 2023
• Last Updated: August 9, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)