Daily Ambulatory Remote Monitoring System For Post-Dischage Management Of ADHF (DAVID-HF)
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|ClinicalTrials.gov Identifier: NCT03072693|
Recruitment Status : Not yet recruiting
First Posted : March 7, 2017
Last Update Posted : August 13, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Heart Failure With Reduced Ejection Fraction||Procedure: Home-based remote heart failure management Procedure: Home-based physiological parameter recording only||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||876 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Daily Ambulatory Remote Monitoring System Vs Conventional Therapy For The Post-Dischage Management Of Acute Decompensated Heart Failure|
|Estimated Study Start Date :||January 1, 2020|
|Estimated Primary Completion Date :||December 31, 2020|
|Estimated Study Completion Date :||July 31, 2021|
Active Comparator: Group 1
Home-based remote heart failure management
Procedure: Home-based remote heart failure management
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).
Placebo Comparator: Group 2
Home-based physiological parameter recording only
Procedure: Home-based physiological parameter recording only
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.
No Intervention: Group 3
Patients will receive usual care.
- Composite Primary Endpoints [ Time Frame: 12 months ]composite of re-hospitalization for acute decompensated HF and/or mortality
- 1-year mortality [ Time Frame: 12 months ]1-year mortality
- 1-year heart failure rehospitalization [ Time Frame: 12 months ]1-year heart failure rehospitalization
- Visual analog symptom score [ Time Frame: Continuously for 12 months ]Visual analog symptom score for heart failure
- 6-minute walking distance [ Time Frame: intermittently for 12 months ]6-minute walking distance
- Utilization of evidence-based anti-heart failure medications [ Time Frame: 12 months ]The number and percentage dosage of anti-heart failure medications
- Quality of life [ Time Frame: 12 months ]Minnesota Living with Heart Failure questionnaire