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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
Sponsor:
Collaborators:
Chinese University of Hong Kong
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Dr. David Siu, The University of Hong Kong

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.


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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 876 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. Composite Primary Endpoints [ Time Frame: 12 months ]
    composite of re-hospitalization for acute decompensated HF and/or mortality


Secondary Outcome Measures :
  1. 1-year mortality [ Time Frame: 12 months ]
    1-year mortality

  2. 1-year heart failure rehospitalization [ Time Frame: 12 months ]
    1-year heart failure rehospitalization

  3. Visual analog symptom score [ Time Frame: Continuously for 12 months ]
    Visual analog symptom score for heart failure

  4. 6-minute walking distance [ Time Frame: intermittently for 12 months ]
    6-minute walking distance

  5. Utilization of evidence-based anti-heart failure medications [ Time Frame: 12 months ]
    The number and percentage dosage of anti-heart failure medications

  6. Quality of life [ Time Frame: 12 months ]
    Minnesota Living with Heart Failure questionnaire



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

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Responsible Party: Dr. David Siu, Professor, The University of Hong Kong
ClinicalTrials.gov Identifier: NCT03072693     History of Changes
Other Study ID Numbers: CARDIAC_HF_1
First Posted: March 7, 2017    Key Record Dates
Last Update Posted: August 13, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases