RCT Extended and Comprehensive E-health Modalities to Improve OutcomE in Patients with WorseneD Heart Failure (EXCEED-HF)

Recruiting

Conditions: 'heart failure'
10019280

Registration Number: NL-OMON51343

Lead Sponsor: OLVG

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 243

Inclusion Criteria

- Age > 18 years
- Written informed consent
- Permission for data sharing through Luscii heart failure application and/or
Virtual Ward and cBoards telemonitoring programme
- Availability of a proper computer device (including smartphones) for the use
of Luscii heart failure application
- Diagnosis of new onset or chronic heart failure, independent of LVEF, with an
episode of WHF requiring intravenous treatment with diuretics* in the past 7
days before randomization
*WHF for inclusion defined as: HF hospitalization, urgent HF visit resulting in
iv diuretic treatment or outpatient treatment with iv diuretics.

Exclusion Criteria

- New onset heart failure in case of primary reason of admission being
supraventricular tachycardia accompanied by mild decompensation without need
for continuation of diuretics at time of hospital discharge
- Glomerular Filtration Rate (GFR) <20 ml/min (obtained within 2 weeks of the
baseline visit), refractory to diuretic therapy, or on chronic renal dialysis
- Unable to use and/or unavailability of a computer device or smart phone
application
- Simultaneous participation in any other intervention study or remote
monitoring programme is not allowed.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint is a composite of time to all-cause mortality or first WHF<br /><br>event, comparing the intervention on top of standard HF care with standard HF<br /><br>care alone at 180 days of follow-up.<br /><br>The co-primary endpoint is the total number of (recurrent) WHF events at 180<br /><br>days of follow-up.<br /><br>The definition of a WHF event is a HF hospitalization (unscheduled admission ><br /><br>6 hours), urgent HF visit resulting in iv diuretic treatment, outpatient<br /><br>treatment with iv diuretics or outpatient intensification of oral diuretics. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The main secondary endpoints are the total number of the individual components<br /><br>of WHF events (HFH, UHF, outpatient treatment with iv diuretics and outpatient<br /><br>intensification of oral diuretics) at 30 and 180 days follow-up and time to<br /><br>(all-cause and cardiovascular) mortality and first WHF event at 180 days<br /><br>follow-up. Also, the effect of the RM strategy on total number of all cause<br /><br>hospitalizations at 30 and 180 days follow-up will be analysed.<br /><br>Finally, change in quality of life assessed with the KCCQ questionnaire between<br /><br>baseline (T0) and 180 days follow-up is analysed.<br /><br>Exploratory endpoints include health care consumption, cost-effectiveness,<br /><br>medication adherence and patient and caregiver satisfaction.</p><br>