Remote Supervision to Decrease Hospitalization Rate (RESULT)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 600
- Locations
- 1
- Primary Endpoint
- The primary endpoint of the trial will be composite: death for any reason or hospitalization due to cardiovascular reasons.
Study Overview
Brief Summary
Purpose: Home monitoring (HM) services supplied by different manufacturers (St Jude Medical, Biotronik, Medtronic) enables trained medical staff (doctors, electrophysiology nurses and technicians) to safely follow-up patients with implanted ICD/CRT-D remotely, with omitting unnecessary visits in outpatient clinic, shortening time to medical intervention and therefore help to decrease hospitalization rate among those patients.
The RESULT study primary endpoint of the trial will be a composite of all-cause death or hospitalization due to cardiovascular reasons.
The primary technical endpoint is to construct and evaluate a unified and integrated platform for data collected from RM devices manufactured by different companies: Carelink™ (Medtronic®, Minneapolis, MN, USA), Merlin™ (Saint Jude Medical®, St. Paul, MN, USA) and Home Monitoring™ (Biotronik®, Berlin, Germany).
Detailed Description
The RESULT trial is a prospective, single-center, randomized, open label, parallel study. All consecutive patients with symptomatic HF and reduced ejection fraction (≤ 35%) with ICDs or CRT-Ds implanted accordingly to current ESC practice guidelines will be prospectively randomized in a 1:1 fashion to either a traditional or an RM-based follow-up model. Six hundred patients will be enrolled. The inclusion and exclusion criteria are shown in Table 1. The clinical status of patients will be estimated using the composite endpoint of all-cause death and hospitalization due to cardiovascular reasons. The study protocol has been approved by a local ethics committee and complies with the Declaration of Helsinki. A written informed consent will be obtained from all study participants. Primary endpoint The primary endpoint of the trial will be a composite of all-cause death or hospitalization due to cardiovascular reasons. Hospitalization for cardiovascular reasons should consist of:
- Hospitalization due to progression of heart failure.
- Hospitalization due to persistent arrhythmia (AF, VT).
- Hospitalization due to embolic episode.
- Hospitalization due to acute coronary syndrome. Every patient will be followed for at least 12 months after randomization. Assessment of hospitalization events for cardiovascular reasons will be performed according to a recently published consensus [13]. The final classification of hospital admissions due to cardiovascular reasons will be made by a blinded endpoints committee. The primary technical endpoint is to construct and evaluate a unified and integrated platform for data collected from RM devices manufactured by different companies: Carelink™ (Medtronic®, Minneapolis, MN, USA), Merlin™ (Saint Jude Medical®, St. Paul, MN, USA) and Home Monitoring™ (Biotronik®, Berlin, Germany). Secondary endpoints Both elements combined in the primary endpoint will be analyzed separately to estimate their relative impact on the primary endpoint.
The secondary endpoints include the following:
- All-cause death.
- Hospitalization due to cardiovascular reasons.
- Time to medical intervention in case of relevant incidents (arrhythmic, device malfunction, signs of HF decompensation).
- Average number of visits to an outpatient clinic (scheduled and unscheduled) per patient.
- Time to first unscheduled visit in an outpatient clinic.
- Incidence of inappropriate ICD shocks.
- Proportion of visits to outpatient clinics with relevant findings (necessity of changes of device programming or pharmacological therapy, rehospitalization, interventions, invasive procedures).
- Assessment of quality of life of living study participants according to the Minnesota Quality of Life Questionnaire.
- Cost-effectiveness, defined as the cost of hospitalizations and/or scheduled and unscheduled visits in both groups.
All consecutive patients after implantation of an ICD or CRT-D manufactured by St.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age 18-80 years
- •EF≤35% prior to implantation
- •Period up to 30 days after implantation (ICD/CRT-D) according to ESC guidelines
- •Agreement for telemetric supervision
- •Informed consent for clinical trial.
Exclusion Criteria
- •Existence of factors that may cause risk for lack of cooperation in trial regimen (distant residence, mental illness, lack of skills in operating simple electronic devices).
- •unavailability of mobile network service in the place of residence/stay.
- •Device implanted during intravenous administration of inotropic agents.
Arms & Interventions
HM option not active.
Regular visits in outpatient clinic. Device: no HM
Intervention: no Home Monitoring (Device)
Home Monitoring
Remote monitoring od ICD/CRT-D function and patient condition. Device: HM provided by St Jude Medical, Biotronik or Medtronic.
Intervention: Home Monitoring (Device)
Outcomes
Primary Outcomes
The primary endpoint of the trial will be composite: death for any reason or hospitalization due to cardiovascular reasons.
Time Frame: 12 months
Secondary Outcomes
- proportion of visits in outpatient clinic with relevant findings (necessity of changes of device programming or pharmacological therapy, re-hospitalization, interventions, invasive procedures)(12 months)
- costs of treatment of patients with implanted ICD/CRT-D in both arms of the study (hospitalization, control visits)(12 months)
- average number of visits in outpatient clinic (scheduled and unscheduled) per patient(12 months)
- incidence of inappropriate ICD shocks(12 months)
- time to medical intervention in case of relevant incidents (arrhythmic, device malfunction, signs heart failure decompensation) in both arms of the study(12 months)
- changes in quality of life (Minnesota Quality of Life Questionnaire )(baseline and after 12 months)
- time to first unscheduled visit in outpatient clinic(12 months)
Investigators
Lech Polonski
Professor, PhD, MD
Silesian Centre for Heart Diseases