N/A N=937 Randomized Prevention

Optimization of the Ambulatory Monitoring for Patients With Heart Failure by Tele-cardiology

Chronic Heart Failure

Bottom Line

View on ClinicalTrials.gov: NCT02068118 ↗

Enrolled (actual)

937

Serious AEs

—

Results posted

Oct 2021

Primary outcome: Primary: Number of All Causes Deaths and (Unplanned) Hospitalizations — 1.46; 1.30 Events — p==0.80

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Telecardiology program (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: CDM e-Health
Primary completion: Dec 2017

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of All Causes Deaths and (Unplanned) Hospitalizations	1.46; 1.30	=0.80
PRIMARY Number of All Causes Deaths and (Unplanned) Hospitalizations in NYHA Class III or IV Patients	1.99; 1.53	=0.18
PRIMARY Number of All Causes Deaths and (Unplanned) Hospitalizations in Socially Isolated Patients	1.89; 1.30	=0.02 sig
SECONDARY Time to First Unplanned Hospital Readmission or Death From Any Cause	84; 105	=0.68
SECONDARY All Causes Deaths - Number of Patients Who Died From Any Cause	89; 91	—
SECONDARY Time to Death From Any Cause	233; 252	=0.85
SECONDARY Number of Unplanned Hospitalizations for Any Cause	1.27; 1.11	=0.77
SECONDARY Number of Deaths and Unplanned Hospitalizations From Cardiovascular Cause	1.07; 0.96	=0.83
SECONDARY Number of Unplanned Hospitalizations for Heart Failure	0.75; 0.59	=0.28
SECONDARY Number of Unplanned Hospitalizations for Heart Failure in NYHA Class III or IV Patients	1.02; 0.70	=0.078
SECONDARY Number of Unplanned Hospitalizations for Heart Failure in Socially Isolated Patients	1.00; 0.58	=0.023 sig
SECONDARY Time to First Unplanned Hospital Readmission for Heart Failure	79; 97	=0.044 sig
SECONDARY Evolution of Quality of Life Assessed by Short Form-36 (SF-36) Questionnaire Scores	-1.3; 0.0; 2.4; 1.3; 12.5; 12.5	=0.17
SECONDARY Annualized Number of Unplanned Hospitalizations for Any Cause During the Extension Period	1.30; 3.30	—
SECONDARY Number of Patients Who Died From Any Cause During the Extension Period	0; 2	—
SECONDARY Annualized Number of Unplanned Hospitalizations From Cardiovascular Cause During the Extension Period	1.30; 2.84	—
SECONDARY Number of Patients Who Died From Cardiovascular Cause During the Extension Period	0; 0	—

Summary

Targeted population: Patients with heart failure causing hospitalization during the last twelve months. Hypothesis: The number of all cause deaths and hospitalizations will be smaller for the Telecardiology group than for the reference group (standard follow-up care). An 18 months period of observation is required. Main goal: To compare the rate of all cause deaths and hospitalizations of patients with heart failure between the Telecardiology group and the reference group after 18 months of monitoring.

Eligibility Criteria

Inclusion Criteria

Aged 18 years or older
Men or women patient with heart failure having been hospitalized for cardiac decompensation during the last 12 months.
Patient with access to a wireline telephone service or GPRS network.
The patient is willing and able to sign an informed written consent
Patient is insured under the social security system

Exclusion Criteria

No available echocardiographic evaluation.
BNP lower than 100pg/ml or NT-proBNP lower than 300pg/ml
A prognosis of a life span of less than 12 months (apart from heart failure)
Dialysis patients
Heart transplant or cardiac assist devices
Patients involved in inotropic treatment
Patient doesn't have the necessary autonomy to use the equipment
Patient enrolled in another clinical trial
A pregnant or nursing woman, or patient of reproductive age who doesn't use contraceptives
Patients under tutorship, curatorship or judicial protection

Inclusion Criteria in the extension period:

Participation in the open extension period is only offered to patients who participated in the comparative period of the study, did not withdraw prematurely from the latter and gave their free informed written consent to participate to the extension period.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02068118). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.