Telemedical Interventional Management in Heart Failure II

Phase 3

Completed

• Conditions: Chronic Heart Failure

• Registration Number: NCT01878630
• Lead Sponsor: Charite University, Berlin, Germany

Brief Summary

Superiority of additional Remote Patient Management (RPM) in patients with chronic heart failure (CHF) in comparison to usual care in terms of, e.g.:

* days lost due to unplanned cardiovascular hospitalization or death

* all-cause mortality

* cardiovascular mortality

* quality of life

Detailed Description

The clinical trial assesses 1,500 patients over a period of 12 months each (2013 until 2015). All participants will continue to receive usual care from their general practitioner and specialist. All patients will be examined at the beginning of the study and will undergo a check-up every 3 months. 750 of the patients will be randomly allocated to receive devices for Remote Patient Management (RPM) which will measure various parameters on a daily basis (e.g. weight, blood pressure, heart rate). The devices are mobile and can be used at home or elsewhere.

Study Timeline

• Study First Submitted: 2013-06-12
• Study First Submitted QC: 2013-06-14
• Study First Posted: 2013-06-17
• Study Start: 2013-08-08
• Primary Completion: 2017-05-12
• Study Completion: 2018-05-17
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-02
• Last Update Posted: 2018-08-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1571

Inclusion Criteria

• chronic heart failure New York Heart Association (NYHA) class II or III
• echocardiographically determined left ventricular ejection fraction (LVEF) ≤45% or >45% + minimum 1 diuretic in permanent medicinal therapy
• hospitalization due to decompensated HF within the last 12months before randomization
• informed consent
• Depression score PHQ-9: <10

Exclusion Criteria

• hospitalization within the last 7 days before randomization
• implanted cardiac assist system
• acute coronary syndrome within the last 7 days before randomization
• high urgent listed for heart transplantation (HTx)
• planned revascularization, Transcatheter Aortic Valve Implantation (TAVI), MitraClip and/or Cardiac Resynchronization Therapy (CRT)-implantation within the last 3 months before randomization
• revascularization and/or CRT-implantation within 28 days before randomization
• known alcohol or drug abuse
• terminal renal insufficiency with hemodialysis
• impairment or unwillingness to use the telemonitoring equipment (e.g. dementia, impaired self-determination, lacking ability to communicate)
• existence of any disease reducing life expectancy to less than 1 year
• age <18 years
• pregnancy
• participation in other treatment studies or remote patient management programmes (register studies possible)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Percentage of days lost due to unplanned cardiovascular (CV) hospitalisation or due to death for any reason during the individual patient follow-up time.	12 months/ individual-patient follow-up time.	The primary outcome analysis will be performed on the FAS using the adjudicated data and sensitivity analyses will be performed on a) the PP data set, and b) on the FAS censoring all data at day 365.

Secondary Outcome Measures

Name	Time	Method
Percentage of days lost due to unplanned HF-hospitalisations during the individual patient follow-up time	12 months/ individual follow-up time
Percentage of days lost due to unplanned cardiovascular hospitalisations during the individual patient follow-up time.	12 months/ individual follow-up time
Change in MLHFQ-questionnaire overall score between baseline and 365 days	12 months/ individual follow-up time	The change in MLHFQ (Minnesota Living with Heart Failure Questionnaire) scores will be analysed using an analysis of covariance and the corresponding estimates with 95% confidence intervals and p-values will be provided.
Change in levels of NT-proBNP and of MR-proADM between baseline and 365 days.	12 months/ individual follow-up time	The change in NT-proBNP and of MR-proADM levels will be analysed using an analysis of covariance and the corresponding estimates with 95% confidence intervals and p-values will be provided
All-cause mortality during the individual patient follow-up time.	individual patient follow-up time (+28 days of the final visit to a maximum 393 days)	All-cause and cardiovascular mortality will be calculated as: The individual follow-up time as calculated for the primary outcome + 28 days for all patients to a maximum of 393 days.

Trial Locations

Locations (107)

Klinikum St. Marien Amberg - Medizinische Klinik I; 🇩🇪 Amberg, Germany

GLG Fachklinik Wolletzsee GmbH; 🇩🇪 Angermünde, Germany

Klinik Ernst von Bergmann Bad Belzig gGmbH - Zentrum für Innere Medizin/Kardiologie; 🇩🇪 Bad Belzig, Germany

Oder-Spree-Krankenhaus Beeskow GmbH; 🇩🇪 Beeskow, Germany

Charité - Universitaetsmedizin Berlin; 🇩🇪 Berlin, Germany

Bundeswehr Krankenhaus; 🇩🇪 Berlin, Germany

Cardio Centrum Berlin GmbH; 🇩🇪 Berlin, Germany

DRK Kliniken Berlin-Köpenick; 🇩🇪 Berlin, Germany

Gemeinschaftskrankenhaus Havelhöhe Klinik für Anthroposophische Medizin; 🇩🇪 Berlin, Germany

Gemeinschaftspraxis am Bayerischen Platz; 🇩🇪 Berlin, Germany

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