Multidimensional Impact of Telemonitoring in Heart Failure (IMPACT-HF)

NCT05653726 | Recruiting DMC

• 1 other identifier: HU12Octubre
• Study Type: interventional
• Target: 390
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to know if telemonitoring and telematic follow-up reduces the healthcare resources utilization, healthcare costs and non-healthcare costs of patients with high-risk heart failure. The main questions it aims to answer are:

• Does telematic follow-up reduce de use of healthcare resource utilization of patients with heart failure?
• Is telematic follow-up cost-efficient in terms of reducing direct healthcare costs in heart failure patients?
• Is telematic follow-up cost-efficient in terms of reducing non-healthcare costs in heart failure patients? Participants will be randomized to usual care (control group) or telematic care (interventional group). Patients randomized to the interventional group will be included in a protocol of daily automatic telemonitoring of arterial pressure, peripheral oximetry, heart rate and weight, and telematic consultations lead by a heart failure clinical specialized team. Researchers will compare the healthcare resource utilization, healthcare and non-healthcare costs of patients randomized to control vs. interventional group.

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

• Health care costs

  Sum of the costs for the consumption of medicines, primary care consultations, specialist consultations, hospitalization, emergency care and medical transport.

  12 months

Secondary Outcomes (8)

• Non-health care costs

  12 months

• Symptoms

  12 months

• Care burden of caregivers

  12 months

• Number of hospital admissions

  12 months

• Mortality

  12 months

Study Arms (2)

Telemonitoring group

EXPERIMENTAL

Follow-up group by telematic consultations and non-invasive daily telemonitoring of weight, blood pressure, heart rate, peripheral oxygen saturation and electrocardiogram.

Other: Telemonitoring follow-up using medical devices and telematic consultations

Control gropu

NO INTERVENTION

Usual care follow-up group

Interventions

Telemonitoring follow-up using medical devices and telematic consultations OTHER

Home telemonitoring of blood pressure, heart rate and peripheral oxygen saturation on a daily basis during 12 months

Telemonitoring group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of HF according to the 2021 guidelines of the European Society of Cardiology criteria for ≥3 months.
• Admitted for decompensation of chronic HF.
• Admitted for HF decompensation ≥30 days and ≤6 months.
• HF decompensation in ≥30 days and ≤6 months but discharged directly from the emergency department or managed on an outpatient basis, but requiring intravenous diuretic administration in an ambulatory basis, or \>50% increase in loop diuretic dose.
• With previous optimized prognostic medical treatment.
• Under treatment with loop diuretic drugs.
• New York Heart Association functional class II, III or IV.

You may not qualify if:

• Hemodynamic instability.
• Acute myocardial infarction, acute pulmonary thromboembolism or stroke in the previous 40 days.
• Uncontrolled arrhythmias
• On waiting list for transplantation (any organ) or other cardiac surgery.
• Advanced mechanical circulatory support.
• Chronic renal disease on hemodialysis.
• Life expectancy less than 1 year.
• Moderate-severe cognitive impairment.
• Manifest inability to use a technological system.
• Institutionalized.
• Limiting psychiatric pathology.

Sponsors & Collaborators

• Hospital Universitario 12 de Octubre: lead
• Consorcio Centro de Investigación Biomédica en Red (CIBER): collaborator
• Fundacion Investigacion Biomedica Hospital 12 de Octubre: collaborator
• Hospital Universitario Puerta de Hierro de Majadahonda: collaborator

Study Sites (1)

Hospital Universitario 12 de Octubre

Madrid, Madrid, Spain

RECRUITING

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Central Study Contacts

Juan Carlos López-Azor García, MD, PhD

CONTACT

+34628026462; lopez.gcia.juan.carlos@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Doctor in Medicine

Study Record Dates

• First Submitted: November 28, 2022
• First Posted: December 16, 2022
• Study Start: November 29, 2023
• Primary Completion: June 15, 2025
• Study Completion: December 31, 2025
• Last Updated: November 27, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)