Biological Monitoring by a Nurse for Heart Failure Patients.

NCT ID: NCT05782075

Last Updated: 2024-12-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-02-23

Study Completion Date

2025-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The aim of this study is to evaluate the feasibility and safety of delegating remote biological monitoring in post-hospitalization for cardiac decompensation by a heart failure nurse.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Chronic heart failure is a major public health issue in France. It is the leading cause of hospitalisation in people over 65 years of age and results in many costly and potentially avoidable hospital stays. One third of patients are readmitted to hospital within 3 months of discharge.

A remote monitoring programme and natriuretic peptide monitoring during this vulnerable period can help improve patient management, reducing rehospitalisation rates, emergency room visits and mortality.

Given the increasing pressure on already limited healthcare resources, it is important to examine the delegation of care to specialist nurses, as well as their safety.

This study aims to evaluate the feasibility and safety of delegating remote biological monitoring in post-hospitalization for cardiac decompensation by a heart failure nurse.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Heart Failure

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Heart failure Biological monitoring Heart failure nurse Post-hospitalization

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Remote biological monitoring by a heart failure nurse

Review of biological results by a nurse (IDE) trained in heart failure monitoring, alongside the cardiologist, at S1, S2, M1, M2 and M3.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patient ≥18 years old,
* Patient hospitalised for heart failure and discharged,
* Glomerular filtration rate at discharge \> 20ml/min/1.73m²,
* Patient informed and agree to participate,
* Patient able to carry out the follow-up proposed by the cardiology department.

Exclusion Criteria

* Cognitive disorders with Codex test category C and D,
* Barrier of the language,
* Psychiatric disorder that may interfere with treatment,
* Major surgery scheduled within 3 months,
* Excessive alcohol or drug use with no desire to withdraw
* Cardiac amyloidosis,
* Terminal heart failure,
* Patient discharged to specialised Care and Rehabilitation department,
* Any disease other than cardiac with a life expectancy of less than 1 year according to the investigator,
* Patient under guardianship,
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Hôpital NOVO

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Morgane Gessat

Role: PRINCIPAL_INVESTIGATOR

Hospital NOVO - Pontoise site

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Cardiology department - Hospital NOVO - Pontoise site

Pontoise, , France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

References

Explore related publications, articles, or registry entries linked to this study.

Logeart D, Isnard R, Resche-Rigon M, Seronde MF, de Groote P, Jondeau G, Galinier M, Mulak G, Donal E, Delahaye F, Juilliere Y, Damy T, Jourdain P, Bauer F, Eicher JC, Neuder Y, Trochu JN; Heart Failure of the French Society of Cardiology. Current aspects of the spectrum of acute heart failure syndromes in a real-life setting: the OFICA study. Eur J Heart Fail. 2013 Apr;15(4):465-76. doi: 10.1093/eurjhf/hfs189. Epub 2012 Nov 27.

Reference Type BACKGROUND
PMID: 23186936 (View on PubMed)

Khan MS, Sreenivasan J, Lateef N, Abougergi MS, Greene SJ, Ahmad T, Anker SD, Fonarow GC, Butler J. Trends in 30- and 90-Day Readmission Rates for Heart Failure. Circ Heart Fail. 2021 Apr;14(4):e008335. doi: 10.1161/CIRCHEARTFAILURE.121.008335. Epub 2021 Apr 19.

Reference Type BACKGROUND
PMID: 33866827 (View on PubMed)

Health Quality Ontario. Effect of Early Follow-Up After Hospital Discharge on Outcomes in Patients With Heart Failure or Chronic Obstructive Pulmonary Disease: A Systematic Review. Ont Health Technol Assess Ser. 2017 May 25;17(8):1-37. eCollection 2017.

Reference Type BACKGROUND
PMID: 28638496 (View on PubMed)

Koehler F, Winkler S, Schieber M, Sechtem U, Stangl K, Bohm M, Boll H, Kim SS, Koehler K, Lucke S, Honold M, Heinze P, Schweizer T, Braecklein M, Kirwan BA, Gelbrich G, Anker SD; TIM-HF Investigators. Telemedical Interventional Monitoring in Heart Failure (TIM-HF), a randomized, controlled intervention trial investigating the impact of telemedicine on mortality in ambulatory patients with heart failure: study design. Eur J Heart Fail. 2010 Dec;12(12):1354-62. doi: 10.1093/eurjhf/hfq199.

Reference Type BACKGROUND
PMID: 21098580 (View on PubMed)

Jourdain P, Jondeau G, Funck F, Gueffet P, Le Helloco A, Donal E, Aupetit JF, Aumont MC, Galinier M, Eicher JC, Cohen-Solal A, Juilliere Y. Plasma brain natriuretic peptide-guided therapy to improve outcome in heart failure: the STARS-BNP Multicenter Study. J Am Coll Cardiol. 2007 Apr 24;49(16):1733-9. doi: 10.1016/j.jacc.2006.10.081. Epub 2007 Apr 2.

Reference Type BACKGROUND
PMID: 17448376 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CHRD0323

Identifier Type: -

Identifier Source: org_study_id