Biological Monitoring by a Nurse for Heart Failure Patients.

NCT05782075 | Active Not Recruiting

• 1 other identifier: CHRD0323
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Heart Failure

Keywords

Heart failure; Biological monitoring; Heart failure nurse; Post-hospitalization

Outcome Measures

Primary Outcomes (1)

• Assessment of the concordance, appropriateness and safety of nursing decisions in post-hospitalization heart failure

  The relevance and safety of IDE decisions will be determined by the concordance rate between the decisions made by the cardiologist and the IDE following the biological results at each check-up and after blind review by a second cardiologist

  At the end of the patient's follow-up, an average of 3 month

Secondary Outcomes (5)

• Assessment of the risk of rehospitalisation in the study population between discharge and M3

  At the end of the patient's follow-up, an average of 3 month

• Assessment of the risk of death in the study population between discharge and M3

  At the end of the patient's follow-up, an average of 3 month

• Impact of the organisation on patient outcomes at M3 (Brain natriuretic peptide)

  At the end of the patient's follow-up, an average of 3 month

• Impact of the organisation on patient outcomes at M3 (New York Heart Association (NYHA))

  At the end of the patient's follow-up, an average of 3 month

• Assessment of the feasibility of the patient monitoring system

  At the end of the patient's follow-up, an average of 3 month

Interventions

Remote biological monitoring by a heart failure nurse OTHER

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

Eligibility Criteria

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

Study Population

Patients discharged from the cardiology department of NOVO Hospital with a heart failure episode

You may qualify if:

• 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.

You may not qualify if:

• 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,

Sponsors & Collaborators

• Hôpital NOVO: lead

Study Sites (1)

Cardiology department - Hospital NOVO - Pontoise site

Pontoise, 95300, France

Location

Related Publications (5)

• 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.

  PMID: 23186936 BACKGROUND

• 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.

  PMID: 33866827 BACKGROUND

• 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.

  PMID: 28638496 BACKGROUND

• 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.

  PMID: 21098580 BACKGROUND

• 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.

  PMID: 17448376 BACKGROUND

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Morgane Gessat

  Hospital NOVO - Pontoise site

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2023
• First Posted: March 23, 2023
• Study Start: February 23, 2023
• Primary Completion: April 1, 2025
• Study Completion: April 1, 2025
• Last Updated: December 31, 2024

Record last verified: 2024-04

Locations

FR (1)