Heart FailureIC-SPECNCT05782075
Biological Monitoring by a Nurse for Heart Failure Patients.
An observational study of Heart Failure, run by Hôpital NOVO at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Remote biological monitoring by a heart failure nurse
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 23 Feb 2023to Apr 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients discharged from the cardiology department of NOVO Hospital with a heart failure episode
Who may be able to join
- 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.
Who cannot join
- 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,
Show all 10Show fewer
- 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,
Trial locations and contacts
1 site in 1 country.
France1 site
Cardiology department - Hospital NOVO - Pontoise site
Pontoise, 95300
About this study
Official title: Biological Monitoring by a Nurse of Post-hospital Heart Failure Patients.
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.
Read the detailed description
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
- Heart Failure
- Being tested
- Remote biological monitoring by a heart failure nurse
- Keywords
- Heart failure, Biological monitoring, Heart failure nurse, Post-hospitalization
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote biological monitoring by a heart failure nurseOther
Review of biological results by a nurse (IDE) trained in heart failure monitoring, alongside the cardiologist, at S1, S2, M1, M2 and M3.
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
The risk of rehospitalization and death will be assessed, to see if a significant difference is observed between IDE decisions and cardiologist decisions, with items listed below :
- Number of interventions initiated,
- Number of rehospitalisation for all causes and for heart failure.
- Number of emergency room visits for heart failure and all causes.
Measured: 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
The risk of death will be assessed by the rate of death for all-cause and cardiac to see if a significant difference is observed between IDE decisions and cardiologist decisions.
Measured: 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)
The impact of the organisation, favourable or unfavourable, on patient outcomes will be assessed by the evolution of the following item :
- Brain natriuretic peptide levels between discharge and three months,
Measured: 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))
The impact of the organisation, favourable or unfavourable, on patient outcomes will be assessed by the evolution of the following item :
- New York Heart Association (NYHA) score from discharge to three months.
Measured: At the end of the patient's follow-up, an average of 3 month
Assessment of the feasibility of the patient monitoring system
The feasibility of the patient monitoring system will be assessed in relation to the number of biological tests not performed.
If the number of biological tests not performed is too high, the patient monitoring system will not be validated.
Measured: At the end of the patient's follow-up, an average of 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2023
- Study start23 Feb 2023
- Primary completionApr 2025 (estimated)
- Study completionApr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hôpital NOVO
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Morgane Gessat, Principal investigator, Hospital NOVO - Pontoise site
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05782075
- Sponsor's protocol ID
- CHRD0323
- Acronym
- IC-SPEC
- Status last verified
- Apr 2024
- First submitted
- 22 Feb 2023
- Last updated
- 31 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 23186936Khan 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.
PubMed 33866827Health 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.
PubMed 28638496Koehler 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.
PubMed 21098580Jourdain 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.
PubMed 17448376
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biological Monitoring by a Nurse of Post-hospital Heart Failure Patients.
- ClinicalTrials.gov ID
- NCT05782075
- Acronym / sponsor ID
- IC-SPEC / CHRD0323
- Conditions
- Heart Failure
- Keywords
- Heart failure, Biological monitoring, Heart failure nurse, Post-hospitalization
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Hôpital NOVOUniversity, hospital or other
- Study start
- 23 Feb 2023 (actual)
- Primary completion
- Apr 2025 (estimated)
- Study completion
- Apr 2025 (estimated)
- First posted
- 23 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients discharged from the cardiology department of NOVO Hospital with a heart failure episode
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Remote biological monitoring by a heart failure nurseReview of biological results by a nurse (IDE) trained in heart failure monitoring, alongside the cardiologist, at S1, S2, M1, M2 and M3. | Other | – |
Primary outcome
Assessment of the concordance, appropriateness and safety of nursing decisions in post-hospitalization heart failure
Time frame: At the end of the patient's follow-up, an average of 3 month
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
5 secondary outcomes
Assessment of the risk of rehospitalisation in the study population between discharge and M3
Time frame: 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
Time frame: 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)
Time frame: 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))
Time frame: At the end of the patient's follow-up, an average of 3 month
Assessment of the feasibility of the patient monitoring system
Time frame: At the end of the patient's follow-up, an average of 3 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2024.
- Background: PubMed 23186936Logeart 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.
- Background: PubMed 33866827Khan 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.
- Background: PubMed 28638496Health 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.
- Background: PubMed 21098580Koehler 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.
- Background: PubMed 17448376Jourdain 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Morgane Gessat principal investigator
Hospital NOVO - Pontoise site
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure, run by Hôpital NOVO at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of the concordance, appropriateness and safety of nursing decisions in post-hospitalization heart failure (time frame: At the end of the patient's follow-up, an average of 3 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05782075, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2024.