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Acute Heart FailureCHICNCT01834833

Consultation at 8 Days to Reduce Hospitalisations in Heart Failure Patient

A study testing Follow-up in people with Acute Heart Failure, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Evaluate the benefit of systematic appointment with a cardiologist a week after hospitalisation for acute heart failure. Randomised, endpoint: number of day alive out of hospital during 6 months Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Acute Heart Failure
What is being tested?
Follow-up
Could I receive a placebo?
No, everyone receives an active treatment
How many people
326 participants
Where
1 siteFrance
Study dates
May 2013to Jul 2017
Phase
Interventional
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

Criteria of inclusion :

  • Patient with decompensated heart failure hospitalized in the hospital BICHAT,
  • For whom is planned a return at home,
  • Valid (being able to return for a consultation to the hospital)
  • Having Nt-ProBNP of exit ≥ 3500 ng /l and/or a non optimized treatment of exit - according to the doctor who has it the responsibility,
  • Having signed the consent form by participation in the study.

Criteria of not inclusion :

  • Age < 18 years,
  • Not membership in a national insurance scheme or in the Universal Health
  • Coverage (CMU)(FREE UNIVERSAL HEALTH CARE)(A patient benefiting from the Medical aid of the State (AME) cannot be included)
  • Participation to another protocol of research,
  • Not being reachable by telephone in 6 months.

Trial locations and contacts

1 site in 1 country.

France1 site

  • Hopital Bichat Claude Bernard

    Paris, 75018

Other trials in France

About this study

Official title: Consultation at 8 Days to Reduce Hospitalisations in Heart Failure Patient.

Evaluate the benefit of systematic appointment with a cardiologist a week after hospitalisation for acute heart failure. Randomised, endpoint: number of day alive out of hospital during 6 months

Read the detailed description

Background: the risk for rehospitalisation is very high after hospitalisation for acute heart failure. Aim: evaluate the benefit of a consultation with a cardiologist, including echocardiography and education of the patient, between 7 and 15 days after discharge, in high risk patients, identified with BNP or incomplete therapy. Parallel randomised study. The main endpoint is the number of day alive out of hospital during the 6 months post discharge; statistics intention to treat comparison of the number of days alive out of hospital in the group with consultation compared with the group without consultation. Recruitment 3 years and 4 months, follow-up 6 months. Patients included have been hospitalised in hospital BICHAT 75018 Paris, France. Financing is by the ministry of health (PHRQHOS)

Being tested
Follow-up
Keywords
Acute heart failure; rehospitalisation; education; follow-up

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Follow-upOther

    Evaluation by a cardiologist using echocardiography, completed by education of the patient if necessary

Study groups in NCT01834833
Study groupRoleWhat they receive
ControlNo interventionusual care without systematic cardiology evaluation between 1 and 2 weeks
Follow-upExperimentalEvaluation by a cardiologist using echocardiography, completed by education of the patient if necessary
Receives: Other: Follow-up

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. days alive out of hospital 6 months post discharge

    Measured: 6 months

Secondary outcomes (12)

  1. rehospitalisation rate at 6 months

    Measured: 6 months

  2. mortality at 3 and 6 months

    Measured: 3 and 6 months

  3. number of patients receiving beta-blocker at 6 months

    Measured: 6 months

  4. number of patients receiving a ACEI at 6 months

    Measured: 6 months

  5. QOL at 6 months

    Measured: 6 months

  6. autoevaluation of improvement/alteration of the patient state at 6 months

    Measured: 6 months

  7. number of patients receiving beta-blocker at 3 months

    Measured: 3 months

  8. number of patients receiving a ACEI at 3 months

    Measured: 3 months

  9. QOL at 3 months

    Measured: 3 months

  10. autoevaluation of improvement/alteration of the patient state at 3 months

    Measured: 3 months

  11. number of patients having an optimal treatment at 6 months

    Measured: 6 months

  12. number of patients having an optimal treatment at 3 months

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Apr 2013 (estimated)
  2. Study startMay 2013
  3. Primary completionApr 2017
  4. Study completionJul 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
326 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01834833
Sponsor's protocol ID
P110601 - PHRQ1104
Acronym
CHIC
Status last verified
Oct 2018
First submitted
17 Jan 2013
Last updated
23 Oct 2018
Results posted
No
Data monitoring committee
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing Follow-up in people with Acute Heart Failure, run by Assistance Publique - Hôpitaux de Paris 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?

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: finished, as of the sponsor's last update on 23 Oct 2018. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

days alive out of hospital 6 months post discharge (time frame: 6 months). 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 NCT01834833.

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 23 Oct 2018.

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