Heart Failure，CongestiveNCT03202329
Evaluation of Post-operative, Nurse-based Heart Failure Care in Non-cardiac Surgery
A study testing Nurse-based care in people with Heart Failure，Congestive, run by Birgit Assmus at 2 sites in Germany.
Trial summary
Patients with heart failure NYHA >= II receiving non-emergent non-cardiac in-patient surgery will be randomized to receive either standard post-operative care (surgeon has to ask actively for specialist cardiological support) or a nurse-based heart failure management (nurses provide week-day support every day after… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure，Congestive
- What is being tested?
- Nurse-based care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 525 participants
- Where
- 2 sitesGermany
- Study dates
- 1 Oct 2017to 1 Jun 2021
- 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
Who may be able to join
- patients with heart failure NYHA >= II (HFrEF and HFpEF) or LVEF <= 40% non-cardiac surgery planned later than 24 hours age > 18 years written informed consent
Who cannot join
- patients on intensive care life-expectancy < 3 months
Trial locations and contacts
2 sites in 1 country.
Germany2 sites, 2 recruiting
- Enrolling by invitation
Goethe University Hospital
Frankfurt am Main, Hesse, 60590
- Recruiting
Klinikum Goethe University
Frankfurt am Main, 60590
Birgit Assmus, MD, +49 69 6301 ext. 84690, birgit.assmus@kgu.de
Andreas Ecke, MD, +49 69 6301 ext. 84690, andreas.ecke@kgu.de
About this study
Official title: Evaluation of Post-operative, Nurse-based Heart Failure Care Compared to Standard Treatment in Patients With Heart Failure Undergoing Non-cardiac Surgery
Patients with heart failure NYHA >= II receiving non-emergent non-cardiac in-patient surgery will be randomized to receive either standard post-operative care (surgeon has to ask actively for specialist cardiological support) or a nurse-based heart failure management (nurses provide week-day support every day after surgery, if needed together with a heart failure doctor)
- Conditions
- Heart Failure，Congestive
- Being tested
- standard care, Nurse-based care
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
standard careOther
cardiologists assist in treatment and provide heart failure guidance post-operatively if required by the treating surgeon
Nurse-based careOther
board-certified heart failure nurses provide heart failure guidance post-operatively on every working day
| Study group | Role | What they receive |
|---|---|---|
| standard care | Other | responsible surgeon has actively to ask for cardiology support (he decides whether a heart failure specialist should see the patient post-operatively) Receives: Other: standard care |
| nurse-based care | Other | heart failure nurses visit postoperatively every (working-) day to check fluid balance, medication, rhythm and general condition Receives: Other: Nurse-based care |
What is being measured
The primary outcome is the main question the study is designed to answer.
composite endpoint of in-hospital heart failure-related complications (readmission on ICU, re-initiation of inotropic support, pleural effusion, pulmonary edema, pneumonia requiring antibiotic treatment, non-invasive or invasive ventilation)
severe heart-failure related clinical events during hospitalisation for non-cardiac surgery
Measured: 30 days
Secondary outcomes (3)
days in hospital
total days in hospital for non-cardiac surgery
Measured: 90 days
acute kidney injury
Acute kidney injury grade: 0 = Creatinine increase < 1,5 x baseline, Stage 1 Creatinine increase > 1,5 x baseline, Stage 2 Creatinine increase > 2 x baseline, Stage 3 Creatinine increase > 3 x baseline)
Measured: 90 days
Qulity of Life by SF-12
repetitive assessment with SF-12
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2017
- Study start1 Oct 2017
- Primary completion1 Dec 2020 (estimated)
- Study completion1 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure，CongestiveStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 525 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Birgit Assmus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Birgit Assmus, Johann Wolfgang Goethe University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03202329
- Sponsor's protocol ID
- HFS-01
- Status last verified
- Jul 2020
- First submitted
- 27 Jun 2017
- Last updated
- 28 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Post-operative, Nurse-based Heart Failure Care Compared to Standard Treatment in Patients With Heart Failure Undergoing Non-cardiac Surgery
- ClinicalTrials.gov ID
- NCT03202329
- Acronym / sponsor ID
- HFS-01
- Conditions
- Heart Failure，Congestive
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 525 participants (estimated)
- Lead sponsor
- Birgit AssmusUniversity, hospital or other
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 1 Dec 2020 (estimated)
- Study completion
- 1 Jun 2021 (estimated)
- First posted
- 28 Jun 2017 (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.
Patients with heart failure NYHA >= II receiving non-emergent non-cardiac in-patient surgery will be randomized to receive either standard post-operative care (surgeon has to ask actively for specialist cardiological support) or a nurse-based heart failure management (nurses provide week-day support every day after surgery, if needed together with a heart failure doctor)
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| standard care | Other | Other: standard careresponsible surgeon has actively to ask for cardiology support (he decides whether a heart failure specialist should see the patient post-operatively) |
| nurse-based care | Other | Other: Nurse-based careheart failure nurses visit postoperatively every (working-) day to check fluid balance, medication, rhythm and general condition |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients with heart failure NYHA >= II (HFrEF and HFpEF) or LVEF <= 40% non-cardiac surgery planned later than 24 hours age > 18 years written informed consent
Key exclusion criteria (1 listed)
- patients on intensive care life-expectancy < 3 months
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 |
|---|---|---|
| standard carecardiologists assist in treatment and provide heart failure guidance post-operatively if required by the treating surgeon | Other | standard care |
| Nurse-based careboard-certified heart failure nurses provide heart failure guidance post-operatively on every working day | Other | nurse-based care |
Primary outcome
composite endpoint of in-hospital heart failure-related complications (readmission on ICU, re-initiation of inotropic support, pleural effusion, pulmonary edema, pneumonia requiring antibiotic treatment, non-invasive or invasive ventilation)
Time frame: 30 days
severe heart-failure related clinical events during hospitalisation for non-cardiac surgery
3 secondary outcomes
days in hospital
Time frame: 90 days
acute kidney injury
Time frame: 90 days
Qulity of Life by SF-12
Time frame: 90 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2020.
- Individual participant dataSharing planned: Undecided
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nurse-based care in people with Heart Failure，Congestive, run by Birgit Assmus at 2 sites in Germany.
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 1 inclusion and 1 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 28 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. 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?
Contact Birgit Assmus, MD (+49696301 ext. 5789, birgit.assmus@kgu.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
composite endpoint of in-hospital heart failure-related complications (readmission on ICU, re-initiation of inotropic support, pleural effusion, pulmonary edema, pneumonia requiring antibiotic treatment, non-invasive or invasive ventilation) (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Jul 2020.