Evaluation of Post-operative, Nurse-based Heart Failure Care in Non-cardiac Surgery

NCT ID: NCT03202329

Last Updated: 2020-07-28

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

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

525 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-01

Study Completion Date

2021-06-01

Brief Summary

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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)

Detailed Description

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Conditions

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Heart Failure,Congestive

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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standard care

responsible surgeon has actively to ask for cardiology support (he decides whether a heart failure specialist should see the patient post-operatively)

Group Type OTHER

standard care

Intervention Type OTHER

cardiologists assist in treatment and provide heart failure guidance post-operatively if required by the treating surgeon

nurse-based care

heart failure nurses visit postoperatively every (working-) day to check fluid balance, medication, rhythm and general condition

Group Type OTHER

Nurse-based care

Intervention Type OTHER

board-certified heart failure nurses provide heart failure guidance post-operatively on every working day

Interventions

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standard care

cardiologists assist in treatment and provide heart failure guidance post-operatively if required by the treating surgeon

Intervention Type OTHER

Nurse-based care

board-certified heart failure nurses provide heart failure guidance post-operatively on every working day

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

patients on intensive care life-expectancy \< 3 months
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Birgit Assmus

OTHER

Sponsor Role lead

Responsible Party

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Birgit Assmus

Prof. Dr. med.

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Goethe University Hospital

Frankfurt am Main, Hesse, Germany

Site Status ENROLLING_BY_INVITATION

Klinikum Goethe University

Frankfurt am Main, , Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Birgit Assmus, MD

Role: CONTACT

+49696301 ext. 5789

Andreas M Zeiher, MD

Role: CONTACT

+49696301 ext. 84690

Facility Contacts

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Birgit Assmus, MD

Role: primary

+49 69 6301 ext. 84690

Andreas Ecke, MD

Role: backup

+49 69 6301 ext. 84690

Other Identifiers

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HFS-01

Identifier Type: -

Identifier Source: org_study_id

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