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Heart Valve DiseasesINCREASENCT04977362

Interdisciplinary Perioperative Care in Minimally-invasive Heart Valve Surgery

A study testing Enhanced Recovery After Surgery and Treatment as Usual in people with Heart Valve Diseases, run by Universitätsklinikum Hamburg-Eppendorf at 2 sites in Germany.

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

Valvular heart diseases are among the most common cardiac pathologies in adult patients in Germany. Currently, the process of care before, during and after heart valve surgery does not follow a standardized and interdisciplinary optimal approach. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Heart Valve Diseases
What is being tested?
Enhanced Recovery After Surgery and Treatment as Usual
Could I receive a placebo?
No, everyone receives an active treatment
How many people
201 participants
Where
2 sitesGermany
Study dates
1 Jul 2021to 30 Jun 2024
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

  • Indication for elective minimally invasive (open) aortic or mitral valve surgery
  • Patient's ability to understand the nature and extent of the individual's requirements for participation in the new care setting
  • Classification of the patient as "FIT" or "Pre-FRAIL" using the LUCAS functional index (frailty index) (Dapp et al. 2012)

Who cannot join

  • Limited life expectancy less than one year (e.g., advanced tumor disease)
  • Urgent or emergency interventions
  • Severe chronic obstructive pulmonary disease (GOLD III or IV)
  • Dialysis-dependant renal failure
  • Advanced liver cirrhosis (Child stages B + C)
  • Severe comorbidities or psychosocial reasons that militate against participation or do not allow for written informed consent (e. g., residual neurological impairment after prior stroke, major restrictions of mobility, neuropsychological disorders, depressive disorder, substance-related addictive disorders)
  • Lack of a social environment that can provide supportive patient care
  • Previous cardiac surgery (i.e., relative contraindication for minimally invasive technique)

Trial locations and contacts

2 sites in 1 country.

Germany2 sites

  • Universitätsklinikum Augsburg

    Augsburg, Bavaria, 86156

  • Universitätsklinikum Hamburg-Eppendorf

    Hamburg, 20246

Other trials in Germany

About this study

Official title: Interdisciplinary and Cross-sectoral Perioperative Care Model in the Cardiac Surgery: Implementation in the Setting of Minimally-invasive Heart Valve Surgery (INCREASE)

Valvular heart diseases are among the most common cardiac pathologies in adult patients in Germany. Currently, the process of care before, during and after heart valve surgery does not follow a standardized and interdisciplinary optimal approach. An approach already established in other surgical disciplines is the Enhanced Recovery After Surgery (ERAS) protocol, which aims at optimizing the recovery process of patients. Within the INCREASE study, a care process inspired by the ERAS protocol will be established at the University Heart and Vascular Center (UHZ) of the University Medical Center Hamburg-Eppendorf (UKE) and the University Medical Center Augsburg (UKA). Executing the study at two facilities in different regions in Germany will help to demonstrate transferability of the process of care. The effectiveness of this process compared to the current treatment approach will be investigated in a randomized controlled trial. A total of 186 patients will be allocated by chance either to the intervention group (ERAS protocol) or the control group (treatment as usual). Patients in the intervention group will receive an optimized interdisciplinary care protocol including medical, nursing, physiotherapeutical and psychotherapeutical interventions. Measurements of effectiveness are the number of hospitalized days (due to cardiac causes) within one year and the physical condition of the patient as measured by the 6-minute walk test (6MWT) on the day of discharge.

Being tested
Enhanced Recovery After Surgery, Treatment as Usual
Keywords
randomized controlled trial, enhanced recovery after surgery, minimally invasive surgery, postanesthesia care unit, physiotherapy
Medical subject headings
Heart Valve Diseases

What participants receive

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

  • Enhanced Recovery After SurgeryOther

    Also called fast track, rapid recovery, ERAS

    Enhanced recovery after surgery is a multimodal, transdisciplinary care approach for patients undergoing surgical procedures. It is implemented in various surgical specialties, among others in cardiac surgery. The care approach aims at promotion of recovery of the patients throughout their perioperative process, reduction of complications, and early return to normal activities.

  • Treatment as UsualOther

    treatment as usual according to standard care in heart valve surgery

Study groups in NCT04977362
Study groupRoleWhat they receive
ERAS protocol (intervention group)ExperimentalThe innovative care process in the intervention group is characterized by an interdisciplinary approach according to the previously established enhanced recovery after surgery protocol. This process aims at improving the clinical outcome after cardiac surgery, increasing patient satisfaction and quality of life, enabling early professional reentry and participation, and optimizing the cost-effectiveness of service provision. In addition, intersectoral barriers are being broken down in order to establish an interdisciplinary and cross-sectoral overall care process for patients with heart valve surgery as a new form of care in the future.
Receives: Other: Enhanced Recovery After Surgery
Treatment as usual (control group)Active comparatorThe control group undergoes standard heart valve surgery. In this case, no preoperative interventions take place, the patient is operated on the affected heart valve in a minimally invasive procedure without prehabilitation. After surgery, the patient is transfered to an intensive care unit (not a specialized postanesthesia care unit) depending on the individual condition and then transfered to the general ward. Patients receive medical, nursing, and physiotherapeutic care in accordance with current hospital standards.
Receives: Other: Treatment as Usual

What is being measured

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

  1. Hospitalization

    number of hospitalized days due to cardiac reasons

    Measured: twelve months

  2. Six Minute Walk Test

    physical capacity expressed with the walking distance in meters

    Measured: day of discharge (approx. 5 - 10 days after operation)

Secondary outcomes (5)

  1. Goal Attainment Scale (GAS)

    level of attainment of individual goal: +2 = much more than expected, +1 = somewhat more than expected, 0 = goal achieved than expected, -1 = somewhat less than expected, -2 = much less than expected

    Measured: three months

  2. Goal Attainment Scale (GAS)

    level of attainment of individual goal: +2 = much more than expected, +1 = somewhat more than expected, 0 = goal achieved than expected, -1 = somewhat less than expected, -2 = much less than expected

    Measured: twelve months

  3. HeartQoL

    health-related quality of life; 14 items, min 0, max 42, higher scores indicating better health-related quality of life

    Measured: three months

  4. HeartQoL

    health-related quality of life; 14 items, min 0, max 42, higher scores indicating better health-related quality of life

    Measured: twelve months

  5. Costs

    direct costs in € associated with the operative procedure and the initial hospitalization using diagnosis related groups as classification system, in which diagnoses and treatments are valued according to their necessary economical expenditure

    Measured: up to 10 days

Timeline

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

  1. First posted26 Jul 2021
  2. Study start1 Jul 2021
  3. Primary completion24 Mar 2024
  4. Study completion30 Jun 2024

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized Controlled Trial
Masking
Single blind
Who is masked
Investigator
Enrolment
201 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04977362
Sponsor's protocol ID
1564/108
Acronym
INCREASE
Status last verified
Dec 2024
First submitted
18 Jun 2021
Last updated
12 Dec 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Kubitz JC, Schulte-Uentrop L, Zoellner C, Lemke M, Messner-Schmitt A, Kalbacher D, Sill B, Reichenspurner H, Koell B, Girdauskas E. Establishment of an enhanced recovery after surgery protocol in minimally invasive heart valve surgery. PLoS One. 2020 Apr 9;15(4):e0231378. doi: 10.1371/journal.pone.0231378. eCollection 2020.

    PubMed 32271849

  • Petersen J, Kloth B, Konertz J, Kubitz J, Schulte-Uentrop L, Ketels G, Reichenspurner H, Girdauskas E. Economic impact of enhanced recovery after surgery protocol in minimally invasive cardiac surgery. BMC Health Serv Res. 2021 Mar 20;21(1):254. doi: 10.1186/s12913-021-06218-5.

    PubMed 33743698

  • Klotz SGR, Ketels G, Behrendt CA, Konig HH, Kohlmann S, Lowe B, Petersen J, Stock S, Vettorazzi E, Zapf A, Zastrow I, Zollner C, Reichenspurner H, Girdauskas E. Interdisciplinary and cross-sectoral perioperative care model in cardiac surgery: implementation in the setting of minimally invasive heart valve surgery (INCREASE)-study protocol for a randomized controlled trial. Trials. 2022 Jun 23;23(1):528. doi: 10.1186/s13063-022-06455-x.

    PubMed 35739541

Questions about this trial

What is this clinical trial studying?

A study testing Enhanced Recovery After Surgery and Treatment as Usual in people with Heart Valve Diseases, run by Universitätsklinikum Hamburg-Eppendorf 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 3 inclusion and 8 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: finished, as of the sponsor's last update on 12 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 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?

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?

Hospitalization (time frame: twelve months). The study lists 2 primary outcomes in all. 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 NCT04977362, which also lists 3 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 12 Dec 2024.

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