NCT04068740

Personalised Decision Support for Heart Valve Disease

Completed Last updated 28 August 2019

What this trial tests

trial testing Surgical treatment of valvular heart disease in Heart Valve Diseases in 169 participants. Completed in 31 January 2019.

Timeline

20 January 2016

Primary endpoint
31 January 2019

31 January 2019

Quick facts

Lead sponsor	German Heart Institute
Status	Completed
Study type	OBSERVATIONAL
Enrollment	169
Start date	20 January 2016
Primary completion	31 January 2019
Estimated completion	31 January 2019

Drugs / interventions tested

• Surgical treatment of valvular heart disease
• Virtual treatment

Conditions studied

• Heart Valve Diseases — all drugs for Heart Valve Diseases →

Sponsor

German Heart Institute

Who can join

18 and older, any sex, with Heart Valve Diseases. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Valvular Heart Disease currently affects 2.5% of the population, but is overwhelmingly a disease of the elderly and consequently on the rise. It is dominated by two conditions, Aortic Stenosis and Mitral Regurgitation, both of which are associated with significant morbidity and mortality, yet which pose a truly demanding challenge for treatment optimisation. By combining multiple complex modelling components, a comprehensive, clinically-compliant decision-support system will be developed to meet this challenge, by quantifying individualised disease severity and patient impairment, predicting disease progression, ranking the effectiveness of alternative candidate procedures, and optimising the patient-specific intervention plan.

In addition the DSS will improve knowledge of disease mechanisms by applying a holistic assessment of cardiovascular function that includes hemodynamic data at all cardiovascular compartments (ventricle, valve, vessels) and multiscale components that couple organ with cell function.

DSS may have major impact on patients with borderline indications for treatment (valve replacement/repair), complex hemodynamic conditions such as combined aortic-mitral valve disease and valve geometries that are subject to valve repair.

The target user of this Decision Support System is the healthcare professional, in this case the surgeon or cardiologist, who will make the decision on the nature and timing of the intervention. The major advance of this system over current practice is that it integrates and interprets all heterogeneous data available about the patient, integrates population data where needed, and provides a consistent, repeatable, quantitative and auditable record of the information that contributes to the decision process.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. CARDIOKIN1: Computational Assessment of Myocardial Metabolic Capability in Healthy Controls and Patients With Valve Diseases.
   Berndt N, Eckstein J, Wallach I, Nordmeyer S, et al · · 2021 · cited 20× · PMID 34762513 · DOI 10.1161/circulationaha.121.055646
2. Wearable devices can predict the outcome of standardized 6-minute walk tests in heart disease.
   Schubert C, Archer G, Zelis JM, Nordmeyer S, et al · · 2020 · cited 18× · PMID 32665977 · DOI 10.1038/s41746-020-0299-2
3. Disease- and sex-specific differences in patients with heart valve disease: a proteome study.
   Nordmeyer S, Kraus M, Ziehm M, Kirchner M, et al · · 2023 · cited 5× · PMID 36627164 · DOI 10.26508/lsa.202201411