SMART - Systems Medicine of Heart Failure

NCT ID: NCT03172338

Last Updated: 2017-06-01

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-06-02
• Study Completion Date: 2018-02-28

Brief Summary

The onset and course of heart failure (HF) is triggered by a complex regulatory network that includes stressors (pressure overload by individual anatomic hemodynamic settings), intrinsic (genes), environmental (regulating epigenetics), and modifying factors (such as hor-mones and the immune system). SMART aims to establish individualized strategies for the prevention and management of HF by early detection of the physiological, genomic, proteo-mic and hemodynamic mechanisms that lead from onecommon cause of ventricular dysfunction (pressure overload) to maladaptive remodelling and irreversible HF. To cope with the complexity of HF, SMART will interrelate models describing the interplay between ge-nome, proteome and cell function, regulating hormones, tissue composition and hemody-namic whole organ function up to a whole body description of a patient and patient cohorts. The ultimate goal is to demonstrate proof-of-concept tools for predicting disease evolution and efficacy of treatment in a given patient. To achieve this task SMART will apply

• A modelling framework that couples multi-scale mechanistic models with in-depth genome/proteome, cell physiology and whole organ (biomechanical and fluid dynamic) models
• Subsequently, investigate methods validity and relevance for "quantitative prediction" of treatment outcome in a clinical proof-of-concept trial (demonstrator) of patients with aortic valve desieases.

Conditions

Aortic Valve Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• Aortic Valve Stenosis

Exclusion Criteria

• coronary heart disease

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

German Heart Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

German Heart Center Berlin

Berlin, , Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Sarah Nordmeyer, MD

Role: CONTACT

snordmeyer@dhzb.de

0049 30 45932800

Facility Contacts

Titus Kuehne, MD, PhD

Role: primary

titus.kuehne@dhzb.de

0049 30 2800

References

Berndt N, Eckstein J, Wallach I, Nordmeyer S, Kelm M, Kirchner M, Goubergrits L, Schafstedde M, Hennemuth A, Kraus M, Grune T, Mertins P, Kuehne T, Holzhutter HG. CARDIOKIN1: Computational Assessment of Myocardial Metabolic Capability in Healthy Controls and Patients With Valve Diseases. Circulation. 2021 Dec 14;144(24):1926-1939. doi: 10.1161/CIRCULATIONAHA.121.055646. Epub 2021 Nov 11.

Reference Type: DERIVED

PMID: 34762513 (View on PubMed)

Nordmeyer S, Lee CB, Goubergrits L, Knosalla C, Berger F, Falk V, Ghorbani N, Hireche-Chikaoui H, Zhu M, Kelle S, Kuehne T, Kelm M. Circulatory efficiency in patients with severe aortic valve stenosis before and after aortic valve replacement. J Cardiovasc Magn Reson. 2021 Mar 1;23(1):15. doi: 10.1186/s12968-020-00686-0.

Reference Type: DERIVED

PMID: 33641670 (View on PubMed)

Nordmeyer S, Hellmeier F, Yevtushenko P, Kelm M, Lee CB, Lehmann D, Kropf S, Berger F, Falk V, Knosalla C, Kuehne T, Goubergrits L. Abnormal aortic flow profiles persist after aortic valve replacement in the majority of patients with aortic valve disease: how model-based personalized therapy planning could improve results. A pilot study approach. Eur J Cardiothorac Surg. 2020 Jan 1;57(1):133-141. doi: 10.1093/ejcts/ezz149.

Reference Type: DERIVED

PMID: 31131388 (View on PubMed)

Other Identifiers

SMART

Identifier Type: -

Identifier Source: org_study_id