SMART - Systems Medicine of Heart Failure

Smart - Systems Medicine of Heart Failure

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.

Study Overview

• Status: Unknown
• Conditions: Aortic Valve Disease

• Study Type: Observational
• Enrollment (Anticipated): 60

Contacts and Locations

• Study Contact: Name: Sarah Nordmeyer, MD; Phone Number: 0049 30 45932800; Email: snordmeyer@dhzb.de

Study Locations

• Germany
  • Berlin, Germany, 13353
    • Recruiting
    • German Heart Center Berlin
    • Contact: Titus Kuehne, MD, PhD; Phone Number: 0049 30 2800; Email: titus.kuehne@dhzb.de
    • Principal Investigator: Christoph Knosalla, MD, PhD
    • Principal Investigator: Titus Kuehne, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with clinically relevant Aortic Valve Stenosis, who are scheduled for surgical Aortic Valve Replacement.

Description

Inclusion Criteria:

• Aortic Valve Stenosis

Exclusion Criteria:

• coronary heart disease

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hypertrophy	Muscle Mass and Fibrosis	3 months

Collaborators and Investigators

• Sponsor: German Heart Institute

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 2, 2015
• Primary Completion (Anticipated): February 28, 2018
• Study Completion (Anticipated): February 28, 2018

Study Registration Dates

• First Submitted: May 29, 2017
• First Submitted That Met QC Criteria: May 29, 2017
• First Posted (Actual): June 1, 2017

Study Record Updates

• Last Update Posted (Actual): June 1, 2017
• Last Update Submitted That Met QC Criteria: May 29, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Valve Diseases; Heart Failure; Aortic Valve Disease
• Other Study ID Numbers: SMART

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No