NCT03172338

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2015

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 2, 2015

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

May 29, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 1, 2017

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2018

Completed
Last Updated

June 1, 2017

Status Verified

May 1, 2017

Enrollment Period

2.7 years

First QC Date

May 29, 2017

Last Update Submit

May 29, 2017

Conditions

Aortic Valve Disease

Outcome Measures

Primary Outcomes (1)

  • Hypertrophy

    Muscle Mass and Fibrosis

    3 months

Eligibility Criteria

Age40 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Aortic Valve Stenosis

You may not qualify if:

  • coronary heart disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

German Heart Center Berlin

Berlin, 13353, Germany

RECRUITING

Related Publications (3)

  • 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.

    PMID: 34762513DERIVED

  • 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.

    PMID: 33641670DERIVED

  • 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.

    PMID: 31131388DERIVED

MeSH Terms

Conditions

Aortic Valve Disease

Condition Hierarchy (Ancestors)

Heart Valve DiseasesHeart DiseasesCardiovascular Diseases

Central Study Contacts

Sarah Nordmeyer, MD

CONTACT

0049 30 45932800snordmeyer@dhzb.de

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
3 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 29, 2017

First Posted

June 1, 2017

Study Start

June 2, 2015

Primary Completion

February 28, 2018

Study Completion

February 28, 2018

Last Updated

June 1, 2017

Record last verified: 2017-05

Locations

DE(1)