The Metabolic Road to Diastolic Heart Failure: Diastolic Heart Failure Study

NCT ID: NCT02446327

Last Updated: 2015-05-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

47 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2015-03-31

Brief Summary

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The main objective is to replicate the validation of omics biomarkers of left ventricular diastolic dysfunction in patients with metabolic syndrome.

The aim was to recruit overall 750 patients in Europe (100 for France). Currently, 625 patients were enrolled in Europe and 47 in France.

Detailed Description

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Conditions

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Diastolic Heart Failure

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Diastolic heart failure cohort

This is a prospective cohort of patients with diastolic heart failure. Blood sampling for biomarker assessment

Group Type OTHER

Blood sampling for biomarker assessment

Intervention Type OTHER

Interventions

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Blood sampling for biomarker assessment

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients 18 years of age or older
* Signs or symptoms of HF
* Able and willing to provide freely given written informed consent including analysis of genomics

Exclusion Criteria

* Patients with acute myocardial infarction
* Recent trauma or surgery (\< 3 months)
* Hemodynamically significant valvular disease
* Serious cerebrovascular disease or stroke in the last 3 months
* Chronic dialysis
* Chronic liver disease
* Chronic infectious (bacterial or viral) disease
* Any malignant concomitant diseases or a malignant disease in the last 5 years
* Systemic inflammatory diseases, such as autoimmune diseases, connective tissue diseases or collagenoses
* Pregnant women
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Central Hospital, Nancy, France

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

References

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Lagrange J, Jahangiri M PhD, Baudry G, Mercier N, Monzo L, Lamiral Z, Duarte K, Ter Maaten JM, Zannad F, Voors AA, Girerd N. Association Between Endothelial Alterations, Cardiac Function, and Outcomes From Health to Heart Failure: Insight From the STANISLAS, MEDIA-DHF, and BIOSTAT-CHF Cohorts. J Am Heart Assoc. 2025 Jun 3;14(11):e040179. doi: 10.1161/JAHA.124.040179. Epub 2025 May 29.

Reference Type DERIVED
PMID: 40439171 (View on PubMed)

Stienen S, Ferreira JP, Kobayashi M, Preud'homme G, Dobre D, Machu JL, Duarte K, Bresso E, Devignes MD, Andres NL, Girerd N, Aakhus S, Ambrosio G, Rocca HB, Fontes-Carvalho R, Fraser AG, van Heerebeek L, de Keulenaer G, Marino P, McDonald K, Mebazaa A, Papp Z, Raddino R, Tschope C, Paulus WJ, Zannad F, Rossignol P. Sex differences in circulating proteins in heart failure with preserved ejection fraction. Biol Sex Differ. 2020 Aug 24;11(1):47. doi: 10.1186/s13293-020-00322-7.

Reference Type DERIVED
PMID: 32831121 (View on PubMed)

Other Identifiers

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2012-A00097-36

Identifier Type: -

Identifier Source: org_study_id

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