NCT02446327

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
47

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2012

Typical duration for not_applicable

Status
completed

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

January 1, 2012

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 14, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 18, 2015

Completed
Last Updated

May 18, 2015

Status Verified

April 1, 2015

Enrollment Period

2.2 years

First QC Date

April 14, 2015

Last Update Submit

May 13, 2015

Conditions

Diastolic Heart Failure

Outcome Measures

Primary Outcomes (1)

  • Cardiovascular Hospitalizations or Cardiovascular Death

    12 months

Secondary Outcomes (6)

  • Cardiovascular Hospitalizations

    3 months, 6 months, 12 months

  • Heart Failure Hospitalizations

    3 months, 6 months, 12 months

  • Other cardiovascular hospitalizations

    3 months, 6 months, 12 months

  • Non cardiovascular hospitalizations

    3 months, 6 months, 12 months

  • Cardiovascular Death

    3 months, 6 months, 12 months

  • +1 more secondary outcomes

Study Arms (1)

Diastolic heart failure cohort

OTHER

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

Other: Blood sampling for biomarker assessment

Interventions

Blood sampling for biomarker assessmentOTHER
Diastolic heart failure cohort

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

    PMID: 40439171DERIVED

  • 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.

    PMID: 32831121DERIVED

MeSH Terms

Conditions

Heart Failure, Diastolic

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Heart FailureHeart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 14, 2015

First Posted

May 18, 2015

Study Start

January 1, 2012

Primary Completion

March 1, 2014

Study Completion

March 1, 2015

Last Updated

May 18, 2015

Record last verified: 2015-04