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

Diastolic Heart Failure Clinical Trial

— MEDIA-DHF  

Official title:

The Metabolic Road to Diastolic Heart Failure : Diastolic Heart Failure Study (MEDIA-DHF)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02446327
• Other study ID #: 2012-A00097-36
• Status: Completed
• Phase: N/A
• First received: April 14, 2015
• Last updated: May 13, 2015
• Start date: January 2012
• Est. completion date: March 2015

Study information

• Verified date: April 2015
• Source: Central Hospital, Nancy, France
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: March 2015
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Diastolic Heart Failure
• Heart Failure
• Heart Failure, Diastolic

Intervention

Other:
• Blood sampling for biomarker assessment

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiovascular Hospitalizations or Cardiovascular Death		12 months	No
Secondary	Cardiovascular Hospitalizations		3 months, 6 months, 12 months	No
Secondary	Heart Failure Hospitalizations		3 months, 6 months, 12 months	No
Secondary	Other cardiovascular hospitalizations		3 months, 6 months, 12 months	No
Secondary	Non cardiovascular hospitalizations		3 months, 6 months, 12 months	No
Secondary	Cardiovascular Death		3 months, 6 months, 12 months	No
Secondary	Non cardiovascular Death		3 months, 6 months, 12 months	No