Biomarkers and Therapeutic Modelisation in Heart Failure

Heart Failure Clinical Trial

— BIOMIC  

Official title:

Home-based Assessment of Plasma Volume, Serum Potassium and Renal Function Variations in Patients With Heart Failure and Low Left Ventricular Ejection Fraction: Pilot Study BIOMIC. Biomarkers and Therapeutic Modelisation in Heart Failure

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01655134
• Other study ID #: 2012-A00306-37
• Status: Recruiting
• Phase: N/A
• First received: July 30, 2012
• Last updated: March 20, 2014
• Start date: November 2012
• Est. completion date: March 2015

Study information

• Verified date: July 2013
• Source: Central Hospital, Nancy, France
• Contact: Patrick Rossignol
• Phone: +33383157320
• Email: p.rossignol[@]chu-nancy.fr
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial Summary

The telemonitoring systems for congestive HF did not yet prove their efficacy despite initial encouraging results. Decongestion is one of the main objectives in Congestive HF, but an appropriate titration of diuretics is warranted, since long-term use of diuretics was consistently found associated with adverse outcomes. The investigators showed (ROSSIGNOL et al., JACC 2011, Circulation 2012) that the aldosterone antagonist eplerenone has diuretic effects, as assessed by an estimated plasma volume depletion, in addition to potassium-sparing properties, independently from renal function variations. These three parameters were independently associated with patient outcomes and may therefore be potential monitoring/and therapeutic targets in patients with congestive HF.

Main objective :

To assess the variations of estimated plasma volume, serum potassium and estimated glomerular filtration rate after an hospitalization for decompensated HF, by using a home-based finger capillary punction for 5 consecutive days per week during the two months postdischarge, using an approved dedicated device (ABOTT iSTAT).

Secondary objectives :

1. to assess the correlations between plasma volume, serum potassium and estimated glomerular filtration rate variations (as measured by Istat, and by a weekly venous punction) and body weight, home blood pressure measurement, dyspnea self assessment variations.

2. bio banking (serum, plasma, urine) for further biomarker studies, one a weekly basis

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: March 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 years old or over

• Patients with heart failure and FE = 45% hospitalized for decompensated heart failure

Exclusion Criteria:

• GFR < 30 ml/min/1.73 m2 as estimated by the abbreviated MDRD formula

• Pregnancy and lactation

• Participation in other investigational trials

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Heart Failure

Intervention

Other:
• Blood simples

• Capillary punction

• Urine simples

Locations

Country	Name	City	State
France	Brabois hospital	Nancy

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France,