Biomarkers and Therapeutic Modelisation in Heart Failure (BIOMIC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01655134
Recruitment Status : Unknown
Verified July 2013 by Central Hospital, Nancy, France.
Recruitment status was:  Recruiting
First Posted : August 1, 2012
Last Update Posted : March 21, 2014
Information provided by (Responsible Party):
Central Hospital, Nancy, France

Brief 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

Condition or disease Intervention/treatment Phase
Heart Failure Other: Blood simples Other: Capillary punction Other: Urine simples Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
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
Study Start Date : November 2012
Estimated Primary Completion Date : January 2015
Estimated Study Completion Date : March 2015

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01655134

Contact: Patrick Rossignol +33383157320
Contact: Faiez Zannad +33383157320

Brabois hospital Recruiting
Nancy, France, 54500
Contact: Patrick Rossignol    +33383157320   
Contact: Faiez Zannad    +33383157320   
Principal Investigator: Patrick Rossignol         
Sub-Investigator: Faiez Zannad         
Sub-Investigator: Daniela Dobre         
Sub-Investigator: Jean Marc BOIVIN         
Sub-Investigator: Nicolas GIRERD         
Sub-Investigator: Arnaud OLIVIER         
Sponsors and Collaborators
Central Hospital, Nancy, France
Study Director: Patrick Rossignol Brabois Hospital

Responsible Party: Central Hospital, Nancy, France Identifier: NCT01655134     History of Changes
Other Study ID Numbers: 2012-A00306-37
First Posted: August 1, 2012    Key Record Dates
Last Update Posted: March 21, 2014
Last Verified: July 2013

Keywords provided by Central Hospital, Nancy, France:
Heart Failure
Telemonitoring systems for congestive HF

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases