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Biomarkers and Therapeutic Modelisation in Heart Failure (BIOMIC)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by Central Hospital, Nancy, France
Sponsor:
Information provided by (Responsible Party):
Central Hospital, Nancy, France
ClinicalTrials.gov Identifier:
NCT01655134
First received: July 30, 2012
Last updated: March 20, 2014
Last verified: July 2013
  Purpose

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 Intervention
Heart Failure
Other: Blood simples
Other: Capillary punction
Other: Urine simples

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Central Hospital, Nancy, France:

Estimated Enrollment: 20
Study Start Date: November 2012
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01655134

Contacts
Contact: Patrick Rossignol +33383157320 p.rossignol@chu-nancy.fr
Contact: Faiez Zannad +33383157320 f.zannad@chu-nancy.fr

Locations
France
Brabois hospital Recruiting
Nancy, France, 54500
Contact: Patrick Rossignol    +33383157320    p.rossignol@chu-nancy.fr   
Contact: Faiez Zannad    +33383157320    f.zannad@chu-nancy.fr   
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
Investigators
Study Director: Patrick Rossignol Brabois Hospital
  More Information

No publications provided

Responsible Party: Central Hospital, Nancy, France
ClinicalTrials.gov Identifier: NCT01655134     History of Changes
Other Study ID Numbers: 2012-A00306-37
Study First Received: July 30, 2012
Last Updated: March 20, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

Additional relevant MeSH terms:
Heart Failure
Cardiovascular Diseases
Heart Diseases

ClinicalTrials.gov processed this record on November 25, 2014