Biomarkers and Therapeutic Modelisation in Heart Failure (BIOMIC)
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|ClinicalTrials.gov 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
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 :
- 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.
- 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|
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 ClinicalTrials.gov identifier (NCT number): NCT01655134
|Contact: Patrick Rossignolfirstname.lastname@example.org|
|Contact: Faiez Zannademail@example.com|
|Nancy, France, 54500|
|Contact: Patrick Rossignol +33383157320 firstname.lastname@example.org|
|Contact: Faiez Zannad +33383157320 email@example.com|
|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|
|Study Director:||Patrick Rossignol||Brabois Hospital|