Biomarkers and Therapeutic Modelisation in Heart Failure
BIOMIC
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
1 other identifier
interventional
20
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable heart-failure
Started Nov 2012
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 30, 2012
CompletedFirst Posted
Study publicly available on registry
August 1, 2012
CompletedStudy Start
First participant enrolled
November 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2015
CompletedMarch 21, 2014
July 1, 2013
2.2 years
July 30, 2012
March 20, 2014
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- years old or over
- Patients with heart failure and FE ≤ 45% hospitalized for decompensated heart failure
You may not qualify if:
- GFR \< 30 ml/min/1.73 m2 as estimated by the abbreviated MDRD formula
- Pregnancy and lactation
- Participation in other investigational trials
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Brabois hospital
Nancy, 54500, France
Related Publications (1)
Rossignol P, Fay R, Girerd N, Zannad F. Daily home monitoring of potassium, creatinine, and estimated plasma volume in heart failure post-discharge. ESC Heart Fail. 2020 Jun;7(3):1257-1263. doi: 10.1002/ehf2.12642. Epub 2020 Apr 10.
PMID: 32274878DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Patrick Rossignol
Brabois Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 30, 2012
First Posted
August 1, 2012
Study Start
November 1, 2012
Primary Completion
January 1, 2015
Study Completion
March 1, 2015
Last Updated
March 21, 2014
Record last verified: 2013-07