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Biomarkers and Therapeutic Modelisation in Heart Failure

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01655134
Acronym
BIOMIC
Enrollment
20
Registered
2012-08-01
Start date
2012-11-30
Completion date
2015-03-31
Last updated
2014-03-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure

Keywords

Heart Failure, Telemonitoring systems for congestive HF, Biomarkers

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

Interventions

OTHERBlood simples
OTHERCapillary punction
OTHERUrine simples

Sponsors

Central Hospital, Nancy, France
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Countries

France

Contacts

Primary ContactPatrick Rossignol
p.rossignol@chu-nancy.fr+33383157320
Backup ContactFaiez Zannad
f.zannad@chu-nancy.fr+33383157320

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026