Biomarkers and Therapeutic Modelisation in Heart Failure (BIOMIC)
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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 :
- 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 | 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 |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| 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
Contacts and Locations| Contact: Patrick Rossignol | +33383157320 | p.rossignol@chu-nancy.fr |
| Contact: Faiez Zannad | +33383157320 | f.zannad@chu-nancy.fr |
| 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 | |
| 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: | December 10, 2012 |
| 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 Heart Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on May 23, 2013