Biomarkers and Therapeutic Modelisation in Heart Failure

NCT ID: NCT01655134

Last Updated: 2014-03-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-11-30
• Study Completion Date: 2015-03-31

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

Conditions

Heart Failure

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Blinding Strategy: NONE

Interventions

Blood simples

Intervention Type: OTHER

Capillary punction

Intervention Type: OTHER

Urine simples

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Central Hospital, Nancy, France

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Patrick Rossignol

Role: STUDY_DIRECTOR

Brabois Hospital

Locations

Brabois hospital

Nancy, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Patrick Rossignol

Role: CONTACT

p.rossignol@chu-nancy.fr

+33383157320

Faiez Zannad

Role: CONTACT

f.zannad@chu-nancy.fr

+33383157320

Facility Contacts

Patrick Rossignol

Role: primary

p.rossignol@chu-nancy.fr

+33383157320

Faiez Zannad

Role: backup

f.zannad@chu-nancy.fr

+33383157320

References

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.

Reference Type: DERIVED

PMID: 32274878 (View on PubMed)

Other Identifiers

2012-A00306-37

Identifier Type: -

Identifier Source: org_study_id