NCT01437371

Brief Summary

The purpose of this study is to determine if there is an interest to optimize HF (heart failure) management in patients over 80 years old. The primary objective is to assess the effect of HF (heart failure) optimized management (guidelines of the European society of Cardiology (ESC) on Quality of Life (QOL) in aged over 80 year's old at 6 months.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at below P25 for phase_3 heart-failure

Timeline
Completed

Started Aug 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 31, 2011

Completed
20 days until next milestone

First Posted

Study publicly available on registry

September 20, 2011

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

October 1, 2014

Status Verified

September 1, 2014

Enrollment Period

2.8 years

First QC Date

August 31, 2011

Last Update Submit

September 30, 2014

Conditions

Heart Failure

Keywords

Heart failureAged and over 80clinical trialquality of life

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in quality of life

    baseline, at 6 months

Secondary Outcomes (5)

  • Mortality

    at 12 months

  • Rehospitalisation

    at 12 months

  • Cardiovascular events

    at 12 months

  • Cardiac fibrosis

    at 12 months

  • Quality of life

    at 12 months

Study Arms (2)

optimized

OTHER

The purpose of this study is to determine if there is an interest to optimize HF management in patients over 80 years old. The primary objective is to assess the effect of HF optimized management (guidelines of the European society of Cardiology (ESC) on QOL in aged over 80 year's old at 6 months

Drug: - Angiotensin conversing enzyme inhibitors: enalapril, captopril, lisinopril, ramipril, trandolapril.

usual care

OTHER
Drug: - Angiotensin conversing enzyme inhibitors: enalapril, captopril, lisinopril, ramipril, trandolapril.

Interventions

- Angiotensin conversing enzyme inhibitors: enalapril, captopril, lisinopril, ramipril, trandolapril.DRUG

The purpose of this study is to determine if there is an interest to optimize HF management in patients over 80 years old. The primary objective is to assess the effect of HF optimized management (guidelines of the European society of Cardiology (ESC) on QOL in aged over 80 year's old at 6 months

optimizedusual care

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Aged over 80 year's old subjects
  • Hospitalized for an acute heart failure
  • Left Ventricle Ejection Fraction ≤ 35%
  • Evaluated life expectancy (Seattle HF score) \> 1 year

You may not qualify if:

  • Dementia
  • Does not understand French language
  • Followed with an optimized management
  • With reduced mobility
  • Recruited in another clinical trial or in a HF management network
  • AHF with curable aetiology : cardiovascular surgery for CABG or valvular replacement, angioplasty
  • MDRD \< 30 ml/min/1.73m²

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Clermont-Ferrand

Clermont-Ferrand, 63003, France

Location

Related Publications (1)

  • Eschalier R, Jean F, Pereira B, Monzy S, Vorilhon C, Mactoux V, Citron B, Sapin V, Motreff P, Lusson JR. Is there benefit in optimising heart failure treatment in over-80 year-old patients? (HF-80 study): study protocol for a randomized controlled trial. Trials. 2012 Mar 6;13:25. doi: 10.1186/1745-6215-13-25.

    PMID: 22394464DERIVED

MeSH Terms

Conditions

Heart Failure

Interventions

CaptoprilLisinoprilRamipriltrandolapril

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

ProlineImino AcidsAmino Acids, CyclicAmino AcidsAmino Acids, Peptides, and ProteinsDipeptidesOligopeptidesPeptidesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Romain ESCHALIER

    University Hospital, Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 31, 2011

First Posted

September 20, 2011

Study Start

August 1, 2011

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

October 1, 2014

Record last verified: 2014-09

Locations

FR(1)