Is There a Benefit to Optimize Heart Failure (HF) Treatment in Aged Over 80 Year's Old Patients? (HF 80)
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | August 31, 2011 | ||||
| Last Updated Date | September 19, 2011 | ||||
| Start Date ICMJE | August 2011 | ||||
| Estimated Primary Completion Date | December 2012 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Change from baseline in quality of life [ Time Frame: baseline, at 6 months ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01437371 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
|
||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Is There a Benefit to Optimize Heart Failure (HF) Treatment in Aged Over 80 Year's Old Patients? | ||||
| Official Title ICMJE | Is There a Benefit to Optimize HF (Heart Failure) Treatment in Aged Over 80 Year's Old Patients? | ||||
| 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. |
||||
| Detailed Description | Aging population, and better management of various heart diseases including ischemic explain the growing up of incidence and prevalence of chronic heart failure. The aging of the population leads now to support services in cardiology and particularly in the units of heart failure in subjects over 80 years. It's a special population with several co-morbidities, in whom it is difficult to introduce all the recommended treatments with optimal doses. There is indeed a significant difference between the optimal doses of treatments tested in studies on heart failure and doses found on the orders of inpatients for HF (heart failure). Unfortunately clinical trials on heart failure have recruited young patients, mean age 65 years. Clinical studies in cardiology and particularly in heart failure recruit young subjects at the expense of seniors who are underrepresented in these studies. The investigators will compare two groups: the first one with an "optimized" management and the second one as "usual care". The primary endpoint will evaluate the quality of life at 6 months according to the scale of Minnesota. Secondary outcomes will be the quality of life at 12 months, quality of life measured by the SF 12 (to check what level is most suited to this population) at baseline, 6 months and one year, mortality at 12 months, the number of re-hospitalization and cardiovascular events at 12 months, New York Health Association (NYHA) class (at baseline, 6 months and 12 months) and walking test for 6 minutes (at baseline, 6 months and 12 months). Finally the investigators plan to conduct an analysis on the medical and economic interest of this support. |
||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 3 | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
||||
| Condition ICMJE | Heart Failure | ||||
| Intervention ICMJE | Drug: - Angiotensin conversing enzyme inhibitors: enalapril, captopril, lisinopril, ramipril, trandolapril.
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 |
||||
| Study Arm (s) |
|
||||
| Publications * | 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. | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 80 | ||||
| Estimated Completion Date | February 2013 | ||||
| Estimated Primary Completion Date | December 2012 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||
| Gender | Both | ||||
| Ages | Not Provided | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
|
||||
| Location Countries ICMJE | France | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01437371 | ||||
| Other Study ID Numbers ICMJE | CHU-0102 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | University Hospital, Clermont-Ferrand | ||||
| Study Sponsor ICMJE | University Hospital, Clermont-Ferrand | ||||
| Collaborators ICMJE |
|
||||
| Investigators ICMJE |
|
||||
| Information Provided By | University Hospital, Clermont-Ferrand | ||||
| Verification Date | September 2011 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||