Feasibility of Pharmaceutical Interventions in Elderly Heart Failure Patients. (RASP-HF)
Primary Purpose
Heart Failure
Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
heart-failure related pharmaceutical intervention
Sponsored by
About this trial
This is an interventional health services research trial for Heart Failure focused on measuring Elderly, Frailty, Polypharmacy, Medication review, Clinical pharmacy services
Eligibility Criteria
Inclusion Criteria:
- 75 years or older
- diagnosis of previous or new heart failure based on signs and symptoms as defined by the 'European Society of Cardiology guidelines on acute and chronic heart failure'
- diagnosis had to be confirmed by a recent echocardiogram
Exclusion Criteria:
- not Dutch speaking
- treatment restrictions had been applied on admission
Sites / Locations
- University Hospitals Leuven
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
clinical pharmacy intervention
Arm Description
Outcomes
Primary Outcome Measures
the number of heart-failure related pharmaceutical interventions
Secondary Outcome Measures
acceptance rate of the pharmaceutical interventions
clinical feasibility of the accepted interventions
Full Information
NCT ID
NCT02149940
First Posted
May 26, 2014
Last Updated
May 26, 2014
Sponsor
Universitaire Ziekenhuizen KU Leuven
1. Study Identification
Unique Protocol Identification Number
NCT02149940
Brief Title
Feasibility of Pharmaceutical Interventions in Elderly Heart Failure Patients.
Acronym
RASP-HF
Official Title
Feasibility of Pharmaceutical Interventions in Elderly Heart Failure Patients: a Pilot Study.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
April 2013 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
October 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universitaire Ziekenhuizen KU Leuven
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Heart failure therapies (e.g. beta blockers) have been successful in decreasing mortality rates, as well as diminishing hospitalizations. Also, pharmacist collaboration has been shown to have a beneficial impact on heart failure related outcomes. Regardless, a high residual event rate is to be noted.
In our pilot study, we wished to document whether a clinical pharmacist could still play a role in the heart failure management of an elderly inpatient heart failure population.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
Elderly, Frailty, Polypharmacy, Medication review, Clinical pharmacy services
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
29 (Actual)
8. Arms, Groups, and Interventions
Arm Title
clinical pharmacy intervention
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
heart-failure related pharmaceutical intervention
Primary Outcome Measure Information:
Title
the number of heart-failure related pharmaceutical interventions
Time Frame
during hospital stay (average of 14 days)
Secondary Outcome Measure Information:
Title
acceptance rate of the pharmaceutical interventions
Time Frame
during hospital stay (average of 14 days)
Title
clinical feasibility of the accepted interventions
Time Frame
during hospital stay (average of 14 days)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
75 years or older
diagnosis of previous or new heart failure based on signs and symptoms as defined by the 'European Society of Cardiology guidelines on acute and chronic heart failure'
diagnosis had to be confirmed by a recent echocardiogram
Exclusion Criteria:
not Dutch speaking
treatment restrictions had been applied on admission
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karolien Walgraeve, PharmD
Organizational Affiliation
Universitaire Ziekenhuizen KU Leuven
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lorenz R Van der Linden, PharmD
Organizational Affiliation
Universitaire Ziekenhuizen KU Leuven
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jos Tournoy, MD, PhD
Organizational Affiliation
Universitaire Ziekenhuizen KU Leuven
Official's Role
Study Director
Facility Information:
Facility Name
University Hospitals Leuven
City
Leuven
State/Province
Flemish Brabant
ZIP/Postal Code
3000
Country
Belgium
12. IPD Sharing Statement
Citations:
PubMed Identifier
34654283
Citation
Walgraeve K, Van der Linden L, Flamaing J, Fagard K, Spriet I, Tournoy J. Feasibility of optimizing pharmacotherapy in heart failure patients admitted to an acute geriatric ward: role of the clinical pharmacist. Eur Geriatr Med. 2018 Feb;9(1):103-111. doi: 10.1007/s41999-017-0019-x. Epub 2018 Jan 4.
Results Reference
derived
Learn more about this trial
Feasibility of Pharmaceutical Interventions in Elderly Heart Failure Patients.
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