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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
Universitaire Ziekenhuizen KU Leuven
About
Eligibility
Locations
Arms
Outcomes
Full info

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

75 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
May 26, 2014
Last Updated
May 26, 2014
Sponsor
Universitaire Ziekenhuizen KU Leuven
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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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