NCT02149940

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
29

participants targeted

Target at below P25 for not_applicable heart-failure

Timeline
Completed

Started Apr 2013

Shorter than P25 for not_applicable heart-failure

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

April 1, 2013

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

May 26, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 29, 2014

Completed
Last Updated

May 29, 2014

Status Verified

May 1, 2014

Enrollment Period

4 months

First QC Date

May 26, 2014

Last Update Submit

May 26, 2014

Conditions

Keywords

ElderlyFrailtyPolypharmacyMedication reviewClinical pharmacy services

Outcome Measures

Primary Outcomes (1)

  • the number of heart-failure related pharmaceutical interventions

    during hospital stay (average of 14 days)

Secondary Outcomes (2)

  • acceptance rate of the pharmaceutical interventions

    during hospital stay (average of 14 days)

  • clinical feasibility of the accepted interventions

    during hospital stay (average of 14 days)

Study Arms (1)

clinical pharmacy intervention

EXPERIMENTAL
Other: heart-failure related pharmaceutical intervention

Interventions

clinical pharmacy intervention

Eligibility Criteria

Age75 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • not Dutch speaking
  • treatment restrictions had been applied on admission

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospitals Leuven

Leuven, Flemish Brabant, 3000, Belgium

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Heart FailureFrailty

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Karolien Walgraeve, PharmD

    Universitaire Ziekenhuizen KU Leuven

    PRINCIPAL INVESTIGATOR
  • Lorenz R Van der Linden, PharmD

    Universitaire Ziekenhuizen KU Leuven

    PRINCIPAL INVESTIGATOR
  • Jos Tournoy, MD, PhD

    Universitaire Ziekenhuizen KU Leuven

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 26, 2014

First Posted

May 29, 2014

Study Start

April 1, 2013

Primary Completion

August 1, 2013

Study Completion

October 1, 2013

Last Updated

May 29, 2014

Record last verified: 2014-05

Locations