Heart FailureRASP-HFNCT02149940
Feasibility of Pharmaceutical Interventions in Elderly Heart Failure Patients.
A study testing heart-failure related pharmaceutical intervention in people with Heart Failure, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- heart-failure related pharmaceutical intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteBelgium
- Study dates
- Apr 2013to Oct 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- not Dutch speaking
- treatment restrictions had been applied on admission
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility of Pharmaceutical Interventions in Elderly Heart Failure Patients: a Pilot Study.
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.
- Conditions
- Heart Failure
- Being tested
- heart-failure related pharmaceutical intervention
- Keywords
- Elderly, Frailty, Polypharmacy, Medication review, Clinical pharmacy services
- Medical subject headings
- Heart Failure, Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
heart-failure related pharmaceutical interventionOther
| Study group | Role | What they receive |
|---|---|---|
| clinical pharmacy intervention | Experimental | Not described Receives: Other: heart-failure related pharmaceutical intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
the number of heart-failure related pharmaceutical interventions
Measured: during hospital stay (average of 14 days)
Secondary outcomes (2)
acceptance rate of the pharmaceutical interventions
Measured: during hospital stay (average of 14 days)
clinical feasibility of the accepted interventions
Measured: during hospital stay (average of 14 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2014 (estimated)
- Study startApr 2013
- Primary completionAug 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Karolien Walgraeve, PharmD, Principal investigator, Universitaire Ziekenhuizen KU LeuvenLorenz R Van der Linden, PharmD, Principal investigator, Universitaire Ziekenhuizen KU LeuvenJos Tournoy, MD, PhD, Study director, Universitaire Ziekenhuizen KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02149940
- Sponsor's protocol ID
- S55301
- Acronym
- RASP-HF
- Status last verified
- May 2014
- First submitted
- 26 May 2014
- Last updated
- 29 May 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 34654283
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Pharmaceutical Interventions in Elderly Heart Failure Patients: a Pilot Study.
- ClinicalTrials.gov ID
- NCT02149940
- Acronym / sponsor ID
- RASP-HF / S55301
- Conditions
- Heart Failure
- Keywords
- Elderly, Frailty, Polypharmacy, Medication review, Clinical pharmacy services
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Aug 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 29 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| clinical pharmacy intervention | Experimental | Other: heart-failure related pharmaceutical intervention |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- not Dutch speaking
- treatment restrictions had been applied on admission
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| heart-failure related pharmaceutical intervention | Other | clinical pharmacy intervention |
Primary outcome
the number of heart-failure related pharmaceutical interventions
Time frame: during hospital stay (average of 14 days)
2 secondary outcomes
acceptance rate of the pharmaceutical interventions
Time frame: during hospital stay (average of 14 days)
clinical feasibility of the accepted interventions
Time frame: during hospital stay (average of 14 days)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2014.
- Derived from this study: PubMed 34654283Walgraeve 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karolien Walgraeve, PharmD principal investigator
Universitaire Ziekenhuizen KU Leuven
Lorenz R Van der Linden, PharmD principal investigator
Universitaire Ziekenhuizen KU Leuven
Jos Tournoy, MD, PhD study director
Universitaire Ziekenhuizen KU Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing heart-failure related pharmaceutical intervention in people with Heart Failure, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the number of heart-failure related pharmaceutical interventions (time frame: during hospital stay (average of 14 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02149940, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2014.