NCT01202006

Brief Summary

The purpose of this study is to determine whether a structured diagnostic-therapeutic strategy to detect and treat previously unrecognized (or unestablished) heart failure in primary care will improve the functional capacity, quality of care, the quality of life, and eventually the prognosis of these patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
585

participants targeted

Target at P75+ for not_applicable heart-failure

Timeline
Completed

Started Oct 2010

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

First Submitted

Initial submission to the registry

September 14, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 15, 2010

Completed
16 days until next milestone

Study Start

First participant enrolled

October 1, 2010

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

July 8, 2015

Status Verified

July 1, 2015

Enrollment Period

2.2 years

First QC Date

September 14, 2010

Last Update Submit

July 7, 2015

Conditions

Heart Failure

Keywords

Heart failureDiagnosisTreatmentPrimary care

Outcome Measures

Primary Outcomes (5)

  • Prevalence of heart failure in elderly who presented to the general practitioner with shortness of breath on exertion.

    one year

  • Differences in walking distance between the intervention and control group.

    This outcome was added because of its relevance for patients with heart failure in April 2011. The change in study protocol was communicated to and approved by the Medical Ethics Committee of the UMC Utrecht.

    6 months

  • Differences in quality of life between the intervention and control group.

    6 months

  • Differences in prescription of heart failure medication between the intervention and control group.

    6 months

  • Differences in (heart failure related) doctor-appointments and hospitalization rates between the intervention and control group.

    6 months

Secondary Outcomes (1)

  • Cost-effectiveness of the implemented diagnostic-therapeutic strategy.

    6 months

Study Arms (2)

Intervention

EXPERIMENTAL

General practitioners of patients in the intervention group will receive detailed instructions on uptitration of ACE-inhibitors and beta-blockers before the inclusion of participants.

Other: Training of general practitioners in an uptitration protocol.

Control

NO INTERVENTION

Patients in the control group receive care-as-usual. Their general practitioner will not be trained in applying the uptitration protocol.

Interventions

Training of general practitioners in an uptitration protocol.OTHER

The general practitioners randomly allocated to the intervention group will be trained in the practical appliance of the Dutch GP's 'heart failure' guideline. They will receive detailed instructions on initiating diuretics with ACE-inhibitors and uptitration of ACE-inhibitors and beta-blockers.

Intervention

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Age 65 years or over
  • Shortness of breath as reason for GP contact in the previous 12 months

You may not qualify if:

  • Already established heart failure, that is a diagnosis of heart failure confirmed by the cardiologist with echocardiography
  • A life expectancy shorter than 6 months
  • Not being able to give informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Julius Center for Health Sciences and Primary care

Utrecht, Utrecht, 3584 CG, Netherlands

Location

Related Publications (2)

  • van Riet EE, Hoes AW, Limburg A, Landman MA, Kemperman H, Rutten FH. Extended prediction rule to optimise early detection of heart failure in older persons with non-acute shortness of breath: a cross-sectional study. BMJ Open. 2016 Feb 15;6(2):e008225. doi: 10.1136/bmjopen-2015-008225.

    PMID: 26880668DERIVED

  • van Riet EE, Hoes AW, Limburg A, van der Hoeven H, Landman MA, Rutten FH. Strategy to recognize and initiate treatment of chronic heart failure in primary care (STRETCH): a cluster randomized trial. BMC Cardiovasc Disord. 2014 Jan 8;14:1. doi: 10.1186/1471-2261-14-1.

    PMID: 24400643DERIVED

MeSH Terms

Conditions

Heart FailureDisease

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Frans H Rutten, MD, PhD

    Julius Center for Health Sciences and Primary care

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. F.H. Rutten

Study Record Dates

First Submitted

September 14, 2010

First Posted

September 15, 2010

Study Start

October 1, 2010

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

July 8, 2015

Record last verified: 2015-07

Locations

NL(1)