Strategy to Recognize and Initiate Treatment of Chronic Heart Failure (STRETCH)

A Combined Diagnostic-therapeutic Strategy to Optimize Management of Patients With Previously Unrecognized Heart Failure in Primary Care

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.

Study Overview

• Status: Completed
• Conditions: Heart Failure
• Intervention / Treatment: Other: Training of general practitioners in an uptitration protocol.

Detailed Description

Heart failure is an emerging epidemic in especially the elderly, with high mortality rates, substantial loss in quality of life, and high healthcare costs, mainly due to hospitalizations. The majority of (usually elderly) patients with heart failure are diagnosed and managed in primary care. However underdiagnosis and undertreatment of patients with heart failure in primary care are common. Implementation of a standardized diagnostic protocol together with educating general practitioners in a pragmatic treatment strategy in which the focus lays on uptitration of heartfailure medication, would fill the gap of underdiagnosis and undertreatment that nowadays exists in primary care.

All participants will undergo a standardized diagnostic work-up to establish or rule out heart failure. In those participants with an abnormal ECG and/or elevated natriuretic peptide level additional echocardiography will be performed at the outpatient clinic of the Diakonessenhuis in Zeist. The definite diagnosis of heart failure ('systolic' or 'diastolic') will be established by an expert panel consisting of two cardiologists and a general practitioner. The panel will apply the criteria of the updated heart failure guidelines (2008) of the European Society of Cardiology (ESC). Patients with heart failure will subsequently be treated by their own general practitioner. The participating general practitioners will be randomly divided into either care as usual (control group) or special uptitration (intervention group). Both groups will be using medication as recommended in the Dutch heart failure standard. However, general practitioners in the intervention group will be especially trained in the practical appliance of this guideline: the initiation of diuretics and ACE-inhibitors and structured uptitration of ACE-inhibitors and beta-blockers. In the training, practical examples will be used concerning barriers the general practitioners themselves encountered when using this medication. In the intervention group, patients with 'systolic' heart failure will receive the recommended maximal dose or the highest tolerated dose. Patients with 'diastolic' heart failure will receive optimal blood pressure and heart rate control with the preferred cardiovascular drugs. At baseline and six months after heart failure is established or ruled out, participants are asked to perform the six-minute walk test and fill out quality of life questionnaires. During those six months, only participants with heart failure will additionally fill out one of these questionnaires every three weeks. Also after six months, electronical files of the general practitioners will be scrutinized to assess the (dosage of) prescribed medication and visits to general practice and cardiology department.

• Study Type: Interventional
• Enrollment (Actual): 585
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Utrecht, Netherlands, 3584 CG
    • Julius Center for Health Sciences and Primary Care

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; 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.; 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.
No Intervention: Control; Patients in the control group receive care-as-usual. Their general practitioner will not be trained in applying the uptitration protocol.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
Cost-effectiveness of the implemented diagnostic-therapeutic strategy.	6 months

Collaborators and Investigators

• Sponsor: UMC Utrecht
• Investigators: Principal Investigator: Frans H Rutten, MD, PhD, Julius Center for Health Sciences and Primary Care

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: October 1, 2010
• Primary Completion (Actual): December 1, 2012
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: September 14, 2010
• First Submitted That Met QC Criteria: September 14, 2010
• First Posted (Estimate): September 15, 2010

Study Record Updates

• Last Update Posted (Estimate): July 8, 2015
• Last Update Submitted That Met QC Criteria: July 7, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Keywords: Treatment; Primary care; Heart failure; Diagnosis
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: NL31024.041.10