Strategy to Recognize and Initiate Treatment of Chronic Heart Failure

Heart Failure Clinical Trial

— STRETCH  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01202006
• Other study ID #: NL31024.041.10
• Status: Completed
• Phase: N/A
• First received: September 14, 2010
• Last updated: July 7, 2015
• Start date: October 2010
• Est. completion date: December 2012

Study information

• Verified date: July 2015
• Source: UMC Utrecht
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 585
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Heart Failure

Intervention

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.

Locations

Country	Name	City	State
Netherlands	Julius Center for Health Sciences and Primary care	Utrecht

Sponsors (1)

Lead Sponsor	Collaborator
UMC Utrecht

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of heart failure in elderly who presented to the general practitioner with shortness of breath on exertion.		one year	No
Primary	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	No
Primary	Differences in quality of life between the intervention and control group.		6 months	No
Primary	Differences in prescription of heart failure medication between the intervention and control group.		6 months	No
Primary	Differences in (heart failure related) doctor-appointments and hospitalization rates between the intervention and control group.		6 months	No
Secondary	Cost-effectiveness of the implemented diagnostic-therapeutic strategy.		6 months	No