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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
F.H. Rutten, UMC Utrecht
ClinicalTrials.gov Identifier:
NCT01202006
First received: September 14, 2010
Last updated: January 14, 2013
Last verified: January 2013
History of Changes
  Purpose

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 quality of care, the quality of life, and eventually the prognosis of these patients.


Condition Intervention
Heart Failure
 Other: Training of general practitioners in an uptitration protocol.

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: A Combined Diagnostic-therapeutic Strategy to Optimize Management of Patients With Previously Unrecognized Heart Failure in Primary Care

Resource links provided by NLM:

MedlinePlus related topics: Heart Failure
U.S. FDA Resources

Further study details as provided by UMC Utrecht:

Primary Outcome Measures:
  • Prevalence of heart failure in elderly who presented to the general practitioner with shortness of breath on exertion. [ Time Frame: one year ] [ Designated as safety issue: No ]
  • Differences in prescription of heart failure medication between the intervention and control group. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Differences in quality of life between the intervention and control group. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Differences in heart failure related doctor-appointments between the intervention and control group. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Differences in heart failure related hospitalization rates between the intervention and control group. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Cost-effectiveness of the implemented diagnostic-therapeutic strategy. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 585
Study Start Date: October 2010
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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, all participants 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.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01202006

Locations
Netherlands
Julius Center for Health Sciences and Primary care
Utrecht, Netherlands, 3584 CG
Sponsors and Collaborators
UMC Utrecht
Investigators
Principal Investigator: Frans H Rutten, MD, PhD Julius Center for Health Sciences and Primary care
  More Information

No publications provided

Responsible Party: F.H. Rutten, Dr. F.H. Rutten, UMC Utrecht
ClinicalTrials.gov Identifier: NCT01202006     History of Changes
Other Study ID Numbers: NL31024.041.10
Study First Received: September 14, 2010
Last Updated: January 14, 2013
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by UMC Utrecht:
Heart failure
Diagnosis
Treatment
Primary care

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases
Angiotensin-Converting Enzyme Inhibitors
 Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013