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

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ClinicalTrials.gov Identifier: NCT01202006
Recruitment Status : Completed
First Posted : September 15, 2010
Last Update Posted : July 8, 2015
Sponsor:
Information provided by (Responsible Party):
F.H. Rutten, UMC Utrecht

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.

Condition or disease Intervention/treatment
Heart Failure 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  (Clinical Trial)
Actual Enrollment : 585 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Combined Diagnostic-therapeutic Strategy to Optimize Management of Patients With Previously Unrecognized Heart Failure in Primary Care
Study Start Date : October 2010
Primary Completion Date : December 2012
Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

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

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.



Primary Outcome Measures :
  1. Prevalence of heart failure in elderly who presented to the general practitioner with shortness of breath on exertion. [ Time Frame: one year ]
  2. Differences in walking distance between the intervention and control group. [ Time Frame: 6 months ]
    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.

  3. Differences in quality of life between the intervention and control group. [ Time Frame: 6 months ]
  4. Differences in prescription of heart failure medication between the intervention and control group. [ Time Frame: 6 months ]
  5. Differences in (heart failure related) doctor-appointments and hospitalization rates between the intervention and control group. [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Cost-effectiveness of the implemented diagnostic-therapeutic strategy. [ Time Frame: 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
First Posted: September 15, 2010    Key Record Dates
Last Update Posted: July 8, 2015
Last Verified: July 2015

Keywords provided by F.H. Rutten, UMC Utrecht:
Heart failure
Diagnosis
Treatment
Primary care

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases