|- candidate number||8397|
|- NTR Number||NTR2490|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||1-sep-2010|
|- Secondary IDs||2009B048 Nederlandse Hartstichting|
|- Public Title||Strategy to recognize and initiate treatment of chronic heart failure (STRETCH).|
|- Scientific Title||A combined diagnostic-therapeutic strategy to optimize management of patients with previously unrecognized heart failure in primary care.|
|- hypothesis||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.|
|- Healt Condition(s) or Problem(s) studied||Heart failure|
|- Inclusion criteria||1. Age 65 years or over;|
2. Shortness of breath as reason for GP contact in the previous 12 months.
|- Exclusion criteria||1. Already established heart failure, that is a diagnosis of heart failure confirmed by the cardiologist with echocardiography;|
2. A life expectancy shorter than 6 months;
3. Not being able to give informed consent.
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-okt-2010|
|- planned closingdate||30-mrt-2012|
|- Target number of participants||1500|
|- Interventions||Training of general practitioners in up-titration of heart failure medication. General practitioners in the intervention group will receive a single training of 2 hours from a cardiologist. The uptitrationschema of ACE-inhibitors and betablockers (based on the newest version of the NHG-standard 'Heartfailure') will be discussed and considered are the unwanted effects, interactions and contra-indications. Practical examples are being used. |
|- Primary outcome||The primary outcome of the diagnostic part of our combined diagnostic-therapeutic strategy is:|
1. Prevalence of 'systolic' and 'diastolic' heart failure in elderly who presented to the general practitioner with shortness of breath on exertion.
The primary outcomes of the therapeutic part of our combined diagnostic-therapeutic strategy are:
1. Differences in prescription of ACE-inhibitors and beta-blockers between the intervention and control group after 6 months follow-up;
2. Differences in quality of life between patients in the two groups after 6 months follow-up.
|- Secondary outcome||1. Differences in heart failure related doctor-appointments and hospitalization rates between the intervention and control group during 6 months follow-up;|
2. Cost-effectiveness of the implemented diagnostic-therapeutic strategy.
|- Timepoints||Outcomes will be meassured in two time points; in the beginning of the study and after six months of follow-up.|
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES||PhD. Evelien E.S. Riet, van|
|- CONTACT for SCIENTIFIC QUERIES|| F.H. Rutten|
|- Sponsor/Initiator ||University Medical Center Utrecht (UMCU)|
(Source(s) of Monetary or Material Support)
|Dutch Heart Foundation (Nederlandse Hartstichting)|
|- Brief summary||Background:|
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.
To determine the effect of a structured diagnostic-therapeutic strategy to detect and treat previously unrecognized or unestablished heart failure in primary care as compared to care as usual.
Combination of a diagnostic implementation study and cluster randomized trial 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 up-titration (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 up-titration 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 scruntinized to assess the (dosage of) prescribed medication.
|- Main changes (audit trail)|
|- RECORD||1-sep-2010 - 16-sep-2010|