Primary:- To assess the prevalence of (unrecognised) HF in primary care patients with diabetes type 2. - To establish the most cost-effective diagnostic strategy to recognise HF in these patients. Secondary:- To assess the impact of heart failure,…
ID
Source
Brief title
Condition
- Heart failures
- Glucose metabolism disorders (incl diabetes mellitus)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Prevalence (with exact 95% confidence intervals) of (unrecognised) heart
failure (systolic and 'isolated' diastolic) and diagnostic value of signs and
symptoms (including co-morbidity), NT-proBNP, ECG and a combination of these
items. Moreover, the cost-effectiveness of the different diagnostic strategies.
Secondary outcome
Impact of heart failure, and the combination of diagnosis and treatment of
heart failure, on health related quality of life in patients with type 2
diabetes.
Background summary
We hypothesize that the prevalence of heart failure in patients with diabetes
type 2 aged 60 years and over is relatively high (15% or more), that most of
them will be unknown, and that a cost-effective strategy to detect unrecognised
heart failure in these patients can be developed. The strategy is expected to
include some signs and symptoms (such as laterally displaced apical beat),
B-type natriuretic peptide measurements (Amino-terminal B-type natriuretic
peptide (NT-proBNP)), and possibly electrocardiography. In a subset of patients
straightforward echocardiography may prove to be cost-effective diagnostic
screening stategy. With information from our study the detection of previously
unknown heart failure in diabetes patients can be improved, enabling the
physician to initiate beneficial morbidity and mortality reducing heart failure
treatment more timely.
Study objective
Primary:
- To assess the prevalence of (unrecognised) HF in primary care patients with
diabetes type 2.
- To establish the most cost-effective diagnostic strategy to recognise HF in
these patients.
Secondary:
- To assess the impact of heart failure, and the combination of diagnosis and
treatment of heart failure, on health related quality of life of patients with
diabetes type 2.
Study design
A prospective diagnostic efficiency study
Study burden and risks
With the answers to these questions, a substantial number of patients with
diabetes type 2 and with previously unrecognised HF can be offered morbidity
and mortality reducing treatment. The burden is a 1.5 hours lasting
standardised diagnostic assessment with history taking, physical examination,
electrocardiography, echocardiography, blood tests, and health related quality
of life questionnaires. Patients will be asked if we can contact them
afterwards for follow-up and for repeating the hRQoL questionnaires.
During the diagnostic assessment we will only use established and safe
investigations (electrocardiography and echocardiography).
Universiteitsweg 100
3508 AB Utrecht
NL
Universiteitsweg 100
3508 AB Utrecht
NL
Listed location countries
Age
Inclusion criteria
-Patients (men or women) with diabetes type 2
-Enlisted with the diabetes service of the Diagnostic Center in Etten-Leur (SHL)
-Age 60 years or older
Exclusion criteria
Those with a cardiologist-confirmed (and thus known with a) diagnosis of heart failure. The latter group will not be invited for the diagnostic assessment at the cardiology outpatient clinic, to prevent them from redundant investigations. Moreover, by adding up the prevalence of those already known with heart failure with the prevalence rate of newly detected (previously unknown) heart failure patients after the diagnostic assessment provides the overall prevalence of heart failure in patients with diabetes aged 60 years and over. Thus, the overall prevalence rate of heart failure (known plus newly detected) can be calculated without diagnostic assessment of those with diabetes already known with established heart failure. This group will be asked to answer the Quality of Life questionnairres.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL22717.041.08 |