Which markers and which vascular calcifications can be used as diagnostic markers in the dectecion of heart failure with preserved ejection fraction and diastolic dysfunction.
ID
Source
Brief title
Condition
- Congenital cardiac disorders
- Glucose metabolism disorders (incl diabetes mellitus)
- Vascular disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Heart failure with preserved ejectionf fraction based on echocardiographic
measurements, clinical measurements and biomarkers.
Secondary outcome
-
Background summary
Approximately 70% of people with type 2 diabetes develop a specific form of
heart failure, namely heart failure with preserved ejection fraction. This type
of heart failure results in relaxation problems of the heart, in which the
blood cannot be pumped to the heart in a proper way.
Heart failure with preserved ejection fraction is hard to detect. Differences
in size, shape and function of the heart are found in people with type 2
diabetes. The detection of these changes can help to diagnose these people with
a high risk of heart failure with preserved ejection fraction, so we can treat
these people properly.
Study objective
Which markers and which vascular calcifications can be used as diagnostic
markers in the dectecion of heart failure with preserved ejection fraction and
diastolic dysfunction.
Study design
Cross-sectional observational study. 250 participants from the Early-HFpEF
study will be invited after three years for a follow-up study visit.
Study burden and risks
The duration of the visit will last 2.5 - 3 hours and will take place in two
seperate study visits;
removal of the electrodes of the echocardiography can hurt a little; a chance
of bruising as a result of the venapuncture.
The CT-scan will not cause any pain in the study participants and has no direct
side effects. However, the X-rays can have long-term risks. It is known that
there is an increased risk of developing cancer when exposed to X-rays. The
dose in this study is very low; therefore the risk is negligibly small.
The additional measurements for the microvascular endothelial function, which
will be executed in a subgroup of 150 participants, can give some
minor erythema, edema or redness of the skin, due to the application of a
vasoactive solution on the skin.
de Boelelaan 1089a
Amsterdam 1081HV
NL
de Boelelaan 1089a
Amsterdam 1081HV
NL
Listed location countries
Age
Inclusion criteria
Males and females aged 50-75 years;
duration of T2DM of at least 1 year (defined on the basis of previous diagnosis
and/or treatment with hypoglycaemic agents);
with informed consent to be contacted for future research;
able to provide a written consent form.
Exclusion criteria
1. Advanced diabetes complications (like proliferative retinopathy, disabling
polyneuropathy, or stages IV-V diabetic nephropathy). 2. Cardiac comorbidity:
a) Valvular heart disease requiring surgery or intervention, or within 3 months
after valvular surgery or intervention. b) Hypertrophic obstructive
cardiomyopathy. c) Acute myocarditis, sarcoidosis, amyloidosis, Takotsubo
cardiomyopathy. d) Post-heart transplant cardiomyopathy. e) Chronic HFrEF (a LV
EF of < 50% assessed within 12 months prior to randomization). f) Clinical
diagnosis of HFpEF. g) Tachycardia-induced cardiomyopathy and/or uncontrolled
tachyarrhythmia. h) Acute coronary syndrome (unstable angina, non-ST elevation
myocardial infarction [NSTEMI]or ST elevation myocardial infarction [STEMI]) or
coronary revascularization (coronary artery bypass grafting [CABG] or
percutaneous coronary intervention [PCI]) within 60 days prior to the
enrolment, or indication for coronary revascularization at time of enrolment.
i) Symptomatic carotid stenosis, transient ischemic attack (TIA) or stroke
within 60 days prior to randomization. j) Congenital heart disease. k) Active
endocarditis or constrictive pericarditis. 3. Non-cardiac comorbidity a)
Estimated glomerular filtration rate (eGFR) calculated based on the
Modification of Diet in Renal Disease (MDRD) equation <15 mL/min/1.73 m2 or
chronic dialysis. b) Severe hepatic insufficiency. c) Malignancy or other
non-cardiac condition limiting life expectancy to < 3 years. d) e) Mental or
legal incapacitation and is unable to provide informed consent. 4.
Participation in the LIDDIA or intervention part of the PRIORITY study.
Additionally, participants implanted with internal cardiac pacemakers will be
excluded from participation to the additional LASCA measurements.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL64774.029.18 |
| OMON | NL-OMON21126 |