Early detection of diastolic dysfunction and heart failure with preserved ejection fractio

Recruiting

• Conditions: Heart failure with preserved ejection fraction; 10010394; 10018424; 10047066

• Registration Number: NL-OMON55962
• Lead Sponsor: Vrije Universiteit Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 900

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.

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Heart failure with preserved ejectionf fraction based on echocardiographic<br /><br>measurements, clinical measurements and biomarkers. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>-</p><br>