I50
Conditions
Interventions
Group 1: Participants with heart failure with preserved or mildly reduced ejection fraction
Group 2: Participants without heart failure with preserved or mildly reduced ejection fraction and and least
Sponsors
Universitätsmedizin Greifswald
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Study group: -Left ventricular ejection fraction with LVEF >40% -heart failure symptoms NYHA= II AND left ventricular diastolic dysfunction / raised filling indices according to current AHA-recommendation (Nagueh et al 2025) - stepwise diagnostic procedure - STEP1 (diminished LV Relaxation) : e´septal =6,5 cm/s - STEP2 (LA/LV remodeling and raised LA-pressure E/e´mean>14, LARS =2, LAVI > 34 ml/m2 (except in athletes, anemia, atrial fibrillation/ atrial flutter or mitral valve disease) - LV mass index >95 g/m2 in women or 115 g/m2 in men - Characterisation as diastolic dysfunktion if a) STEP1 is present AND at least 1 finding in STEP2 OR b) STEP1 not present but >=2 findings of STEP2 present - optional an exercise stress echocardiography can be performed if dyspnea ist present an unclear left ventricular filling pressure (inclusion if E/e´ ratio mean >=14 (or E/e´septal >=15) and peak TR velocity >=3,2 m/s during or 1-2 minutes after exercise -stable medication for at least 4 weeks prior to inclusion (antihypertensive medication, diuretics, statins) -written informed consent Comparison group: -at least one cardiovascular risk factor (hypertension, type II diabetes without insulin therapy, chronic obstructive lung disease, chronic kidney disease without dialyis, BMI 27kg/m2 -normal systolic and diastolic left ventricular function in echocardiogram -normal ankle-brachial-index -exclusion of atherosclerotic plaques in duplex ultrasound of carotid artery -stable medication for at least 4 weeks prior to inclusion (antihypertensive medication, diuretics, statins) -written informed consent
Exclusion criteria
Exclusion criteria: -acute cardiac decompensation in the last 4 weeks prior to inclusion -active infectious disease in the last 4 weeks prior to inclusion -myocardial infarction (STEMI or NSTEMI) in the past 2 months -cardiac surgery oder cardiac intervention in the past 2 months -other major surgery in the past 2 months -percardial disease (if hemodynamic relevant) -recovered LVEF after previous reduced ejection fraction (HFrEF) -known cardiomyopathy -severe valvular heart disease with planned intervention -severe pulmonary hypertension -pregnancy -study visit after one year not feasible -active cancer for subgroup MRI: -common contraindications for MRI (not-MRI-suitable implants, claustrophobia, severe renal function impairment [eGFR <30 ml/min/1.73m2]) -study specific contraindications for MRI: permanent atrial fibrillation, implanted pacemaker/ defibrillator for eye examination: -common contraindiction for the use of mydriatic drug (narrow angle glaucoma)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Aim of this cohort study is to identify subgroups of patients with heart failure with preserved or mildly reduced ejection fraction (HFpEF/ HFmrEF) to allow a better characterisation of the disease and develop individualized therapeutic concepts that can be evaluated in pilot studies. A comparison group will be recruited with participants that show risk factors for cardiovascular disease but have no heart failure manifestation. | — |
Countries
Germany
Contacts
Public ContactKristin Lehnert
Klinik und Poliklinik für Innere Medizin B
Outcome results
None listed