I50
Conditions
Interventions
Group 1: Heart Failure with reduced, midrange and preserved Ejection Fraction undergoing clinical, laboratory, sonographic and MRI examination
Group 2: Subjects without Heart Failure undergoing clinic
Sponsors
Charité Campus Virchowklinikum Medizinische Klinik mit Schwerpunkt Kardiologie
Eligibility
Sex/Gender
All
Age
45 Years to No maximum
Inclusion criteria
Inclusion criteria: •must provide written informed consent •Age >45 years •Signs and symptoms of heart failure NYHA II-IV (at least 30 days prior to screening) •in clinically stable condition defined as no i.v. therapy with diuretics or inotropics and no hospitalization within the last 7 days •unchanged medication at least 7 days prir to screening •must have health insurance (to cover treatment costs arising from incidental findings on MRI) Sub-group HFpEF: HFpEF (according to Paulus et al.) - Baseline-Echocardiography with the following findings: •Ejection Fraction (EF) =50 und •NT-proBNP = 220 pg/ml while in sinus rhythm at screening AND •LAVI (left atrialer volume index) > 34 ml/m2 OR •E/e´ > 13 (medial or lateral mitral anulus) OR •LV-Hypertophy: septal wall thickness or posterior wall thickness = 13mm Sub-group HFrEF: •EF 34 ml/m2 OR •E/e´ > 13 (medial or lateral mitral anulus) OR •LV-Hypertophy: septal wall thickness or posterior wall thickness = 13mm Sub-group healthy controls: •No clinically relevant structural heart disease •No symptoms of heart failure •No symptoms of CAD •No relevant arrhythmia •No valve defects >I° •LVEF = 55% •must provide written informed consent •Age >45 years •must have health insurance (to cover treatment costs arising from incidental findings on MRI)
Exclusion criteria
Exclusion criteria: Contractual incapacity •Atrial Fibrillation •symptomatic CAD with Angina pectoris > CCS II •recent PCI within 4 weeks or planned PCI/CABG-surgeryI •myocardial infarction within the last 3 months •stroke within the last 3 months •Relevantes valve defect > II° •hypertrophic obstructive or infiltrative cardiac disease (z.B.: HOCM, Amyloidose) •complex congenital heart defect •ongoing myokarditis •significant pulmonary disease in investigators discreation •significant arrhythmia in investigators discretion •persistent atrial fibrillation •planned changes of concomitant medication •planed heart transplantation, status post heart transplantation •Cardiac Resynchronisation Therapy (CRT) begun within last 3 months •ICD/Pacemaker implanted within last 4 weeks •Uncontrolled Hyper-/Hypotension (sysBP > 180 mmHg/ diasBP > 95mmHg) •Enrolled in rehabilitation program •known malignant disease limiting life expectancy 30 dB -history of tinnitus -implanted pump-devices -recently implanted joint prothesis -metal coils within the brain -Neurostimulators -Cochlea-Implantation -other, older ear implants -magnetically attached teeth prothesis -Metalsplinters from shells within the body -history of neurosurgery using metal clips -early pregnancy <3 months •Patients with contrast medium allergy or impaired renal function (GFR<40ml/min/1,73m²KO) •unstable cardiorespiratory state within last 4 weeks •i.v. administration of diuretics or inotropics within 7 days prior to screening •myocardial infarction within 4 days prior to inclusion
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| I Evaluation of internal and external cardiac power using cardiac MRI in patients with heart failure with reduced (HFrEF), midrange (HFmrEF) and preserved (HFpEF) ejection fraction. II. Measurement of the aortic valve pressure gradient. III. Measurement of contraction time. IV. Measurement of endsystolic and enddiastolic cardiac blood volume. V. Measurement of myocardial thickness and calculation of myocardial wall tension. VI. Measurement of myocardial wall mass and mass index. VII. Calculation of aortic compliance using pulse wave velocity and area change of aorta ascendens and descendens during systole and diastole in patients with heart failure with reduced (HFrEF), midrange (HFmrEF) and preserved (HFpEF) ejection fraction. VIII. Evaluation of cardiac output calculating the product of heart rate and stroke volume using cardiac MRI in patients with heart failure with reduced (HFrEF), midrange (HFmrEF) and preserved (HFpEF) ejection fraction. XI. Measurement of extracellular volume as a diffuse marker of fibrosis. X. Subjective description of dyspnea initially in person and during follow up in phone visits if patients consents. | — |
Secondary
| Measure | Time frame |
|---|---|
| I. Measurement of endothelial function: flow measurements and area change in coronary arteries. II. Measurement of parameters of right ventricular systolic and diastolic function. | — |
Countries
Germany
Contacts
Public ContactDjawid Hashemi
Charité Campus Virchowklinikum Medizinische Klinik mit Schwerpunkt Kardiologie
Outcome results
None listed