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Study to analyze parameters of internal and external cardiac power, cardiac output and aortic compliance using cardiac magnet resonance imaging in patients with heart failure

Organizational Data

DRKS-ID:
DRKS00015615
Recruitment Status:
Recruiting ongoing
Date of registration in DRKS:
2018-10-22
Last update in DRKS:
2020-10-16
Registration type:
Retrospective

Acronym/abbreviation of the study

EMPATHY-HF

URL of the study

No Entry

Brief summary in lay language

EMPATHY-HF seeks to characterize heart failure patients with different ejection fractions (HFrEF, HFmrEF and HFpEF) by clinical examination, laboratory evaluation and morphologic imaging (MRI and Echocardiography) compared to healthy controls, aiming to improve understanding of different phenotypes.

Brief summary in scientific language

The objective of this study is to determine specific magnetic resonance imaging (MRI) derived parameters in patients with heart failure measured during rest and isometric physical strain (handgrip). Previous medical therapies were proven to be effective only in HFrEF and act mainly by reducing left ventricular afterload in peripheral vessels as do ACE-Inhibitors, AT1-Inhibitors etc. or by reducing cardiac preload as do diuretics. Novel, innovative therapeutic strategies include agents which act directly in the myocardium. Yet, there is a lack of validated methods to evaluate the effect of those therapeutic agents. Cardiac MRI could by quantifying cardiac power act as a method for evaluating the effect of such drugs with directly influence the myocardium. In addition, cardiac MRI serve as a superior tool for characterizing HFrEF and HFpEF. Internal and external cardiac power can assess the energetic state and capacity of the heart. Measuring aortic compliance allows vascular profiling. Hence, better understanding of pathophysiology of heart failure is expected, especially regarding the yet poorly understood HFpEF. Also, this study is meant to investigate novel means for characterizing heart failure entities for diagnostics and evaluation of therapeutic success. Internal and external cardiac power derived from measured parameters could in the future, once validated, serve es evaluation tool therapies, especially for HFpEF still lacking evidence-based therapy. Using this innovative approach to quantify cardiac power on initial diagnosis and during clinical course, meaningful insights into cardiac energetics in heart failure could be gained, leading to a more profound understanding of this disease.

Health condition or problem studied

ICD10:
I50 - Heart failure
Healthy volunteers:
No Entry

Interventions, Observational Groups

Arm 1:
Heart Failure with reduced, midrange and preserved Ejection Fraction undergoing clinical, laboratory, sonographic and MRI examination
Arm 2:
Subjects without Heart Failure undergoing clinical, laboratory, sonographic and MRI examination

Endpoints

Primary outcome:
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 outcome:
I. Measurement of endothelial function: flow measurements and area change in coronary arteries. II. Measurement of parameters of right ventricular systolic and diastolic function.

Study Design

Purpose:
Diagnostic
Retrospective/prospective:
No Entry
Study type:
Non-interventional
Longitudinal/cross-sectional:
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Study type non-interventional:
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Recruitment

Recruitment Status:
Recruiting ongoing
Reason if recruiting stopped or withdrawn:
No Entry

Recruitment Locations

Recruitment countries:
  • Germany
Number of study centers:
Monocenter study
Recruitment location(s):
  • University medical center Charité Campus Virchow Klinikum, Medizinische Klinik mit Schwerpunkt Kardiologie Berlin

Recruitment period and number of participants

Planned study start date:
No Entry
Actual study start date:
2017-04-05
Planned study completion date:
No Entry
Actual Study Completion Date:
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Target Sample Size:
90
Final Sample Size:
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Inclusion Criteria

Sex:
All
Minimum Age:
45 Years
Maximum Age:
no maximum age
Additional 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 <40% in echocardiography during screening •individualized optimized and unchanged (at least 7 days prior to screening ) heart failure therapy (must include Beta-Blocker, ACE-Inhibitor/ AT1-Inhibitor, Aldosteron-Antagonist as long as no contraindicationst) •EF <40% in imaging within 90 days of screening. Sub-group HFmrEF • EF 40-49% •NT-proBNP ≥ 220 pg/ml while in Sinus rhythm on 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 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

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 <1 year •Anemia, Hb < 10 mg/dl •Pregnant or breastfeeding women •untreated clinically significant disease of the thyroid •Additional MRI-contraindications -history of claustrophobia -history of hardness of hearing >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

Addresses

Primary Sponsor

Charité Campus Virchowklinikum Medizinische Klinik mit Schwerpunkt Kardiologie
PD Dr. med. Hans-Dirk Düngen
Augustenburger Platz 1
13353 Berlin
Germany
Telephone:
+49 450 665475
Fax:
No Entry
Contact per E-Mail
URL:
https://kardio-cvk.charite.de/
Investigator Sponsored/Initiated Trial (IST/IIT):
Yes

Contact for Scientific Queries

Charité Campus Virchowklinikum Medizinische Klinik mit Schwerpunkt Kardiologie
Djawid Hashemi
Agustenburger Platz 1
13353 Berlin
Germany
Telephone:
030 450 665475
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Contact for Public Queries

Charité Campus Virchowklinikum Medizinische Klinik mit Schwerpunkt Kardiologie
Djawid Hashemi
Augustenburger Platz 1
13353 Berlin
Germany
Telephone:
030450665475
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Principal Investigator

Charité Campus Virchowklinikum Medizinische Klinik mit Schwerpunkt Kardiologie
Djawid Hashemi
Agustenburger Platz 1
13353 Berlin
Germany
Telephone:
030 450 665475
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Sources of Monetary or Material Support

Institutional budget, no external funding (budget of sponsor/PI)

Charité Campus Virchowklinikum Medizinische Klinik mit Schwerpunkt Kardiologie
Augustenburger Platz 1
13353 Berlin
Germany
Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Institutional budget, no external funding (budget of sponsor/PI)

Deutsches Herzzentrum Berlin (DHZB) & Charité- Universitätsmedizin BerlinKlinik für Innere Medizin und Kardiologie
Augustenburger Platz 1
13353 Berlin
Germany
Telephone:
030-4593 2400
Fax:
030-4593 2500
Contact per E-Mail
URL:
https://www.dhzb.de/de/abteilungen/innere_medizin_kardiologie/

Ethics Committee

Address Ethics Committee

Ethikkommission der Charité – Universitätsmedizin Berlin
Charitéplatz 1
10117 Berlin
Germany
Telephone:
(+49)30-450517222
Fax:
(+49)30-450517952
Contact per E-Mail
URL:
No Entry

Vote of leading Ethics Committee

Date of ethics committee application:
2016-07-14
Ethics committee number:
EA4/112/16
Vote of the Ethics Committee:
Approved
Date of the vote:
2016-08-03

Further identification numbers

Other primary registry ID:
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EudraCT Number:
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UTN (Universal Trial Number):
No Entry
EUDAMED Number:
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IPD - Individual Participant Data

Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
No Entry
IPD Sharing Plan:
No Entry

Study protocol and other study documents

Study protocols:
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Study abstract:
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Other study documents:
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Background literature:
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Related DRKS studies:
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Publication of study results

Planned publication:
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Publikationen/Studienergebnisse:
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Date of first publication of study results:
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DRKS entry published for the first time with results:
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Basic reporting

Basic Reporting / Results tables:
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Brief summary of results:
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