Determination of the Prevalence of Unrecognized Heart Failure Among Patients at Risk in Urban Areas Across Germany Using CMR

NCT07185100 | Recruiting

• 1 other identifier: WE-CARE-HF-CMR
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

Brief Summary

Heart failure (HF) in patients at risk is often overlooked, and when detected, there is a lack of early and effective preventive interventions. The WE-CARE-HF-CMR study, conducted in large cities/metropol areas in Germany ( \> 1.000.000 inhabitants), aims to close this gap by evaluating the feasibility of a mobile, telemedicinemonitored HF-screening approach combining cardiac magnetic resonance imaging (CMR), quality of life assessment and laboratory tests as key elements in asymptomatic patients at risk. WE-CARE-HF-CMR will provide a proposal for a comprehensive, contemporary screening approach for patients at risk to develop HF tailored to the needs of the target population. This will provide important new information on the prevalence of asymptomatic HF in at-risk patients in urban versus rural areas. The results of the study will be compared with the results from the "HERZCheck'' trial, which provides data from approximately 4,500 participants in rural areas in Germany and has already been completed (NCT05122793).

Conditions

Heart Failure With Preserved Ejection Fraction (HFPEF); Renal Dysfunction; Stage B Heart Failure

Keywords

Prevention; Heart failure; HFpEF; Asymptomatic; Cardiology; Urban area; Germany; CMR; Cardiac Magnetic Resonance; HFrEF; Diastolic Dysfunction; Strain; mobile; GLS

Outcome Measures

Primary Outcomes (1)

• Prevalence of asymptomatic pre-heart failure (stage B) in an urban population

  Asymptomatic pre-heart failure (stage B) is defined as CMR-derived global longitudinal strain (GLS) ≥ -15%

  at baseline

Secondary Outcomes (2)

• Prevalence of chronic kidney disease (CKD)

  at baseline

• Adherence to therapy

  1, 5 years and 10 years later

Study Arms (1)

Patients at risk of heart failure

asymptomatic individuals, residing in urban areas in Germany, between the age of 40 to 69 years without known HF and at least one established cardiovascular risk factor

Eligibility Criteria

• Age: 40 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The population from which the groups or cohorts will be selected are asymptomatic adults from the urban areas of Berlin, Cologne, Frankfurt (Main), Hamburg, and Munich with no history of heart failure who have one or more risk factor for developing heart failure. They are either volunteers or referred from local cardiologists.

You may qualify if:

• Asymptomatic subjects with:
• chronic diabetes mellitus (known/diagnosed and/or antidiabetic medication and/or elevated HbA1C) and/or
• renal impairment (known/diagnosed CKD and/or in laboratory CKD III° or higher) and/or
• Hypertension (known/diagnosed and/or antihypertensive medication/treatment) and/or
• Hypercholesterolaemia (known/diagnosed and/or antilipid medication/treatment) and/or
• Obesity (known/diagnosed and/or BMI \> 30 (kg/m²)) and/or
• Smoker (known/diagnosed and/or current/previous and/or medication/treatment)
• Age 40-69 years
• female or male or diverse sex
• Ability to provide informed consent
• Provision of Informed Consent

You may not qualify if:

• Inability to provide written informed consent
• Diagnosed heart failure or previously detected reduced ejection fraction
• Haemodynamically unstable participants (heart rate \< 45/min, systolic blood pressure \< 90 mmHg)
• Claustrophobia
• Sensorineural hearing loss of 30 dB or more and tinnitus
• Acute mental disorders requiring therapy
• In the presence of pregnancy

Sponsors & Collaborators

• German Heart Institute: lead
• AstraZeneca: collaborator
• Philips Healthcare: collaborator
• Deutsches Herzzentrum der Charité, Berlin: collaborator
• German Heart Center Foundation: collaborator
• Nationale Herzallianz (NHA): collaborator
• Deutsche Herzstiftung: collaborator

Study Sites (1)

Deutsches Herzzentrum der Charité

Berlin, 13353, Germany

RECRUITING

Related Publications (14)

• Peters AE,Clare RM,Chiswell K,Felker GM,Kelsey A,Mentz R,DeVore AD

  BACKGROUND

• Heidenreich PA,Albert NM,Allen LA,Bluemke DA,Butler J,Fonarow GC,Ikonomidis JS,Khavjou O,Konstam MA,Maddox TM,Nichol G,Pham M,Piña IL,Trogdon JG,American Heart Association Advocacy Coordinating Committee,Council on Arteriosclerosis, Thrombosis and Vascular Biology,Council on Cardiovascular Radiology and Intervention,Council on Clinical Cardiology,Council on Epidemiology and Prevention,Stroke Council

  BACKGROUND

• Young KA,Scott CG,Rodeheffer RJ,Chen HH

  BACKGROUND

• Unverzagt S,Meyer G,Mittmann S,Samos FA,Unverzagt M,Prondzinsky R

  BACKGROUND

• Witt UE,Müller ML,Beyer RE,Wieditz J,Salem S,Hashemi D,Chen W,Cvetkovic M,Nolden AC,Doeblin P,Blum M,Thiede G,Huppertz A,Steen H,Remppis BA,Falk V,Friede T,Kelle S

  BACKGROUND

• NVL Chronische Herzinsuffizienz Langfassung - Version 4.0, 2023

  BACKGROUND

• Spertus JA, Jones PG, Sandhu AT, Arnold SV. Interpreting the Kansas City Cardiomyopathy Questionnaire in Clinical Trials and Clinical Care: JACC State-of-the-Art Review. J Am Coll Cardiol. 2020 Nov 17;76(20):2379-2390. doi: 10.1016/j.jacc.2020.09.542.

  PMID: 33183512 BACKGROUND

• Yang H, Negishi K, Wang Y, Nolan M, Marwick TH. Imaging-Guided Cardioprotective Treatment in a Community Elderly Population of Stage B Heart Failure. JACC Cardiovasc Imaging. 2017 Mar;10(3):217-226. doi: 10.1016/j.jcmg.2016.11.015.

  PMID: 28279368 BACKGROUND

• Whitmore K, Zhou Z, Chapman N, Huynh Q, Magnussen CG, Sharman JE, Marwick TH. Impact of Patient Visualization of Cardiovascular Images on Modification of Cardiovascular Risk Factors: Systematic Review and Meta-Analysis. JACC Cardiovasc Imaging. 2023 Aug;16(8):1069-1081. doi: 10.1016/j.jcmg.2023.03.007. Epub 2023 May 24.

  PMID: 37227327 BACKGROUND

• Hood SR, Giazzon AJ, Seamon G, Lane KA, Wang J, Eckert GJ, Tu W, Murray MD. Association Between Medication Adherence and the Outcomes of Heart Failure. Pharmacotherapy. 2018 May;38(5):539-545. doi: 10.1002/phar.2107. Epub 2018 Apr 30.

  PMID: 29600819 BACKGROUND

• Bozkurt B, Ahmad T, Alexander KM, Baker WL, Bosak K, Breathett K, Fonarow GC, Heidenreich P, Ho JE, Hsich E, Ibrahim NE, Jones LM, Khan SS, Khazanie P, Koelling T, Krumholz HM, Khush KK, Lee C, Morris AA, Page RL 2nd, Pandey A, Piano MR, Stehlik J, Stevenson LW, Teerlink JR, Vaduganathan M, Ziaeian B; Writing Committee Members. Heart Failure Epidemiology and Outcomes Statistics: A Report of the Heart Failure Society of America. J Card Fail. 2023 Oct;29(10):1412-1451. doi: 10.1016/j.cardfail.2023.07.006. Epub 2023 Sep 26. No abstract available.

  PMID: 37797885 BACKGROUND

• Haji K, Huynh Q, Wong C, Stewart S, Carrington M, Marwick TH. Improving the Characterization of Stage A and B Heart Failure by Adding Global Longitudinal Strain. JACC Cardiovasc Imaging. 2022 Aug;15(8):1380-1387. doi: 10.1016/j.jcmg.2022.03.007. Epub 2022 May 11.

  PMID: 35926896 BACKGROUND

• Potter E, Stephenson G, Harris J, Wright L, Marwick TH. Screening-guided spironolactone treatment of subclinical left ventricular dysfunction for heart failure prevention in at-risk patients. Eur J Heart Fail. 2022 Apr;24(4):620-630. doi: 10.1002/ejhf.2428. Epub 2022 Jan 27.

  PMID: 35014128 BACKGROUND

• Komajda M, Cowie MR, Tavazzi L, Ponikowski P, Anker SD, Filippatos GS; QUALIFY Investigators. Physicians' guideline adherence is associated with better prognosis in outpatients with heart failure with reduced ejection fraction: the QUALIFY international registry. Eur J Heart Fail. 2017 Nov;19(11):1414-1423. doi: 10.1002/ejhf.887. Epub 2017 Apr 30.

  PMID: 28463464 BACKGROUND

Related Links

• homepage of the trial: WE-CARE-HF-CMR

Biospecimen

Retention: SAMPLES WITH DNA

two tubes of blood

MeSH Terms

Conditions

Renal Insufficiency; Heart Failure; Sprains and Strains

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Heart Diseases; Cardiovascular Diseases; Wounds and Injuries

Study Officials

• Sebastian Kelle, Prof. Dr.

  Deutsches Herzzentrum der Charité

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Prof. Dr. Sebastian Kelle

CONTACT

+493045931182; sebastian.kelle@dhzc-charite.de

Dr. Gisela Thiede

CONTACT

+4915209192843; gisela.thiede@dhzc-charite.de

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Sebastian Kelle (MD)

Study Record Dates

• First Submitted: September 10, 2025
• First Posted: September 22, 2025
• Study Start: September 13, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2036
• Last Updated: April 1, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)