The Helios Heart Registry: A Standardized Registry for Patients With Specific Cardiac Diseases

NCT04844944 | Recruiting DMC

• 1 other identifier: 2021-0016
• Study Type: observational
• Target: 24,000
• Locations: 1 country
• Sites: 10

Brief Summary

Investigator-initiated, prospective, non-randomized, open label, non-interventional multicenter registry to evaluate current treatment of three major cardiovascular disease entities in clinical practice using a standardized variable-set of relevant covariates and outcome measures.

Conditions

Heart Failure; Coronary Artery Disease; Atrial Fibrillation

Keywords

cardiovascular disease; HF; CAD; AF; ICHOM

Outcome Measures

Primary Outcomes (3)

• All-cause mortality during f/u

  6 months

• All-cause mortality during f/u

  12 months

• All-cause mortality during f/u

  18 months

Secondary Outcomes (44)

• in-hospital mortality

  3 days

• cardiovascular mortality during f/u

  6 months

• cardiovascular mortality during f/u

  12 months

• cardiovascular mortality during f/u

  18 months

• length of hospital stay

  3 days

Study Arms (3)

Heart Failure

Hospitalized patients diagnosed with Heart Failure. No Intervention.

Coronary Artery Disease

Hospitalized patients diagnosed with Coronary Artery Disease. No Intervention.

Atrial Fibrillation

Hospitalized patients diagnosed with Atrial Fibrillation. No Intervention.

Eligibility Criteria

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

Study Population

Patients being admitted as inpatients to a cardiology ward of one of the participating centers with one or more major cardiovascular disease entities (HF, CAD, AF)

You may qualify if:

• Age of 18 years or older
• Inpatient Treatment
• Present diagnosis of at least one of the three cardiovascular disease entities of interest according to the current guidelines of the European Society of Cardiology (ESC): HF, CAD, AF

You may not qualify if:

• Inability to provide informed consent
• Initial presentation (index hospitalization) in cardiogenic shock or other kinds of shock
• Patient after heart transplantation or patient with present ventricular assist device (VAD)

Sponsors & Collaborators

• Helios Health Institute GmbH: lead

Study Sites (10)

Helios Klinikum Berlin-Buch

Berlin, 13125, Germany

ACTIVE NOT RECRUITING

Helios Klinikum Erfurt

Erfurt, 99089, Germany

ACTIVE NOT RECRUITING

Helios Klinikum Gifhorn

Gifhorn, 38518, Germany

ACTIVE NOT RECRUITING

Helios Klinikum Hildesheim

Hildesheim, 31135, Germany

RECRUITING

Heart Center Leipzig at University of Leipzig

Leipzig, 04289, Germany

ACTIVE NOT RECRUITING

Helios Vogtlandklinikum Plauen

Plauen, 08529, Germany

ACTIVE NOT RECRUITING

Helios Klinikum Schwerin

Schwerin, 19049, Germany

RECRUITING

Helios Klinikum Siegburg

Siegburg, 53721, Germany

ACTIVE NOT RECRUITING

Helios Dr. Horst Schmidt Kliniken Wiesbaden

Wiesbaden, 65199, Germany

RECRUITING

Helios Universitätsklinikum Wuppertal

Wuppertal, 42283, Germany

RECRUITING

Related Publications (2)

• Leiner J, Hohenstein S, Konig S, Kwast S, Nitsche A, Seyfarth M, Baberg H, Lauten A, Neuser H, Staudt A, Tebbenjohanns J, Andrie R, Niehaus M, Ferrari MW, Muller M, Schulte N, Bode K, Kuhlen R, Bollmann A. Characteristics and outcomes of patients with heart failure and reduced left ventricular ejection fraction in relation to sodium-glucose cotransporter-2 inhibitor treatment: real-world data from the multicentre H2-registry. Clin Res Cardiol. 2026 Feb 2. doi: 10.1007/s00392-026-02853-2. Online ahead of print.

  PMID: 41627441 DERIVED

• Leiner J, Konig S, Nitsche A, Hohenstein S, Nagel J, Seyfarth M, Baberg H, Lauten A, Neuser H, Staudt A, Tebbenjohanns J, Andrie R, Niehaus M, Ferrari MW, Kuhlen R, Bollmann A. A multicentre registry of hospitalized patients with acute and chronic heart failure: Study design of the H2-registry. ESC Heart Fail. 2025 Aug;12(4):3114-3133. doi: 10.1002/ehf2.15266. Epub 2025 Apr 13.

  PMID: 40222816 DERIVED

MeSH Terms

Conditions

Heart Failure; Coronary Artery Disease; Atrial Fibrillation; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Heart Diseases; Coronary Disease; Myocardial Ischemia; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Arrhythmias, Cardiac; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Andreas Bollmann, MD, PhD

  Heart Center at University of Leipzig

  STUDY CHAIR

Central Study Contacts

Andreas Bollmann, MD, PhD

CONTACT

+49 341 865-1413; Andreas.bollmann@helios-gesundheit.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2021
• First Posted: April 14, 2021
• Study Start: March 30, 2021
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: October 9, 2024

Record last verified: 2024-10

Locations

DE (10)