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NCT04844944: H²-Registry
The Helios Heart Registry: A Standardized Registry for Patients With Specific Cardiac Diseases
trial in Heart Failure in 24,000 participants. Currently enrolling.
1 March 2026
Quick facts
| Lead sponsor | Helios Health Institute GmbH |
|---|---|
| Status | Recruiting now |
| Study type | OBSERVATIONAL |
| Enrollment | 24,000 |
| Start date | 30 March 2021 |
| Primary completion | 1 March 2026 |
| Estimated completion | 1 March 2026 |
| Sites | 10 locations across Germany |
Conditions studied
- Heart Failure — all drugs for Heart Failure →
- Coronary Artery Disease — all drugs for Coronary Artery Disease →
- Atrial Fibrillation — all drugs for Atrial Fibrillation →
Sponsor
Helios Health Institute GmbH
Who can join
18 and older, any sex, with Heart Failure or Coronary Artery Disease. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
-
A multicentre registry of hospitalized patients with acute and chronic heart failure: Study design of the H<sup>2</sup>-registry.
Leiner J, König S, Nitsche A, Hohenstein S, et al · · 2025 · cited 4× · PMID 40222816 · DOI 10.1002/ehf2.15266 -
Patients' preferences regarding the digital capturing of patient-reported outcomes: planning the future follow-up in a prospective heart failure registry.
König S, Leiner J, Nitsche A, Mouratis K, et al · · 2021 · cited 2× · PMID 36713095 · DOI 10.1093/ehjdh/ztab074 -
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 H<sup>2</sup>-registry.
Leiner J, Hohenstein S, König S, Kwast S, et al · · 2026 · PMID 41627441 · DOI 10.1007/s00392-026-02853-2
Verify or expand the search:
- PubMed search for NCT04844944
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Heart Failure
Currently open trials in the same condition.
- NCT06118983 — Improving TRansitions ANd OutcomeS for Heart FailurE Patients in Home Health CaRe (I-TRANSFER-HF) · NA · recruiting
- NCT07496372 — Efficacy and Safety of Human Induced Pluripotent Stem Cell-Derived Cardiomyocyte Injection (HiCM-188) in Advanced Heart · Phase 3 · recruiting
- NCT07527156 — Prolonged Nasogastric Administration of Ketones in Decompensated Heart Failure · Phase 4 · recruiting
- NCT07263035 — Urine Sodium-Driven Diuretic Adjustment Strategy in Acute Decompensated Heart Failure · Phase 4 · recruiting
- NCT07531966 — Vascular Complications After Kidney Transplantation · recruiting
Other Helios Health Institute GmbH trials
Trials by the same sponsor.
- NCT05203484 — Effect of Multielectrode Versus Point-by-Point Mapping on Recurrence of Ventricular Tachycardia in Ischemic Heart Diseas · NA · suspended
- NCT05389631 — Trifecta and Epic ViV Detailed Insights Into Management Strategies and Outcomes · completed
- NCT05133843 — Complete Functional Assessment of Intermediate Coronary Artery Stenosis Before and After Transcatheter Aortic Valve Impl · NA · recruiting
- NCT04844931 — Remote Ischemic Conditioning With Local Ischemic Postconditioning in High-Risk ST-elevation Myocardial Infarction · NA · active not recruiting
- NCT05709756 — Prevalence and Predictors of Esophageal Thermal Lesions in High-power-Short-duration Ablation of Atrial Fibrillation · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04844944 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Helios Health Institute GmbH
- Last refreshed: 9 October 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04844944.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing