Trials / Recruiting
RecruitingNCT04844944
The Helios Heart Registry: A Standardized Registry for Patients With Specific Cardiac Diseases
The Helios Heart Registry: A Standardized Registry for Capturing Clinical and Patient-reported Outcomes in Patients With Specific Cardiac Diseases: Application of the ICHOM Standard in Clinical Practice
- Status
- Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 24,000 (estimated)
- Sponsor
- Helios Health Institute GmbH · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
Heart failure (HF), coronary artery disease (CAD) and atrial fibrillation (AF) are among the most relevant cardiovascular diseases contributing to overall morbidity and mortality each itself and in particular in case of their coexistence. Several new therapies have been introduced in randomized controlled trials but confirmation data of treatment effects in real-world cohorts using a standardized methodology is scarce. The International Consortium for Health Outcomes Measurement (ICHOM) defined standard variable sets for all three diseases in order to objectively monitor the course of disease. To evaluate current health care utilization and interactions between diseases and treatments in patients with HF, CAD and AF as well as patient-oriented values study initiator will build a prospective, observational, multicenter cardiovascular registry using standardized patient variables and endpoints based on the ICHOM recommendations.
Conditions
Timeline
- Start date
- 2021-03-30
- Primary completion
- 2026-03-01
- Completion
- 2026-03-01
- First posted
- 2021-04-14
- Last updated
- 2024-10-09
Locations
10 sites across 1 country: Germany
Source: ClinicalTrials.gov record NCT04844944. Inclusion in this directory is not an endorsement.