ZonMW & Heart Foundation have awarded a grant to the DVCA consortium HEART4DATA for SELEQT-HF. SELEQT-HF will be the first registry-based randomized clinical trial (RCT) in heart failure (HF) patients using the HEART4DATA infrastructure. The preparations for SELEQT-HF will start immediately under the leadership of researchers Peter van der Meer and Jeroen Schaap. They hope to show the first results within one and a half year.
SELEQT-HF is part of HEART4DATA, one of the consortium of the DCVA. The goal of the DCVA is to reduce the burden of disease for cardiac patients by 25% by 2030. To help the DCVA reach this goal, HEART4DATA aims to build a sustainable quality registry and infrastructure for registry-based research in cardiac care. This infrastructure includes all IT, legal, ethical and methodological perspectives needed to perform registry-based research.
The infrastructure not only aims to facilitate retrospective research on the data collected in the NHR-registry, but will also support randomized clinical trials (RCT). A RCT is an experiment aimed at determining efficacy of a medical treatment and uses a random selected control group. By comparing the control group with the group which received treatment, a causal relationship between an intervention and its effect on a patient characteristic can be measured. SELEQT-HF will help to demonstrate the usability and value of the infrastructure created by HEART4DATA for registry-based RCT research.
Heart failure quality registry & three research projects already initiated.
Heart failure (HF) is the first focus area of HEART4DATA. For this, the consortium is working on the creation of a sustainable heart failure quality registry. Also already three research projects are running and helping participating hospitals to collect data for this registry.
The HF quality registry is provided by the NHR (Dutch Heart Registration), who already maintains other registries in heart care as commissioned by Dutch hospitals. As with all NHR-registrations the participating hospitals will also be offered relevant mirror information for direct use. To make this new quality registration even more accepted and easy to use, attention is given within HEART4DATA to the connections with Electronic Health Records (EHR). Progress is made to embed the variable sets into the care pathways in the HER, also the extraction capabilities from the EHRs are being improved.
The first data is already collected by three observational studies: TITRATE-HF, RELEASE-HF and ENGAGE-HF. These studies use the same variables collected in the registry. By this, participating hospitals not only help these projects by collecting data, but also receive support to setup the infrastructure for the registry at their centers.
- TITRATE-HF takes a closer look at the four pillars within the guideline directed medical therapy (GDMT) of the recent ESC HF guideline. TITRATE-HF can answer questions about guideline implementation and in more detail about intolerance and reasons for failure to reach the target dose.
- RELEASE-HF examines which components of telemonitoring are and are not (cost-) effective and in which patients.
- ENGAGE-HF is aimed at heart failure nurses and deploys "gamification" and "engagement" in learning to make optimal use of quality registrations and treatment guideline implementation.
For more information on HEART4DATA and these three research projects, download the folder with the factsheets here.