Study information
What taking part in EXCALIBUR-HFpEF involves: the visits, the two study groups, the samples collected and how consent works.
Based on the participant information published by University Medical Center Mainz. The study follows the same protocol in Mainz and Heidelberg.
A screening visit and a 12-week study phase
Participation includes a screening visit and a 12-week intervention phase with five further visits, six visits in total.
- Visit 0 · Information and screening (about 1.5 hours)A detailed information talk with a study physician, with time for questions. After written consent, eligibility is checked and an ECG is recorded. Participants then wear a movement sensor for one week until the next visit.
- Visit 1 · Baseline examination (about 6 hours)Review of the movement data, a physical examination focused on the cardiovascular system, a cardiopulmonary exercise test on a treadmill or bicycle, and blood and urine samples. Participants receive a stool sample kit with simple instructions. Afterwards, participants are allocated to one of the two groups by chance.
- Visits 2 and 3 · Telephone check-ins (weeks 4 and 8)The study team asks about any adverse events and offers motivational counselling.
- Visit 4 · Follow-up (week 11)The movement sensor is worn again for one week. A new stool sample tube is handed out.
- Visit 5 · Final examination (about 6 hours, week 12)The baseline examinations are repeated. This visit ends study participation.
Allocation by chance
Group 1 · Comparison group
Usual medical advice on physical activity for people with heart failure.
Group 2 · Training and app-based coaching
The same advice, plus an individual training plan, a fitness wristband that shows daily steps for 12 weeks, and a smartphone with an app that gives weekly feedback on activity and recommendations for next steps.
Building a resource for future research
Blood, urine and stool samples and medical data are collected to build a biobank for future heart-failure research. Stool samples are used to analyse the gut microbiome; they can be collected at home with the study’s sample kit and, as described in its instructions, kept at room temperature for up to 60 days.
Voluntary, with clear choices
- Participation is voluntary and starts only after written consent.
- Participants can end their participation at any time, without giving reasons and without any disadvantage.
- Two further consents are optional and given separately: sharing samples or data with academic or industry research partners, and genetic or epigenetic analyses.
- The study documents were reviewed by an ethics committee and approved by the responsible data protection officers before the study started.
Two centres, one study
Mainz
Preventive Medicine, Center for Cardiology, University Medical Center Mainz, with Sports Medicine at Johannes Gutenberg University Mainz.
Heidelberg
Department of Cardiology, Angiology and Pneumology and Sports Medicine, Heidelberg University Hospital.
Funding
Carl-Zeiss-Stiftung, as part of the Multi-dimensionAI project.
Registration
German Clinical Trials Register: DRKS00039892 ↗