Preparatory Work for a Trial of Adjuncts to Diuretic Treatment in Patients Hospitalised With Heart Failure: Addressing Uncertainties and Building Consensus
NCT07281040 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 10
Last updated 2025-12-15
Summary
Aims and Objectives
1. Choose which adjunctive therapies, at what dose, and for how long
2. Choose the dose(s) of IV furosemide to be used as the comparator
3. Choose primary and secondary outcomes
4. Estimate recruitment and engage sites for a future trial
Work package 2a methods overview
1. An online survey of clinicians (doctors, nurses and pharmacists) assessing potential ability to recruit and the acceptability of each adjunct and willingness to support a trial.
2. Evidence generated (survey and reviews) will be considered by an expert panel (N=20-25) including expert clinicians and allied health professionals who care for people with HF using a modified Delphi approach. The panel will make recommendations on all aspects of the trial design.
3. A patient and carer panel of people with a recent hospitalisation (\<6 months) for HF will provide recommendations on trial endpoints. The patient-and-carer advisory group (PCAG) will also input into these discussions.
Conditions
Interventions
- OTHER
-
Patient and carer panel using nominal group approach and thematic analysis
Patient and carer panel using nominal group approach and thematic analysis
Sponsors & Collaborators
-
Hull York Medical School
collaborator UNKNOWN -
University of Birmingham
collaborator OTHER -
Robertson Centre for Biostatistics University of Glasgow Glasgow G12 8QQ
collaborator UNKNOWN -
Hull University Teaching Hospitals NHS Trust
lead OTHER_GOV
Principal Investigators
-
Joe Cuthbert, MBBS MD · Wolfson Palliative Care Research Centre, Hull York Medical School, University of Hull, Cottingham Road, Kingston-Upon-Hull, HU6 7RX
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-07-02
- Primary Completion
- 2026-10-01
- Completion
- 2026-10-01
Countries
- United Kingdom
Study Locations
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