Preparatory Work for a Trial of Adjuncts to Diuretic Treatment in Patients Hospitalised With Heart Failure: Addressing Uncertainties and Building Consensus

NCT07281040 | Recruiting

• 1 other identifier: NIHR207987
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Aims and Objectives

1. 1.Choose which adjunctive therapies, at what dose, and for how long
2. 2.Choose the dose(s) of IV furosemide to be used as the comparator
3. 3.Choose primary and secondary outcomes
4. 4.Estimate recruitment and engage sites for a future trial
5. 5.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.
6. 6.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.
7. 7.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

Heart Failure

Outcome Measures

Primary Outcomes (2)

• Thematic Analysis of Nominal Group Discussions on Appropriate Endpoints for a Proposed Clinical Trial

  This qualitative study will use a nominal group technique to gather input from key stakeholders-including clinicians, researchers, and patient representatives-on appropriate endpoints for a proposed clinical trial. Participants will engage in structured group discussions guided by a topic guide with open-ended questions designed to prompt reflection on what makes an outcome meaningful, measurable, and feasible. Discussions will be audio-recorded, transcribed verbatim, and analyzed using thematic analysis. This process will involve inductive coding of the transcripts to identify recurring themes related to clinical relevance, patient-centeredness, feasibility, and scientific validity. After the discussions, participants will individually rank their preferred endpoints, supporting a structured consensus-building process. The combination of qualitative insights and ranked preferences will help prioritize outcomes that are both methodologically sound and aligned with stakeholder values.

  From enrollment to end of third online monthly meeting (enrollment to 3 months)

• Thematic Analysis of Nominal Group Discussions on which adjunctive therapies, at what dose, and for how long

  This qualitative outcome measure will be based on structured discussions using the nominal group technique to identify stakeholder perspectives on which adjunctive therapies should be used alongside the main intervention in a proposed clinical trial, including appropriate types, doses, and treatment durations. Participants-including clinicians, researchers, and patient representatives-will take part in guided sessions using a topic guide with open-ended questions. The discussions will be audio-recorded, transcribed verbatim, and analyzed using thematic analysis, which involves coding the data to identify key patterns and shared views. Themes will be developed around what therapies are considered beneficial, how dosing decisions should be made (e.g., based on weight, age, or clinical response), and what duration balances effectiveness with safety and feasibility. Participants will also rank their preferences after the discussion, enabling a consensus-driven prioritization of adjunctiv

  From enrollment to end of third online monthly meeting (Enrolment to month 3)

Interventions

Patient and carer panel using nominal group approach and thematic analysis OTHER

Patient and carer panel using nominal group approach and thematic analysis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

See inclusion / exclusions

You may qualify if:

• Recent hospitalisation with heart failure (\<6 months) or carer for a person with a recent hospitalisation with heart failure.
• Able to participate in online group discussions in English

You may not qualify if:

• \. Unable to participate in online group discussions in English

Sponsors & Collaborators

• Hull University Teaching Hospitals NHS Trust: lead
• Hull York Medical School: collaborator
• University of Birmingham: collaborator
• Robertson Centre for Biostatistics University of Glasgow Glasgow G12 8QQ: collaborator

Study Sites (1)

Cardiology

Hull, Yorkshire, HU16 5JQ, United Kingdom

RECRUITING

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Joe Cuthbert, MBBS MD

  Wolfson Palliative Care Research Centre, Hull York Medical School, University of Hull, Cottingham Road, Kingston-Upon-Hull, HU6 7RX

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joe Cuthbert, MBBS MD

CONTACT

+441482 875875; joe.cuthbert@hyms.ac.uk

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2025
• First Posted: December 15, 2025
• Study Start: July 2, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: December 15, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)