RecruitingNCT07281040

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

Preparatory Work for a Multi-arm, Multi-stage Trial of Adjunctive Treatments in Patients Hospitalised With Heart Failure (Pre-MAMMOTH-HF)


Sponsor

Hull University Teaching Hospitals NHS Trust

Enrollment

10 participants

Start Date

Jul 2, 2025

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria2

  • 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

Exclusion Criteria1

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

Interventions

OTHERPatient and carer panel using nominal group approach and thematic analysis

Patient and carer panel using nominal group approach and thematic analysis


Locations(1)

Cardiology

Hull, Yorkshire, United Kingdom

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NCT07281040


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