RELieving Increasing oEdema Due to Heart Failure

Sponsor
NHS Greater Glasgow and Clyde
Study ID
NCT04142788
Phase
PHASE4
Status
Terminated

Conditions

  • Heart Failure，Congestive

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Patiromer — DRUG
    Patiromer (8.4g/day to 25.2g/day) and spironolactone (up to 200mg/day) or eplerenone (up to 50mg/day if spironolactone not acceptable). Treatments should be titrated to maintain serum potassium close to the target of 4.5mmol/L.

Study Details

This trial will investigate the potential for patiromer-facilitated use of higher doses of mineralocorticoid antagonists in addition to standard care (compared to standard care alone) to improve congestion, well-being and mortality in people who have worsening congestion due to heart failure and hyperkalaemia.

Key Dates

Start date
Aug 26, 2020
Status verified
Dec 2024
Primary completion
Dec 20, 2022
Completion
Dec 20, 2022

Study Design

Enrollment
19 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • No Intervention: Standard dose MRA
    Participants in this arm will have titration to guideline-recommended doses of MRA attempted.
  • Experimental: Patiromer and high dose MRA
    Participants assigned to patiromer may be titrated to 200mg/day spironolactone or the highest licensed dose of eplerenone (50mg/day).

Primary Outcome Measure

"Congestion Index" on Day 60 [ Time Frame: After 400 patients have been evaluated at Day 60 ]

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