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.
People with worsening congestive heart failure may benefit from treatment with higher doses of MRA if they are administered patiromer to treat or prevent hyperkalaemia. Potential participants with worsening heart failure will be identified by their care teams and asked to participate in a research registry. If eligible, registry participants will be asked to take part in the RELIEHF randomised trial. The randomised trial will investigate whether patiromer allows patients with worsening heart failure to be titrated to higher doses of MRA (predominantly spironolactone). Participants assigned to patiromer may be titrated to 200mg/day spironolactone or the highest licensed dose of eplerenone (50mg/day). Participants who are not assigned to patiromer should have titration to guideline-recommended doses of MRA attempted. The registry and trial will take place in about 100 secondary care sites across the UK. At the end of the trial, participants will be followed through their electronic medical records via record linkage for up to 10 years
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
19
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.
Glasgow Royal Infirmary
Glasgow, Strathclyde, United Kingdom
Basildon University Hospital
Basildon, United Kingdom
Blackpool Victoria Hospital
Blackpool, United Kingdom
"Congestion Index" on Day 60
To find out whether administering patiromer and higher-dose MRA improves evidence of congestion on Day 60 compared to standard care.
Time frame: After 400 patients have been evaluated at Day 60
Morbidity/Mortality
Composite of time to need for parenteral diuretic therapy (subsequent to initial discharge) for worsening or recalcitrant heart failure, (re-)hospitalisation for worsening heart failure or non-cancer deaths.
Time frame: Through study completion
Morbidity and Mortality
Composite of time to (re-)hospitalisation or death
Time frame: Periodically up to 10 years
Dose of MRA
Dose of MRA achieved for all trial participants
Time frame: Days 7 and 60
Congestion Index
Congestion Index score for all trial participants
Time frame: Days 7 and 60
Days Dead or Hospitalised During the First 60 Days
Days dead or hospitalised during the first 60 days for all trial participants
Time frame: Through 60 days
Quality of Life (EQ-5D)
Quality of Life using validated EQ-5D questionnaire for all trial participants (visual analogue score - min 0, max 100, higher means better outcome; calculated score min 0, max 1, higher means better outcome)
Time frame: Days 7 and 60
Quality of Life Kansas City Cardiomyopathy Questionnaire (KCCQ-12)
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Princess of Wales Hospital
Bridgend, United Kingdom
Royal Devon and Exeter Hospital
Exeter, United Kingdom
Queen Elizabeth University Hospital
Glasgow, United Kingdom
Castle Hill Hospital
Hull, United Kingdom
Victoria Hospital
Kirkcaldy, United Kingdom
Guy's and St Thomas's Hospital
London, United Kingdom
King's College Hospital
London, United Kingdom
...and 1 more locations
Quality of Life using validated KCCQ-12 questionnaire for all trial participants (score - min 0, max 100; higher means better outcome)
Time frame: Days 7 and 60
NYHA Class
NYHA class (I-IV) for all trial participants
Time frame: Days 7 and 60
Patient Global Assessment
Patient Global Assessment to measure quality of life for all trial participants (ranges from markedly improved to markedly worsened; markedly improved means a better outcome)
Time frame: Days 7 and 60
Reduced All-cause Mortality
All-cause mortality for all trial participants
Time frame: Through study completion, up to 5 years
Reduced Non-cancer Mortality
Non-cancer mortality for all trial participants
Time frame: Through study completion, up to 5 years
Reduced Cardiovascular Mortality
Cardiovascular mortality for all trial participants
Time frame: Through study completion, up to 5 years
Reduced Mortality/Morbidity - HF/Non-cancer
Days lost to hospitalisation for heart failure or non-cancer deaths over 12 months for all trial participants
Time frame: During first year
Reduced Mortality/Morbidity - Any
Days lost to any hospitalisation or any death over 12 months for all trial participants
Time frame: During first year
QALY
Quality adjusted life-years for duration of the trial for all trial participants
Time frame: Through study completion, up to 5 years
Proportion Alive and Well at 12 Months
Proportion alive and well at 12 months (well-being defined by KCCQ-12 score) for all trial participants
Time frame: At 12 months
Dose of MRA
Dose of MRA for all trial participants
Time frame: At 6 months and 12 months
Dose of Oral Diuretics Other Than MRA
Dose of oral diuretics other than MRA for all trial participants
Time frame: At 6 months and 12 months
NYHA Class
NYHA class (I-IV) for all trial participants
Time frame: At 6 months and 12 months
Patient Global Assessment
Patient Global Assessment to measure quality of life for all trial participants
Time frame: At 6 months and 12 months
Participant Characteristics and Assessment of Morbidity and Mortality
Time to cardiovascular (re-)hospitalisation or non-cancer death for registry/trial participants
Time frame: Periodically up to 10 years
Participant Characteristics/Assessment of Morbidity/Mortality
Time to heart failure (re-)hospitalisation or non-cancer death for registry/trial participants
Time frame: Periodically up to 10 years
Characteristics and Assessment of Morbidity/Mortality
Incidence rate for hospitalisation for registry/trial participants
Time frame: Periodically up to 10 years
Characteristics/Assessment of Morbidity/Mortality
Time to death (all-causes, cardiovascular causes, heart failure causes, cancer causes, and other) for registry and trial participants
Time frame: Periodically up to 10 years