RELieving Increasing oEdema Due to Heart Failure
- Registration Number
- NCT04142788
- Lead Sponsor
- NHS Greater Glasgow and Clyde
- Brief Summary
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.
- Detailed Description
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
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 19
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Patiromer and high dose MRA Patiromer Participants assigned to patiromer may be titrated to 200mg/day spironolactone or the highest licensed dose of eplerenone (50mg/day).
- Primary Outcome Measures
Name Time Method "Congestion Index" on Day 60 After 400 patients have been evaluated at Day 60 To find out whether administering patiromer and higher-dose MRA improves evidence of congestion on Day 60 compared to standard care.
Morbidity/Mortality Through study completion 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.
Morbidity and Mortality Periodically up to 10 years Composite of time to (re-)hospitalisation or death
- Secondary Outcome Measures
Name Time Method Dose of MRA At 6 months and 12 months Dose of MRA for all trial participants
Congestion Index Days 7 and 60 Congestion Index score for all trial participants
Days Dead or Hospitalised During the First 60 Days Through 60 days Days dead or hospitalised during the first 60 days for all trial participants
Quality of Life (EQ-5D) Days 7 and 60 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)
Quality of Life Kansas City Cardiomyopathy Questionnaire (KCCQ-12) Days 7 and 60 Quality of Life using validated KCCQ-12 questionnaire for all trial participants (score - min 0, max 100; higher means better outcome)
NYHA Class At 6 months and 12 months NYHA class (I-IV) for all trial participants
Patient Global Assessment At 6 months and 12 months Patient Global Assessment to measure quality of life for all trial participants
Reduced All-cause Mortality Through study completion, up to 5 years All-cause mortality for all trial participants
Reduced Non-cancer Mortality Through study completion, up to 5 years Non-cancer mortality for all trial participants
Reduced Cardiovascular Mortality Through study completion, up to 5 years Cardiovascular mortality for all trial participants
Reduced Mortality/Morbidity - HF/Non-cancer During first year Days lost to hospitalisation for heart failure or non-cancer deaths over 12 months for all trial participants
Reduced Mortality/Morbidity - Any During first year Days lost to any hospitalisation or any death over 12 months for all trial participants
QALY Through study completion, up to 5 years Quality adjusted life-years for duration of the trial for all trial participants
Proportion Alive and Well at 12 Months At 12 months Proportion alive and well at 12 months (well-being defined by KCCQ-12 score) for all trial participants
Dose of Oral Diuretics Other Than MRA At 6 months and 12 months Dose of oral diuretics other than MRA for all trial participants
Participant Characteristics and Assessment of Morbidity and Mortality Periodically up to 10 years Time to cardiovascular (re-)hospitalisation or non-cancer death for registry/trial participants
Participant Characteristics/Assessment of Morbidity/Mortality Periodically up to 10 years Time to heart failure (re-)hospitalisation or non-cancer death for registry/trial participants
Characteristics and Assessment of Morbidity/Mortality Periodically up to 10 years Incidence rate for hospitalisation for registry/trial participants
Characteristics/Assessment of Morbidity/Mortality Periodically up to 10 years Time to death (all-causes, cardiovascular causes, heart failure causes, cancer causes, and other) for registry and trial participants
Trial Locations
- Locations (11)
Basildon University Hospital
🇬🇧Basildon, United Kingdom
Glasgow Royal Infirmary
🇬🇧Glasgow, Strathclyde, United Kingdom
Victoria Hospital
🇬🇧Kirkcaldy, United Kingdom
Blackpool Victoria Hospital
🇬🇧Blackpool, United Kingdom
Princess of Wales Hospital
🇬🇧Bridgend, United Kingdom
Guy's and St Thomas's Hospital
🇬🇧London, United Kingdom
St George's Hospital
🇬🇧London, United Kingdom
Royal Devon and Exeter Hospital
🇬🇧Exeter, United Kingdom
Queen Elizabeth University Hospital
🇬🇧Glasgow, United Kingdom
King's College Hospital
🇬🇧London, United Kingdom
Castle Hill Hospital
🇬🇧Hull, United Kingdom