RELieving Increasing oEdema Due to Heart Failure

Phase 4

Terminated

• Conditions: Heart Failure，Congestive
• Interventions: Drug: Patiromer

• 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

Study Timeline

• Study First Submitted: 2019-10-08
• Study First Submitted QC: 2019-10-25
• Study First Posted: 2019-10-29
• Study Start: 2020-07-28
• Primary Completion: 2022-12-20
• Study Completion: 2022-12-20
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-17
• Last Update Posted: 2023-01-19

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 4

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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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
Morbidity/mortality (trial participants)	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.
"Congestion index" on Day 60 (trial participants)	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 (registry/trial participants)	Periodically up to 10 years	Composite of time to (re-)hospitalisation or death

Secondary Outcome Measures

Name	Time	Method
Reduced mortality/morbidity	During first year	Days lost to any hospitalisation or any death over 12 months 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 MRA	At 6 months and 12 months	Dose of MRA for all trial participants
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
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
QALY	Through study completion, up to 5 years	Quality adjusted life-years for duration of the trial 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
Congestion Index	Days 7 and 60	Congestion Index score 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)
Reduced mortality	Through study completion, up to 5 years	Cardiovascular mortality for all trial participants
Participant characteristics and assessment of morbidity/mortality	Periodically up to 10 years	Time to death for registry/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