RELieving Increasing oEdema Due to Heart Failure

NCT04142788 | Terminated Phase 4 Results DMC

• 2 other identifiers: GN17CA0822018-003662-14
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 11

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.

Conditions

Heart Failure，Congestive

Outcome Measures

Primary Outcomes (3)

• "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.

  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.

  Through study completion

• Morbidity and Mortality

  Composite of time to (re-)hospitalisation or death

  Periodically up to 10 years

Secondary Outcomes (22)

• Dose of MRA

  Days 7 and 60

• Congestion Index

  Days 7 and 60

• Days Dead or Hospitalised During the First 60 Days

  Through 60 days

• Quality of Life (EQ-5D)

  Days 7 and 60

• Quality of Life Kansas City Cardiomyopathy Questionnaire (KCCQ-12)

  Days 7 and 60

Study Arms (2)

Standard dose MRA

NO INTERVENTION

Participants in this arm will have titration to guideline-recommended doses of MRA attempted.

Patiromer and high dose MRA

EXPERIMENTAL

Participants assigned to patiromer may be titrated to 200mg/day spironolactone or the highest licensed dose of eplerenone (50mg/day).

Drug: Patiromer

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.

Also known as: Veltassa

Patiromer and high dose MRA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A. For the Screening Log (no follow-up envisaged nor linkage to electronic medical records)
• ≥18 years
• Heart failure in the investigators opinion (new onset or decompensated chronic heart failure)
• Planned to receive\>80mg/day of furosemide or equivalent (IV, SC or oral) in the next 24 hours.
• Worsening symptoms \& signs of congestion in the prior 10 days requiring at least one of the following:
• hospitalisation
• administration of intravenous diuretics
• an increase in the dose of loop diuretic by at least 40mg/day of furosemide (or equivalent) to a total of at least 80mg/day of furosemide (or equivalent)
• addition of a thiazide diuretic to treatment with a loop diuretic
• B. For the Consented Registry (with linkage to electronic medical records)
• Fulfils the criteria for the screening log
• Able and willing to provide written informed consent for registry participation
• C. For Randomised Trial Run-in
• Fulfils criteria for the consented registry
• Clinical diagnosis of heart failure for at least 4 weeks

You may not qualify if:

• A, For the Screening Log \& Registry
• \- None
• B. For the Randomised Trial
• eGFR \<30ml/minute/1.73m2 (if clinically appropriate, the dose of other agents such as loop diuretics, ACE inhibitors, angiotensin receptor blockers, beta-blockers and sacubitril-valsartan may be adjusted to allow eGFR to increase)
• Systolic BP \<90mmHg
• Uncorrected valve disease as the main cause of heart failure in the investigators opinion
• Hepatic encephalopathy or known severe liver disease
• Infection currently requiring intravenous antibiotics or temperature \>38°C
• Myocardial ischaemia currently requiring intravenous therapy or coronary intervention in the previous 7 days
• Arrhythmia requiring urgent cardioversion or intravenous therapy
• Severe hyperkalaemia requiring, in the investigator's opinion, intravenous treatment or a potassium-binding agent
• The patient is already receiving a potassium-binding agent (this includes patiromer) or the treating physician has already decided to use one
• Known hypersensitivity to patiromer or any of the excipients
• Known intolerance to both spironolactone and eplerenone (not including hyperkalaemia)
• Known hypersensitivity to the active substance or excipients of spironolactone and eplerenone as per the current Summary of Product Characteristics (Note: actual medicine supplied to participants will vary depending on local arrangements)

Sponsors & Collaborators

• NHS Greater Glasgow and Clyde: lead
• University of Glasgow: collaborator

Study Sites (11)

Glasgow Royal Infirmary

Glasgow, Strathclyde, G4 0SF, United Kingdom

Location

Basildon University Hospital

Basildon, United Kingdom

Location

Blackpool Victoria Hospital

Blackpool, United Kingdom

Location

Princess of Wales Hospital

Bridgend, United Kingdom

Location

Royal Devon and Exeter Hospital

Exeter, United Kingdom

Location

Queen Elizabeth University Hospital

Glasgow, United Kingdom

Location

Castle Hill Hospital

Hull, United Kingdom

Location

Victoria Hospital

Kirkcaldy, United Kingdom

Location

Guy's and St Thomas's Hospital

London, United Kingdom

Location

King's College Hospital

London, United Kingdom

Location

St George's Hospital

London, United Kingdom

Location

MeSH Terms

Conditions

Heart Failure

Interventions

patiromer

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Limitations and Caveats

Early termination of the trial resulted in small numbers of patients recruited and no available analysis

Results Point of Contact

• Title: Prof John Cleland
• Organization: University of Glasgow

john.cleland@glasgow.ac.uk

0141 330 7774

Study Officials

• John Cleland

  University of Glasgow

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2019
• First Posted: October 29, 2019
• Study Start: August 26, 2020
• Primary Completion: December 20, 2022
• Study Completion: December 20, 2022
• Last Updated: March 4, 2025
• Results First Posted: March 4, 2025

Record last verified: 2024-12

Locations

GB (11)