A Phase IV, Registry-based, Randomised, Controlled, Open-label Trial Investigating the Potential for Patiromer-facilitated Use of Higher Doses of MRAs in Addition to Standard Care to Improve Congestion, Well-being, Morbidity and Mortality
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 19
- 试验地点
- 11
- 主要终点
- "Congestion Index" on Day 60
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
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).
干预措施: Patiromer (Drug)
结局指标
主要结局
"Congestion Index" on Day 60
时间窗: 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
时间窗: 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
时间窗: Periodically up to 10 years
Composite of time to (re-)hospitalisation or death
次要结局
- Dose of MRA(At 6 months and 12 months)
- Congestion Index(Days 7 and 60)
- Reduced All-cause Mortality(Through study completion, up to 5 years)
- 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)
- NYHA Class(At 6 months and 12 months)
- Patient Global Assessment(At 6 months and 12 months)
- Reduced Non-cancer Mortality(Through study completion, up to 5 years)
- Reduced Cardiovascular Mortality(Through study completion, up to 5 years)
- Reduced Mortality/Morbidity - HF/Non-cancer(During first year)
- Reduced Mortality/Morbidity - Any(During first year)
- QALY(Through study completion, up to 5 years)
- Proportion Alive and Well at 12 Months(At 12 months)
- Dose of Oral Diuretics Other Than MRA(At 6 months and 12 months)
- Participant Characteristics and Assessment of Morbidity and Mortality(Periodically up to 10 years)
- Participant Characteristics/Assessment of Morbidity/Mortality(Periodically up to 10 years)
- Characteristics and Assessment of Morbidity/Mortality(Periodically up to 10 years)
- Characteristics/Assessment of Morbidity/Mortality(Periodically up to 10 years)