Registry Of Best Up-titration STrategies in Acute Heart Failure (ROBUST-HF): a Registry of Post-acute Heart Failure Management

NCT05865665 NOT_YET_RECRUITING

STRONG-HF showed that rapid up-titration of renin-angiotensin inhibitor (RASI), beta-blocker, and mineralocorticoid receptor antagonist (MRA) to full optimal doses within 2 weeks post-discharge from a hospital admission for acute heart failure (AHF), using frequent safety assessments, significantly reduced the 180-day risk of HF readmission or death and significantly increased 90-day quality of life regardless of left ventricular ejection fraction (LVEF). Recent evidence also suggests that initiation of angiotensin-receptor neprilysin inhibitor (ARNI) and SGLT-2 inhibitors close to the time of discharge regardless of LVEF, and iron supplementation where indicated, improve patient prognosis. In this prospective registry of patients not treated with optimal doses of oral HF medications being discharged from an admission for AHF, ROBUST-HF, data will be collected describing their post-discharge care including the management of their oral HF medications and frequency and content of post-discharge assessments and clinical outcomes through 6 months post discharge.

Details

Lead sponsor	Heart Initiative
Status	NOT_YET_RECRUITING
Enrolment	5000
Start date	2023-06
Completion	2027-12

Conditions

• Acute Heart Failure

Primary outcomes

• Characteristics of patients admitted to hospital for heart failure — Baseline
  Description of characteristics of patients enrolled including demographics, general and heart failure medical history, pre-admission and discharge HF medications, vital signs and laboratory findings
• Description of the HF meds prescribed at discharge, and 2 weeks, and 1, 3 and 6 months with respect to optimal doses — Baseline, Week 2, Month 1, Month 3, Month 6
  Proportions of patients on any and on \<½, ½-\<full and ≥ full optimal doses of heart failure medication in each class (renin-angiotensin-system inhibitor or angiotensin receptor-neprilysin inhibitor, mineralocorticoid receptor antagonist, beta blocker, sodium-glucose co-transporter 2 inhibitor) at hospital discharge (baseline), and 2 weeks, 1 month, 3 months, and 6 months post hospital discharge
• Risk of death through 6 months — Month 6
  Cumulative risk of all-cause death through 6 months post hospital discharge
• Risk of cardiovascular death through 6 months — Month 6
  Cumulative risk of CV death through 6 months post hospital discharge
• Risk of rehospitalization through 6 months — Month 6
  Cumulative risk of re-hospitalization through 6 months post hospital discharge
• Risk of heart failure rehospitalization through 6 months — Month 6
  Cumulative risk of HF re-hospitalization through 6 months post hospital discharge