NCT05865665Not yet recruiting
Registry Of Best Up-titration STrategies in Acute Heart Failure
Registry Of Best Up-titration STrategies in Acute Heart Failure (ROBUST-HF): a Registry of Post-acute Heart Failure Management
Source: ClinicalTrials.gov · Last updated 19 May 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 5000 (estimated)
- First submitted
- 3 Apr 2023
- Start date
- Jun 2023
- Primary completion date
- Dec 2027
- Lead sponsor
- Heart Initiative
- Diseases
- Heart failure
- NCT number
- NCT05865665
What you commit to
- Study type: Observational
- Planned participants: 5000
- From Jun 2023 to the primary completion date, Dec 2027
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Myocardial infarction, unstable angina or cardiac surgery, or percutaneous transluminal coronary intervention (PTCI), within 1 month prior to enrolment.
- Presence at enrolment of any severe valvular stenosis or regurgitation in need of surgical correction.
Other illness
- Currently enrolled in a clinical study that mandates a schedule of follow-up visits for heart failure, or particular assessments or treatment for heart failure.
Lab values
- Last measurement during the hospital admission prior to enrollment of eGFR \< 30 mL/min/1.73m2 or history of dialysis.
Age
- Age \< 18
Who the study is looking for
- Admitted to the hospital for acute heart failure (diagnosed by dyspnea at rest and pulmonary congestion on chest X-ray or lung ultrasound) more than 72 hours prior to enrolment.
- All measures within 24 hours prior to enrolment of systolic blood pressure ≥ 100 mmHg, and of heart rate ≥ 60 bpm.
- The last measurement during the hospital admission prior to enrolment of serum potassium ≤ 5.0 mEq/L (mmol/L).
- The last measuremet during the hospital admission prior to enrolment of NT-proBNP \> 1,500 pg/mL
- At admission and at the time of enrolment being prescribed: (1) none to \< ½ the optimal dose (per the protocol) of renin angiotensin system inhibitor (RASi) - angiotensin converting enzyme inhibitor (ACEi), angiotensin receptor blocker (ARB), or angiotensin receptor-neprilysin inhibitor (ARNI), AND (2) none to \< ½ the optimal dose of beta-blocker (BB), AND (3) none to ≤ ½ the optimal dose of mineralocorticoid receptor antagonist (MRA).
- Written informed consent to participate in the study.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.