Registry Of Best Up-titration STrategies in Acute Heart Failure (ROBUST-HF)

Heart Initiative

Status: Not yet enrolling

Conditions: Acute Heart Failure

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT05865665

CHF202201

Details and patient eligibility

About

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.

Full description

The registry has three main aims:

1. Describe in a multi-national multi-site registry the post-discharge care of patients with AHF, inclusive of number of post-discharge visits and their timing, care providers conducting those visits, medications prescribed to patients, follow-up exams, inclusive of labs and NT-proBNP and finally outcomes during the first 6 months post-discharge.
2. Provide professional education and resources for physicians to accelerate the initiation and up-titration of evidence-based, guideline-directed medical therapies in appropriate patients following AHF hospitalization.
3. Provide hospitals and country leaders information on patterns of care for patients discharged from an admission for acute HF by summarizing and providing benchmark data reports.

This is a prospective, multinational, multicenter, observational registry of patients admitted to hospital more than 72 hours for AHF who were not previously treated with optimal doses of GDMT for HF. Prior to enrollment of patients in the registry, participating investigators will be trained with respect to best practices for management of GDMT. Patients at participating centers who meet all eligibility criteria will be enrolled at least 72 hours following admission to hospital for AHF, and data regarding the patient's characteristics and the initial hospitalization will be collected. Data including examinations, blood test results, and prescribed medications will be collected for each post-discharge outpatient visit through 6 months post-discharge. Detail regarding any death or re-hospitalization through 6 months will be collected. Patients will be contacted by phone at 6 months to assess vital status, the occurrence of any rehospitalizations, and prescribed HF medications. Patients will be enrolled into the registry in each site in at least two blocks. Each block within site will represent a period of 4 months during which at least 15 patients will be enrolled. After the end of the 4-month enrolment period and after the enrolled patients have been followed for 6 months, data from these patients will be summarized and presented to the site. Following discussions with the sites, a second period of 4 months during which an additional at least 15 patients will be enrolled will be undertaken. Once the last patient in this enrolment period has reached 6 months follow up, data will be again summarized and presented to the site for discussion. Professional education regarding effective implementation of most recent guideline-directed medical therapy will be carried out, both before the initiation of a site and during the study, as well as after all patients in the first enrolment period and second enrolment period have reached 6 months follow-up and the data summarized and presented to the site. Efforts would include site-level discussions, country-level meetings/teleconferences and global meetings/teleconferences. Educational efforts will be aimed at providing the most up to date cardiovascular science and guidelines and best practice sharing to facilitate the transfer of knowledge into practice; as well as highlighting performance gaps and providing strategies to improve that performance driving to improving patient outcomes.

Enrollment: 5,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 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.
2. All measures within 24 hours prior to enrolment of systolic blood pressure ≥ 100 mmHg, and of heart rate ≥ 60 bpm.
3. The last measurement during the hospital admission prior to enrolment of serum potassium ≤ 5.0 mEq/L (mmol/L).
4. The last measuremet during the hospital admission prior to enrolment of NT-proBNP > 1,500 pg/mL
5. 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).
6. Written informed consent to participate in the study.

Exclusion criteria

1. Age < 18
2. Myocardial infarction, unstable angina or cardiac surgery, or percutaneous transluminal coronary intervention (PTCI), within 1 month prior to enrolment.
3. Presence at enrolment of any severe valvular stenosis or regurgitation in need of surgical correction.
4. Last measurement during the hospital admission prior to enrollment of eGFR < 30 mL/min/1.73m2 or history of dialysis.
5. 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.

Trial design

5,000 participants in 1 patient group

Patients hospitalized for acute heart failure

Description:

Patients admitted for acute heart failure for at least 72 hours who are not treated with optimal doses of oral medications for HF including renin-angiotensin system inhibitors (RASI), beta-blockers (BB), and mineralocorticoid receptor antagonists (MRA) meeting all eligibility criteria including elevated NT-proBNP.