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NCT Number: NCT05865665

Registry Of Best Up-titration STrategies in Acute Heart Failure

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.

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Key information

Conditions

Acute Heart Failure

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

The registry has three main aims:

  • 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.
  • 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.
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • Age < 18
  • 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.
  • Last measurement during the hospital admission prior to enrollment of eGFR < 30 mL/min/1.73m2 or history of dialysis.
  • 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.

Treatment and study plan

Primary outcomes

  1. Characteristics of patients admitted to hospital for heart failure

    Time frame: 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

  2. Description of the HF meds prescribed at discharge, and 2 weeks, and 1, 3 and 6 months with respect to optimal doses

    Time frame: 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

  3. Risk of death through 6 months

    Time frame: Month 6

    Cumulative risk of all-cause death through 6 months post hospital discharge

  4. Risk of cardiovascular death through 6 months

    Time frame: Month 6

    Cumulative risk of CV death through 6 months post hospital discharge

  5. Risk of rehospitalization through 6 months

    Time frame: Month 6

    Cumulative risk of re-hospitalization through 6 months post hospital discharge

  6. Risk of heart failure rehospitalization through 6 months

    Time frame: Month 6

    Cumulative risk of HF re-hospitalization through 6 months post hospital discharge

  7. Risk of heart failure rehospitalization or cardiovascular death through 6 months

    Time frame: Month 6

    Cumulative risk of first HF re-hospitalization or CV death through 6 months post discharge

  8. Proportion with follow-up visit within 1 week, 2 weeks, 1 month, 3 months, 6 months post discharge

    Time frame: Week 1, Week 2, Month 1, Month 3, Month 6

    Proportion of patients with 1 or more follow-up visits within 1 week, 2 weeks, and 1, 3, and 6 months post hospital discharge

  9. Average time from discharge to first visit

    Time frame: Month 6

    Average number of days between discharge from the hospitalization for acute heart failure and the first outpatient visit post hospital discharge within 6 months

  10. Average number of follow-up visits within 3 and 6 months

    Time frame: Month 3, Month 6

    Average number of outpatient follow-up visits within 3 and 6 months post discharge

  11. Proportion of post-discharge visits through 6 months where laboratory values measured

    Time frame: Month 6

    Proportion of post-discharge visits through 6 months where laboratory values, including NT-proBNP, measured

  12. Proportion of post-discharge visits through 6 months where vital signs measured

    Time frame: Month 6

    Proportion of post-discharge visits through 6 months where vital signs measured

  13. Proportion of post-discharge visits through 6 months where clinical assessment of congestion done

    Time frame: Month 6

    Proportion of post-discharge visits through 6 months clinical assessments of congestion done

Study contacts

Contact information is provided by the study sponsor or research team.

Maria Novosadova, MD

CONTACT

[email protected]

+7 985 776 73 12

Sponsors and collaborators

Lead sponsor

Heart Initiative

Other

Collaborators

  • Hôpitaux Universitaires Saint-Louis-Lariboisière
  • INSERM UMR-942, Paris, France
  • Momentum Research, Inc.
  • Roche Diagnostics GmbH

Registry information

Official study title

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

Acronym: ROBUST-HF

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
May 19, 2023
Registry last updated
May 19, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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