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

May 9, 2023 updated by: Heart Initiative

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Detailed 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.

Study Type

Observational

Enrollment (Anticipated)

5000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Up to 5000 patients in up to 60 countries in Europe, the United States, Asia, Africa, and Latin America, in up to 300 sites globally. 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) who meet all the inclusion criteria and none of the exclusion criteria will be enrolled.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Patients hospitalized for acute heart failure
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline
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
Baseline, Week 2, Month 1, Month 3, Month 6
Risk of death through 6 months
Time Frame: Month 6
Cumulative risk of all-cause death through 6 months post hospital discharge
Month 6
Risk of cardiovascular death through 6 months
Time Frame: Month 6
Cumulative risk of CV death through 6 months post hospital discharge
Month 6
Risk of rehospitalization through 6 months
Time Frame: Month 6
Cumulative risk of re-hospitalization through 6 months post hospital discharge
Month 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
Month 6
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
Month 6
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
Week 1, Week 2, Month 1, Month 3, Month 6
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
Month 6
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
Month 3, Month 6
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
Month 6
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
Month 6
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
Month 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Heart Initiative

Collaborators

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

Investigators

  • Principal Investigator: Alexandre Mebazaa, MD, Hôpitaux Universitaires Saint-Louis-Lariboisière, University Paris Diderot, Inserm 942

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

June 1, 2023

Primary Completion (Anticipated)

December 1, 2027

Study Completion (Anticipated)

December 1, 2027

Study Registration Dates

First Submitted

April 3, 2023

First Submitted That Met QC Criteria

May 9, 2023

First Posted (Actual)

May 19, 2023

Study Record Updates

Last Update Posted (Actual)

May 19, 2023

Last Update Submitted That Met QC Criteria

May 9, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHF202201

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Individual participant data required to reach aims in an approved proposal, after de-identification, will be made available to investigators whose proposed use of the data has been approved by the study's Executive Committee. Proposals may be submitted up to 36 months after study completion and should be directed to the study's Principal Investigator

IPD Sharing Time Frame

36 months after study completion

IPD Sharing Access Criteria

The proposed use must be approved by the study's Executive Committee.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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