An observational study in Acute Heart Failure, sponsored by Heart Initiative. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-05-19.
Sponsored by Heart Initiative · Observational
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.
The registry has three main aims:
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.
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.
Exclusion Criteria:
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.
Characteristics of patients admitted to hospital for heart failure
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
Time frame: Baseline
Description of the HF meds prescribed at discharge, and 2 weeks, and 1, 3 and 6 months with respect to optimal doses
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
Time frame: Baseline, Week 2, Month 1, Month 3, Month 6
Risk of death through 6 months
Cumulative risk of all-cause death through 6 months post hospital discharge
Time frame: Month 6
Risk of cardiovascular death through 6 months
Cumulative risk of CV death through 6 months post hospital discharge
Time frame: Month 6
Risk of rehospitalization through 6 months
Cumulative risk of re-hospitalization through 6 months post hospital discharge
Time frame: Month 6
Risk of heart failure rehospitalization through 6 months
Cumulative risk of HF re-hospitalization through 6 months post hospital discharge
Time frame: Month 6
Risk of heart failure rehospitalization or cardiovascular death through 6 months
Cumulative risk of first HF re-hospitalization or CV death through 6 months post discharge
Time frame: Month 6
Proportion with follow-up visit within 1 week, 2 weeks, 1 month, 3 months, 6 months post discharge
Proportion of patients with 1 or more follow-up visits within 1 week, 2 weeks, and 1, 3, and 6 months post hospital discharge
Time frame: Week 1, Week 2, Month 1, Month 3, Month 6
Average time from discharge to first visit
Average number of days between discharge from the hospitalization for acute heart failure and the first outpatient visit post hospital discharge within 6 months
Time frame: Month 6
Average number of follow-up visits within 3 and 6 months
Average number of outpatient follow-up visits within 3 and 6 months post discharge
Time frame: Month 3, Month 6
Proportion of post-discharge visits through 6 months where laboratory values measured
Proportion of post-discharge visits through 6 months where laboratory values, including NT-proBNP, measured
Time frame: Month 6
Proportion of post-discharge visits through 6 months where vital signs measured
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 clinical assessment of congestion done
Proportion of post-discharge visits through 6 months clinical assessments of congestion done
Time frame: Month 6
No study locations are listed for this record.
Plan to share: Yes — 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
This study is not yet recruiting, as verified in May 2023. You cannot join it, but the record below documents what was studied.
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Heart Initiative