Registry Of Best Up-titration STrategies in Acute Heart Failure

NCT05865665 | Not Yet Recruiting

• 1 other identifier: CHF202201
• Study Type: observational
• Target: 5,000
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Acute Heart Failure

Keywords

Disease management; Medication therapy management; Biomarkers

Outcome Measures

Primary Outcomes (13)

• 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

  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

  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

  Month 6

• Risk of cardiovascular death through 6 months

  Cumulative risk of CV death through 6 months post hospital discharge

  Month 6

• Risk of rehospitalization through 6 months

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

  Month 6

• Risk of heart failure rehospitalization through 6 months

  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

  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

  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

  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

  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

  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

  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

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

  Month 6

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Related Publications (14)

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  PMID: 36519644 BACKGROUND

• Davison BA, Senger S, Sama IE, Koch GG, Mebazaa A, Dickstein K, Samani NJ, Metra M, Anker SD, Cleland JG, Ng LL, Mordi IR, Zannad F, Filippatos GS, Hillege HL, Ponikowski P, van Veldhuisen DJ, Lang CC, van der Meer P, Nunez J, Bayes-Genis A, Edwards C, Voors AA, Cotter G. Is acute heart failure a distinctive disorder? An analysis from BIOSTAT-CHF. Eur J Heart Fail. 2021 Jan;23(1):43-57. doi: 10.1002/ejhf.2077. Epub 2021 Jan 22.

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Study Officials

• Alexandre Mebazaa, MD

  Hôpitaux Universitaires Saint-Louis-Lariboisière, University Paris Diderot, Inserm 942

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maria Novosadova, MD

CONTACT

+7 985 776 73 12; marianovosadova@momentum-research.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2023
• First Posted: May 19, 2023
• Study Start: June 1, 2023
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: May 19, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share
• Time Frame: 36 months after study completion
• Access Criteria: The proposed use must be approved by the study's Executive Committee.