Acute Heart FailureROBUST-HFNCT05865665
Registry Of Best Up-titration STrategies in Acute Heart Failure
An observational study of Acute Heart Failure, run by Heart Initiative.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Heart Failure
- Type of treatment
- Pill or oral medicine
- How many people
- 5,000 participants
- Where
- No sites listed yet
- Study dates
- Jun 2023to Dec 2027
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Acute Heart Failure
- Keywords
- Disease management, Medication therapy management, Biomarkers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: Month 6
Risk of cardiovascular death through 6 months
Cumulative risk of CV death through 6 months post hospital discharge
Measured: Month 6
Risk of rehospitalization through 6 months
Cumulative risk of re-hospitalization through 6 months post hospital discharge
Measured: Month 6
Risk of heart failure rehospitalization through 6 months
Cumulative risk of HF re-hospitalization through 6 months post hospital discharge
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
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
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
Measured: Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2023
- Study startJun 2023 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Acute Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5,000 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Heart Initiative
- Sponsor type
- University, hospital or other
- Collaborators
- INSERM UMR-942, Paris, France, Hôpitaux Universitaires Saint-Louis-Lariboisière, Momentum Research, Inc., Roche Diagnostics GmbH
- Responsible party
- Sponsor
- Investigators
- Alexandre Mebazaa, MD, Principal investigator, Hôpitaux Universitaires Saint-Louis-Lariboisière, University Paris Diderot, Inserm 942
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05865665
- Sponsor's protocol ID
- CHF202201
- Acronym
- ROBUST-HF
- Status last verified
- May 2023
- First submitted
- 3 Apr 2023
- Last updated
- 19 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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
Publications
Bhatt DL, Szarek M, Steg PG, Cannon CP, Leiter LA, McGuire DK, Lewis JB, Riddle MC, Voors AA, Metra M, Lund LH, Komajda M, Testani JM, Wilcox CS, Ponikowski P, Lopes RD, Verma S, Lapuerta P, Pitt B; SOLOIST-WHF Trial Investigators. Sotagliflozin in Patients with Diabetes and Recent Worsening Heart Failure. N Engl J Med. 2021 Jan 14;384(2):117-128. doi: 10.1056/NEJMoa2030183. Epub 2020 Nov 16.
PubMed 33200892Cotter G, Davison B, Cohen-Solal A, Freund Y, Mebazaa A. Targeting the 'vulnerable' period - first 3-6 months after an acute heart failure admission - the light gets brighter. Eur J Heart Fail. 2023 Jan;25(1):30-34. doi: 10.1002/ejhf.2754. Epub 2022 Dec 21. No abstract available.
PubMed 36519644Davison 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.
PubMed 33340221Hicks KA, Tcheng JE, Bozkurt B, Chaitman BR, Cutlip DE, Farb A, Fonarow GC, Jacobs JP, Jaff MR, Lichtman JH, Limacher MC, Mahaffey KW, Mehran R, Nissen SE, Smith EE, Targum SL. 2014 ACC/AHA Key Data Elements and Definitions for Cardiovascular Endpoint Events in Clinical Trials: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Data Standards (Writing Committee to Develop Cardiovascular Endpoints Data Standards). J Am Coll Cardiol. 2015 Jul 28;66(4):403-69. doi: 10.1016/j.jacc.2014.12.018. Epub 2014 Dec 29. No abstract available.
PubMed 25553722Jaarsma T, van der Wal MH, Lesman-Leegte I, Luttik ML, Hogenhuis J, Veeger NJ, Sanderman R, Hoes AW, van Gilst WH, Lok DJ, Dunselman PH, Tijssen JG, Hillege HL, van Veldhuisen DJ; Coordinating Study Evaluating Outcomes of Advising and Counseling in Heart Failure (COACH) Investigators. Effect of moderate or intensive disease management program on outcome in patients with heart failure: Coordinating Study Evaluating Outcomes of Advising and Counseling in Heart Failure (COACH). Arch Intern Med. 2008 Feb 11;168(3):316-24. doi: 10.1001/archinternmed.2007.83.
PubMed 18268174Laveau F, Hammoudi N, Berthelot E, Belmin J, Assayag P, Cohen A, Damy T, Duboc D, Dubourg O, Hagege A, Hanon O, Isnard R, Jondeau G, Labouree F, Logeart D, Mansencal N, Meune C, Pautas E, Wolmark Y, Komajda M. Patient journey in decompensated heart failure: An analysis in departments of cardiology and geriatrics in the Greater Paris University Hospitals. Arch Cardiovasc Dis. 2017 Jan;110(1):42-50. doi: 10.1016/j.acvd.2016.05.009. Epub 2016 Dec 21.
PubMed 28017276Logeart D, Berthelot E, Bihry N, Eschalier R, Salvat M, Garcon P, Eicher JC, Cohen A, Tartiere JM, Samadi A, Donal E, deGroote P, Mewton N, Mansencal N, Raphael P, Ghanem N, Seronde MF, Chavelas C, Rosamel Y, Beauvais F, Kevorkian JP, Diallo A, Vicaut E, Isnard R. Early and short-term intensive management after discharge for patients hospitalized with acute heart failure: a randomized study (ECAD-HF). Eur J Heart Fail. 2022 Jan;24(1):219-226. doi: 10.1002/ejhf.2357. Epub 2021 Oct 21.
PubMed 34628697Mamas MA, Sperrin M, Watson MC, Coutts A, Wilde K, Burton C, Kadam UT, Kwok CS, Clark AB, Murchie P, Buchan I, Hannaford PC, Myint PK. Do patients have worse outcomes in heart failure than in cancer? A primary care-based cohort study with 10-year follow-up in Scotland. Eur J Heart Fail. 2017 Sep;19(9):1095-1104. doi: 10.1002/ejhf.822. Epub 2017 May 3.
PubMed 28470962Mebazaa A, Davison B, Chioncel O, Cohen-Solal A, Diaz R, Filippatos G, Metra M, Ponikowski P, Sliwa K, Voors AA, Edwards C, Novosadova M, Takagi K, Damasceno A, Saidu H, Gayat E, Pang PS, Celutkiene J, Cotter G. Safety, tolerability and efficacy of up-titration of guideline-directed medical therapies for acute heart failure (STRONG-HF): a multinational, open-label, randomised, trial. Lancet. 2022 Dec 3;400(10367):1938-1952. doi: 10.1016/S0140-6736(22)02076-1. Epub 2022 Nov 7.
PubMed 36356631Morrow DA, Velazquez EJ, DeVore AD, Desai AS, Duffy CI, Ambrosy AP, Gurmu Y, McCague K, Rocha R, Braunwald E. Clinical Outcomes in Patients With Acute Decompensated Heart Failure Randomly Assigned to Sacubitril/Valsartan or Enalapril in the PIONEER-HF Trial. Circulation. 2019 May 7;139(19):2285-2288. doi: 10.1161/CIRCULATIONAHA.118.039331. No abstract available.
PubMed 30955360Ponikowski P, Kirwan BA, Anker SD, McDonagh T, Dorobantu M, Drozdz J, Fabien V, Filippatos G, Gohring UM, Keren A, Khintibidze I, Kragten H, Martinez FA, Metra M, Milicic D, Nicolau JC, Ohlsson M, Parkhomenko A, Pascual-Figal DA, Ruschitzka F, Sim D, Skouri H, van der Meer P, Lewis BS, Comin-Colet J, von Haehling S, Cohen-Solal A, Danchin N, Doehner W, Dargie HJ, Motro M, Butler J, Friede T, Jensen KH, Pocock S, Jankowska EA; AFFIRM-AHF investigators. Ferric carboxymaltose for iron deficiency at discharge after acute heart failure: a multicentre, double-blind, randomised, controlled trial. Lancet. 2020 Dec 12;396(10266):1895-1904. doi: 10.1016/S0140-6736(20)32339-4. Epub 2020 Nov 13.
PubMed 33197395Public Policy Committee, International Society of Pharmacoepidemiology. Guidelines for good pharmacoepidemiology practice (GPP). Pharmacoepidemiol Drug Saf. 2016 Jan;25(1):2-10. doi: 10.1002/pds.3891. Epub 2015 Nov 5. No abstract available.
PubMed 26537534Van Spall HGC, Lee SF, Xie F, Oz UE, Perez R, Mitoff PR, Maingi M, Tjandrawidjaja MC, Heffernan M, Zia MI, Porepa L, Panju M, Thabane L, Graham ID, Haynes RB, Haughton D, Simek KD, Ko DT, Connolly SJ. Effect of Patient-Centered Transitional Care Services on Clinical Outcomes in Patients Hospitalized for Heart Failure: The PACT-HF Randomized Clinical Trial. JAMA. 2019 Feb 26;321(8):753-761. doi: 10.1001/jama.2019.0710.
PubMed 30806695Voors AA, Angermann CE, Teerlink JR, Collins SP, Kosiborod M, Biegus J, Ferreira JP, Nassif ME, Psotka MA, Tromp J, Borleffs CJW, Ma C, Comin-Colet J, Fu M, Janssens SP, Kiss RG, Mentz RJ, Sakata Y, Schirmer H, Schou M, Schulze PC, Spinarova L, Volterrani M, Wranicz JK, Zeymer U, Zieroth S, Brueckmann M, Blatchford JP, Salsali A, Ponikowski P. The SGLT2 inhibitor empagliflozin in patients hospitalized for acute heart failure: a multinational randomized trial. Nat Med. 2022 Mar;28(3):568-574. doi: 10.1038/s41591-021-01659-1. Epub 2022 Feb 28.
PubMed 35228754
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Registry Of Best Up-titration STrategies in Acute Heart Failure (ROBUST-HF): a Registry of Post-acute Heart Failure Management
- ClinicalTrials.gov ID
- NCT05865665
- Acronym / sponsor ID
- ROBUST-HF / CHF202201
- Conditions
- Acute Heart Failure
- Keywords
- Disease management, Medication therapy management, Biomarkers
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Heart InitiativeUniversity, hospital or other
- Collaborators
- INSERM UMR-942, Paris, France, Hôpitaux Universitaires Saint-Louis-Lariboisière, Momentum Research, Inc., Roche Diagnostics GmbH
- Study start
- Jun 2023 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 19 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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).
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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
Risk of death through 6 months
Time frame: Month 6
Cumulative risk of all-cause death through 6 months post hospital discharge
Risk of cardiovascular death through 6 months
Time frame: Month 6
Cumulative risk of CV death through 6 months post hospital discharge
Risk of rehospitalization through 6 months
Time frame: Month 6
Cumulative risk of re-hospitalization through 6 months post hospital discharge
Risk of heart failure rehospitalization through 6 months
Time frame: Month 6
Cumulative risk of HF re-hospitalization through 6 months post hospital discharge
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
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
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
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
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
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2023.
- Background: PubMed 33200892Bhatt DL, Szarek M, Steg PG, Cannon CP, Leiter LA, McGuire DK, Lewis JB, Riddle MC, Voors AA, Metra M, Lund LH, Komajda M, Testani JM, Wilcox CS, Ponikowski P, Lopes RD, Verma S, Lapuerta P, Pitt B; SOLOIST-WHF Trial Investigators. Sotagliflozin in Patients with Diabetes and Recent Worsening Heart Failure. N Engl J Med. 2021 Jan 14;384(2):117-128. doi: 10.1056/NEJMoa2030183. Epub 2020 Nov 16.
- Background: PubMed 36519644Cotter G, Davison B, Cohen-Solal A, Freund Y, Mebazaa A. Targeting the 'vulnerable' period - first 3-6 months after an acute heart failure admission - the light gets brighter. Eur J Heart Fail. 2023 Jan;25(1):30-34. doi: 10.1002/ejhf.2754. Epub 2022 Dec 21. No abstract available.
- Background: PubMed 33340221Davison 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.
- Background: PubMed 25553722Hicks KA, Tcheng JE, Bozkurt B, Chaitman BR, Cutlip DE, Farb A, Fonarow GC, Jacobs JP, Jaff MR, Lichtman JH, Limacher MC, Mahaffey KW, Mehran R, Nissen SE, Smith EE, Targum SL. 2014 ACC/AHA Key Data Elements and Definitions for Cardiovascular Endpoint Events in Clinical Trials: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Data Standards (Writing Committee to Develop Cardiovascular Endpoints Data Standards). J Am Coll Cardiol. 2015 Jul 28;66(4):403-69. doi: 10.1016/j.jacc.2014.12.018. Epub 2014 Dec 29. No abstract available.
- Background: PubMed 18268174Jaarsma T, van der Wal MH, Lesman-Leegte I, Luttik ML, Hogenhuis J, Veeger NJ, Sanderman R, Hoes AW, van Gilst WH, Lok DJ, Dunselman PH, Tijssen JG, Hillege HL, van Veldhuisen DJ; Coordinating Study Evaluating Outcomes of Advising and Counseling in Heart Failure (COACH) Investigators. Effect of moderate or intensive disease management program on outcome in patients with heart failure: Coordinating Study Evaluating Outcomes of Advising and Counseling in Heart Failure (COACH). Arch Intern Med. 2008 Feb 11;168(3):316-24. doi: 10.1001/archinternmed.2007.83.
- Background: PubMed 28017276Laveau F, Hammoudi N, Berthelot E, Belmin J, Assayag P, Cohen A, Damy T, Duboc D, Dubourg O, Hagege A, Hanon O, Isnard R, Jondeau G, Labouree F, Logeart D, Mansencal N, Meune C, Pautas E, Wolmark Y, Komajda M. Patient journey in decompensated heart failure: An analysis in departments of cardiology and geriatrics in the Greater Paris University Hospitals. Arch Cardiovasc Dis. 2017 Jan;110(1):42-50. doi: 10.1016/j.acvd.2016.05.009. Epub 2016 Dec 21.
- Background: PubMed 34628697Logeart D, Berthelot E, Bihry N, Eschalier R, Salvat M, Garcon P, Eicher JC, Cohen A, Tartiere JM, Samadi A, Donal E, deGroote P, Mewton N, Mansencal N, Raphael P, Ghanem N, Seronde MF, Chavelas C, Rosamel Y, Beauvais F, Kevorkian JP, Diallo A, Vicaut E, Isnard R. Early and short-term intensive management after discharge for patients hospitalized with acute heart failure: a randomized study (ECAD-HF). Eur J Heart Fail. 2022 Jan;24(1):219-226. doi: 10.1002/ejhf.2357. Epub 2021 Oct 21.
- Background: PubMed 28470962Mamas MA, Sperrin M, Watson MC, Coutts A, Wilde K, Burton C, Kadam UT, Kwok CS, Clark AB, Murchie P, Buchan I, Hannaford PC, Myint PK. Do patients have worse outcomes in heart failure than in cancer? A primary care-based cohort study with 10-year follow-up in Scotland. Eur J Heart Fail. 2017 Sep;19(9):1095-1104. doi: 10.1002/ejhf.822. Epub 2017 May 3.
- Background: PubMed 36356631Mebazaa A, Davison B, Chioncel O, Cohen-Solal A, Diaz R, Filippatos G, Metra M, Ponikowski P, Sliwa K, Voors AA, Edwards C, Novosadova M, Takagi K, Damasceno A, Saidu H, Gayat E, Pang PS, Celutkiene J, Cotter G. Safety, tolerability and efficacy of up-titration of guideline-directed medical therapies for acute heart failure (STRONG-HF): a multinational, open-label, randomised, trial. Lancet. 2022 Dec 3;400(10367):1938-1952. doi: 10.1016/S0140-6736(22)02076-1. Epub 2022 Nov 7.
- Background: PubMed 30955360Morrow DA, Velazquez EJ, DeVore AD, Desai AS, Duffy CI, Ambrosy AP, Gurmu Y, McCague K, Rocha R, Braunwald E. Clinical Outcomes in Patients With Acute Decompensated Heart Failure Randomly Assigned to Sacubitril/Valsartan or Enalapril in the PIONEER-HF Trial. Circulation. 2019 May 7;139(19):2285-2288. doi: 10.1161/CIRCULATIONAHA.118.039331. No abstract available.
- Background: PubMed 33197395Ponikowski P, Kirwan BA, Anker SD, McDonagh T, Dorobantu M, Drozdz J, Fabien V, Filippatos G, Gohring UM, Keren A, Khintibidze I, Kragten H, Martinez FA, Metra M, Milicic D, Nicolau JC, Ohlsson M, Parkhomenko A, Pascual-Figal DA, Ruschitzka F, Sim D, Skouri H, van der Meer P, Lewis BS, Comin-Colet J, von Haehling S, Cohen-Solal A, Danchin N, Doehner W, Dargie HJ, Motro M, Butler J, Friede T, Jensen KH, Pocock S, Jankowska EA; AFFIRM-AHF investigators. Ferric carboxymaltose for iron deficiency at discharge after acute heart failure: a multicentre, double-blind, randomised, controlled trial. Lancet. 2020 Dec 12;396(10266):1895-1904. doi: 10.1016/S0140-6736(20)32339-4. Epub 2020 Nov 13.
- Background: PubMed 26537534Public Policy Committee, International Society of Pharmacoepidemiology. Guidelines for good pharmacoepidemiology practice (GPP). Pharmacoepidemiol Drug Saf. 2016 Jan;25(1):2-10. doi: 10.1002/pds.3891. Epub 2015 Nov 5. No abstract available.
- Individual participant dataSharing planned: 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alexandre Mebazaa, MD principal investigator
Hôpitaux Universitaires Saint-Louis-Lariboisière, University Paris Diderot, Inserm 942
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Heart Failure, run by Heart Initiative.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 May 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maria Novosadova, MD (+7 985 776 73 12, marianovosadova@momentum-research.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Characteristics of patients admitted to hospital for heart failure (time frame: Baseline). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05865665, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2023; AzTrials last refreshed its copy on 8 Nov 2026.