Facilitated Access to Optimized Treatment and Clinical Follow-Up for Elderly Patients by the Internal Medicine Heart Failure Outpatient Clinic - a Randomized Multicenter Prospective Study

NCT07040995 | Withdrawn DMC

• 1 other identifier: Dnr 2024-04155-01
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

Research problem and specific questions: Due to lack of resources and an increasingly heavy burden placed on the primary care system, most of heart failure (HF) patients don´t receive a swift follow-up according to guideline recommendations. Our study aims to investigate if a structured and swift follow-up at a dedicated internal medicine HF out-patient clinic (IM-HF)) for older adults with HF post hospital discharge, can improve the quality of life and reduce mortality and re-hospitalization compared to current standard with follow-up within the primary care. Data and method: The study will be performed as a prospective, randomized controlled trial (RCT) at two sites. All patients older than 70 years admitted to a ward with new onset or chronic HF will be invited to participate. After discharge, all patients will be invited to a re-visit to the IM-HF within 2 weeks, and will thereafter be randomized to either continued follow-up on-demand at the IM-HF or within the primary care. Outcomes will be self-reported quality of life, number of days alive and out of hospital, time to death or re-hospitalization and adherence to guideline-directed medical therapy. Data collection will be performed by means of nurse-led interviews, blood sampling and review of medical records. By employing a RCT-design with a well-defined population, intervention, control and outcome, this study aims to provide high-quality evidence that could influence clinical practice. Societal relevance and utilization: The study is expected to give valuable insight into the effects of early and structured follow-up for older adults with HF and could improve the standard of care and lead to improved quality of life and reduced risks of re-hospitalization and mortality. Through multidisciplinary teams and cooperation with patients associations the study aspires to be evidence based and patient centered. The start-up and implementation of the study is expected during the following years and may have important implications for the care of older adults with HF. Plan for project realization: The study aims to start at the IM-HF at two sites in 2025 with a research nurse with a 50% position at each site. About 12 patients fulfilling the inclusion criteria are discharged from the hospital wards each week and we expect an inclusion rate of 4 patients/week. The study is expected to go on for 3.5 years.

Conditions

Heart Failure

Keywords

older adults; elderly; heart failure; follow-up; internal medicine

Outcome Measures

Primary Outcomes (2)

• Quality of Life

  Quality of Life assessed by Kansas City Cardiomyopathy questionnaire, KCCQ

  From enrollment and at 1-, 3- and 6-months

• Days Alive and Out-of-hospital

  Percentage of Days Alive and Out-of-hospital (%DAOH)

  From enrollment and 1 year forward

Secondary Outcomes (2)

• 1-year mortality and 30-day re-admission

  From enrollment and 1 year forward for mortality. From enrollment and 30 days forward for re-admission

• Adherence to guidline-directed medical therapy (GDMT)

  From enrollment and at 1-, 3- and 6-months

Other Outcomes (2)

• Time to 30-day re-admission

  30 days

• Time to 1-year mortality

  1 year

Study Arms (2)

Control arm

NO INTERVENTION

Patients in the control arm will receive follow-up post-discharge at the internal medicine heart failure outpatient clinic within 2 weeks. They will thereafter be referred to their primary care physician

Interventional arm

ACTIVE COMPARATOR

Patients in the interventional arm will receive follow-up post-discharge at the internal medicine heart failure outpatient clinic within 2 weeks. They will thereafter receive further follow-up at the internal medicine heart failure outpatient clinic on-demand for the following 6 months

Other: Swift follow-up

Interventions

Swift follow-up OTHER

Swift and structured follow-up on-demand for 6 months at a disease-specific outpatient clinic following hospitalization for heart failure among older adults

Interventional arm

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Written informed consent (paper-based or digital/remote)
• years or older
• Clinical diagnosis of HF
• Follow-up after hospitalization would otherwise be in the primary care setting

You may not qualify if:

• Eligibility to advanced HF treatment such as device therapy or mechanical support
• Intended follow-up at the Department of Cardiology (electrical cardioversion excluded)
• Inability to give informed consent

Sponsors & Collaborators

• Region Skane: lead

Related Publications (14)

• Greene SJ, Butler J, Albert NM, DeVore AD, Sharma PP, Duffy CI, Hill CL, McCague K, Mi X, Patterson JH, Spertus JA, Thomas L, Williams FB, Hernandez AF, Fonarow GC. Medical Therapy for Heart Failure With Reduced Ejection Fraction: The CHAMP-HF Registry. J Am Coll Cardiol. 2018 Jul 24;72(4):351-366. doi: 10.1016/j.jacc.2018.04.070.

  PMID: 30025570 BACKGROUND

• Mebazaa 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.

  PMID: 36356631 BACKGROUND

• Savarese G, Kishi T, Vardeny O, Adamsson Eryd S, Bodegard J, Lund LH, Thuresson M, Bozkurt B. Heart Failure Drug Treatment-Inertia, Titration, and Discontinuation: A Multinational Observational Study (EVOLUTION HF). JACC Heart Fail. 2023 Jan;11(1):1-14. doi: 10.1016/j.jchf.2022.08.009. Epub 2022 Sep 7.

  PMID: 36202739 BACKGROUND

• Van Spall HGC, Rahman T, Mytton O, Ramasundarahettige C, Ibrahim Q, Kabali C, Coppens M, Brian Haynes R, Connolly S. Comparative effectiveness of transitional care services in patients discharged from the hospital with heart failure: a systematic review and network meta-analysis. Eur J Heart Fail. 2017 Nov;19(11):1427-1443. doi: 10.1002/ejhf.765. Epub 2017 Feb 24.

  PMID: 28233442 BACKGROUND

• Phelan D, Smyth L, Ryder M, Murphy N, O'Loughlin C, Conlon C, Ledwidge M, McDonald K. Can we reduce preventable heart failure readmissions in patients enrolled in a Disease Management Programme? Ir J Med Sci. 2009 Jun;178(2):167-71. doi: 10.1007/s11845-009-0332-6. Epub 2009 May 1.

  PMID: 19408042 BACKGROUND

• Hernandez AF, Greiner MA, Fonarow GC, Hammill BG, Heidenreich PA, Yancy CW, Peterson ED, Curtis LH. Relationship between early physician follow-up and 30-day readmission among Medicare beneficiaries hospitalized for heart failure. JAMA. 2010 May 5;303(17):1716-22. doi: 10.1001/jama.2010.533.

  PMID: 20442387 BACKGROUND

• McDonagh TA, Metra M, Adamo M, Gardner RS, Baumbach A, Bohm M, Burri H, Butler J, Celutkiene J, Chioncel O, Cleland JGF, Crespo-Leiro MG, Farmakis D, Gilard M, Heymans S, Hoes AW, Jaarsma T, Jankowska EA, Lainscak M, Lam CSP, Lyon AR, McMurray JJV, Mebazaa A, Mindham R, Muneretto C, Francesco Piepoli M, Price S, Rosano GMC, Ruschitzka F, Skibelund AK; ESC Scientific Document Group. 2023 Focused Update of the 2021 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure. Eur Heart J. 2023 Oct 1;44(37):3627-3639. doi: 10.1093/eurheartj/ehad195. No abstract available.

  PMID: 37622666 BACKGROUND

• Laveau 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.

  PMID: 28017276 BACKGROUND

• Liljeroos M, Stromberg A. Introducing nurse-led heart failure clinics in Swedish primary care settings. Eur J Heart Fail. 2019 Jan;21(1):103-109. doi: 10.1002/ejhf.1329. Epub 2018 Oct 19.

  PMID: 30338881 BACKGROUND

• Dharmarajan K, Hsieh AF, Lin Z, Bueno H, Ross JS, Horwitz LI, Barreto-Filho JA, Kim N, Bernheim SM, Suter LG, Drye EE, Krumholz HM. Diagnoses and timing of 30-day readmissions after hospitalization for heart failure, acute myocardial infarction, or pneumonia. JAMA. 2013 Jan 23;309(4):355-63. doi: 10.1001/jama.2012.216476.

  PMID: 23340637 BACKGROUND

• Bueno H, Ross JS, Wang Y, Chen J, Vidan MT, Normand SL, Curtis JP, Drye EE, Lichtman JH, Keenan PS, Kosiborod M, Krumholz HM. Trends in length of stay and short-term outcomes among Medicare patients hospitalized for heart failure, 1993-2006. JAMA. 2010 Jun 2;303(21):2141-7. doi: 10.1001/jama.2010.748.

  PMID: 20516414 BACKGROUND

• Norton C, Georgiopoulou VV, Kalogeropoulos AP, Butler J. Epidemiology and cost of advanced heart failure. Prog Cardiovasc Dis. 2011 Sep-Oct;54(2):78-85. doi: 10.1016/j.pcad.2011.04.002.

  PMID: 21875507 BACKGROUND

• Stewart S, Jenkins A, Buchan S, McGuire A, Capewell S, McMurray JJ. The current cost of heart failure to the National Health Service in the UK. Eur J Heart Fail. 2002 Jun;4(3):361-71. doi: 10.1016/s1388-9842(01)00198-2.

  PMID: 12034163 BACKGROUND

• Greene SJ, Fonarow GC, Vaduganathan M, Khan SS, Butler J, Gheorghiade M. The vulnerable phase after hospitalization for heart failure. Nat Rev Cardiol. 2015 Apr;12(4):220-9. doi: 10.1038/nrcardio.2015.14. Epub 2015 Feb 10.

  PMID: 25666406 BACKGROUND

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Amra Jujic, PhD

  Institution of Clinical Sciences, Lund University, Malmö

  STUDY DIRECTOR

• Hannes Holm-Isholth, MD, PhD

  Institution of Clinical Sciences, Lund University, Malmö

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2024
• First Posted: June 27, 2025
• Study Start: January 1, 2025
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: June 27, 2025

Record last verified: 2025-06