Management of Patients With Heart Failure at Home After Hospital Discharge

Official title

Contemporary Post-Discharge Management in Heart Failure at Home

Overview

This study aims to assess whether patients with acute heart failure (HF) can achieve the same level of HF-therapies by digital follow-up at home as compared to hospital visits according to the STRONG-HF strategy. Patients admitted to hospital with acute HF will be enrolled and randomized to either follow-up at the hospital out-patient clinic or digital follow-up at home.

Detailed description

This study seeks to enhance the management of HF patients by demonstrating that follow-up and medication up-titration can be effectively carried out digitally at home, thereby relieving the burden on healthcare systems and patients. There exists a substantial knowledge gap in the implementation of life-saving HF drugs that have been shown to significantly reduce mortality in HF patients, by as much as 73%. Despite strong evidence from clinical trials and guidelines, the utilization of optimal HF therapy among patients remains low. The successful STRONG-HF trial demonstrated improved outcomes through early and rapid up-titration of HF medications and follow-up at specialized HF clinics after discharge, and this strategy is now strongly recommended in the updated European Society of Cardiology Heart Failure Guidelines from 2023. However, a major challenge was the need for patients to travel to the hospital for weekly visits, which posed significant barriers for many patients, especially in geographically dispersed regions due to travel distance, immobility, and logistical challenges. To address this gap, the STRONG@HOME trial aims to conduct visits and rapid up-titration of medications in the patient's home, a strategy not previously tested in a clinical trial and with direct clinical implications. The success of this approach has the potential to improve HF care globally and advance the field of implementation science in HF and other chronic diseases.

Interventions

• Other Digital follow-up and uptitration of medications at home after hospital discharge for heart failure
  Both arms will treat the patients according to the STRONG-HF intensive care strategy, as recommended by current guidelines. That is up-titration to at least half of maximum tolerated doses of HF medications at discharge, followed by up-titration to maximum tolerated doses after 2 weeks. Safety visits will be performed after 1, 3 and 6 weeks.
• Other Follow-up and uptitration of medications at the hospital outpatient-clinic after hospital discharge for heart failure
  Both arms will treat the patients according to the STRONG-HF intensive care strategy, as recommended by current guidelines. That is up-titration to at least half of maximum tolerated doses of HF medications at discharge, followed by up-titration to maximum tolerated doses after 2 weeks. Safety visits will be performed after 1, 3 and 6 weeks.

Primary outcome measures

• Guideline recommended medical treatment Score (0-9) [Time frame: 90 days]
• Treatment-emergent adverse events [Time frame: 90 days]

Secondary outcome measures (12)

• Achieved dose in each of the components of the primary endpoint (mg) [Time frame: 90 days]
• Proportion of patients with baseline LVEF<40% with ≥50% dose of guideline recommended heart failure medications [Time frame: 90 days]
• Change in quality of life by EQ-5D index [Time frame: 90 days]
• Change in quality of life by EQ-5D VAS [Time frame: 90 days]
• Change in N-terminal pro-B-type natriuretic peptide (ng/L) [Time frame: 90 days]
• Change in echocardiographic measures of left ventricular structure [Time frame: 90 days]
• Change in body weight (kg) [Time frame: 90 days]
• Self-care [Time frame: 90 days]
• Patient satisfaction with digital follow-up [Time frame: 90 days]
• Number of heart failure readmissions [Time frame: 12 months and 24 months]
• Number of total readmissions [Time frame: 12 months and 24 months]
• Time out of hospital [Time frame: 12 months and 24 months]

Eligibility criteria

Inclusion criteria

• Hospital admission within the 72 hours prior to screening for acute HF.
• NT-proBNP ≥ 1,000 pg/mL measured during the hospitalization
• Systolic blood pressure ≥ 100 mmHg and of heart rate ≥ 60 bpm within 24 hours before randomization
• Serum potassium ≤ 5.0 mEq/L (mmol/L).
• ≤ ½ the optimal dose of ACEi/ARB/ARNi or beta-blocker or MRA.
• Written informed consent to participate in the study.

Exclusion criteria

• Age below 18 or above 85 years.
• Clearly documented intolerance to high doses of beta-blockers
• Clearly documented intolerance to high doses of renin-angiotensin system (RAS) blockers (both ACEi and ARB).
• Renal disease or estimated glomerular filtration rate (eGFR) below 30 mL/min/1.73m2 at screening or history of dialysis.
• Prior (defined as less than 30 days from screening) or current enrollment in a HF intervention or participation in an investigational drug or device study within the 30 days prior to screening
• Index event (admission for acute HF) triggered primarily by a completely reversable etiology so that it is unlikely the patient will be classified with chronic HF after discharge, such as Takotsubo syndrome (stress cardiomyopathy). In the setting of acute coronary syndrome or tachycardia, this should be managed before considering the presence of HF. This does not apply to patients with chronic HF prior to the index event.
• Severe non-adherence to medications
• Psychiatric or neurological disorder, cirrhosis, or active malignancy leading to a life expectancy less than 6 months.
• History of heart transplant or on a transplant list, or using or planned to be implanted with a ventricular assist device.
• Uncorrected thyroid disease, active myocarditis, or known amyloid or hypertrophic obstructive cardiomyopathy.
• Inability to comply with all study requirements, due to major co-morbidities, social or financial issues, or a history of noncompliance with medical regimens, that might compromise the patients ability to understand and/or comply with the protocol instructions or follow-up procedures.
• Low digital competency classified as inability to handle a smartphone or tablet.
• Language barriers requiring the need for an external interpreter.
• Pregnant or nursing (lactating) women.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Health services research

Study locations

Norway · 11 centers

• Akershus University Hospital — Lørenskog
• Drammen Hospital, Vestre Viken HF — Drammen
• Sørlandet Sykehus — Arendal
• Ålesund Hospital — Ålesund
• Innlandet sykehus — Hamar
• Levanger Sykehus — Levanger
• Østfold Hospital — Moss
• Oslo University Hospital — Oslo
• … and 3 more centers

Publications

• 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 PMID 36356631

Identifiers

NCT: NCT06576752 · 721190

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗