Management of Patients with Heart Failure At Home After Hospital Discharge

NCT06576752 | Recruiting DMC

• 1 other identifier: 721190
• Study Type: interventional
• Target: 450
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Heart Failure

Keywords

heart failure; digital health; remote monitoring

Outcome Measures

Primary Outcomes (2)

• Guideline recommended medical treatment Score (0-9)

  Patients are assigned a score for each of the four drug classes, and the sum of these is the total score. For beta-blockers and ACEi/ARBs, patients are assigned 0 (no treatment), 1 (\<50% target daily dose), or 2 points (≥50% target daily dose) for each therapy. Any dose of ARNI instead of ACEi/ARB are assigned 3 points. Any dose of MRA and SGLT2i are assigned 2 points. Proportion of patients with ≥50% dose of ACEi/ARB/ARNI, MRA and beta blocker and treatment with SGLT2i

  90 days

• Treatment-emergent adverse events

  Proportion of patients with eGFR of \<30 mL/min/1.73 m2, systolic BP of \<95 mm Hg, heart rate of \<50 bpm, and serum potassium of \>5.5 mmol/L.

  90 days

Secondary Outcomes (17)

• Achieved dose in each of the components of the primary endpoint (mg)

  90 days

• Proportion of patients with baseline LVEF<40% with ≥50% dose of guideline recommended heart failure medications

  90 days

• Change in quality of life by EQ-5D index

  90 days

• Change in quality of life by EQ-5D VAS

  90 days

• Change in N-terminal pro-B-type natriuretic peptide (ng/L)

  90 days

Study Arms (2)

Home care

EXPERIMENTAL

Follow-up and management of HF medications at home visits after 1, 2, 3 and 6 weeks performed by telecommunication led by HF nurses in close communication with physician at the institution. Around week 2 a single visit to the primary care physician's office is required.

Other: Digital follow-up and uptitration of medications at home after hospital discharge for heart failure

Hospital care

ACTIVE COMPARATOR

Follow-up and management of HF medications provided by specialists at the participating institutions' outpatient clinics after 1, 2, 3 and 6 weeks. (Same as the high-intensity arm in STRONG-HF)

Other: Follow-up and uptitration of medications at the hospital outpatient-clinic after hospital discharge for heart failure

Interventions

Digital follow-up and uptitration of medications at home after hospital discharge for heart failure OTHER

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.

Also known as: Dignio (digital healthcare platform), Checkware (digital healthcare platform), Nimble (digital healthcare platform)

Home care

Follow-up and uptitration of medications at the hospital outpatient-clinic after hospital discharge for heart failure OTHER

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.

Hospital care

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Hospital admission within the 72 hours prior to screening for acute HF.
• NT-proBNP \&gt; 1,500 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Akershus: lead
• Drammen sykehus: collaborator
• Oslo University Hospital: collaborator

Study Sites (2)

Akershus University Hospital

Lørenskog, Akershus, 1478, Norway

RECRUITING

Drammen Hospital, Vestre Viken HF

Drammen, Vestre Viken, 1878, Norway

RECRUITING

Related Publications (1)

• 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

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Central Study Contacts

Peder L Myhre, MD, PhD

CONTACT

+47 93025644; p.l.myhre@medisin.uio.no

Henrik Schirmer, MD, PhD

CONTACT

henrik.schirmer@medisin.uio.no

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 13, 2024
• First Posted: August 29, 2024
• Study Start: October 1, 2024
• Primary Completion: April 1, 2026
• Study Completion (Estimated): April 1, 2028
• Last Updated: March 25, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

NO (2)