Management of Patients With Heart Failure at Home After Hospital Discharge

ConditionHeart Failure

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorUniversity Hospital, Akershus

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

Digital follow-up and uptitration of medications at home after hospital discharge for heart failure
Other intervention
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.
Follow-up and uptitration of medications at the hospital outpatient-clinic after hospital discharge for heart failure
Other intervention
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.

Treatment groups

450 Participants

are divided into 2 treatment groups

Group A: Home careExperimental treatment 1 intervention

Group B: Hospital careActive comparator 1 intervention

Trial outcomes

Primary outcomes

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

Time frame

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 \<55 bpm, and serum potassium of \>5.0 mmol/L.

Time frame

90 days

Secondary outcomes

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

Renin-angiotensin-system blockers, mineralocorticoid receptor antagonists and beta blockers, and treatment with sodium-glucose cotransporter-2-inhibitors

Time frame

90 days

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

Proportion of patients with ≥50% dose of renin-angiotensin-system blockers, mineralocorticoidreceptor antagonists and beta blockers, and treatment with sodium-glucose cotransporter-2-inhibitors in the subgroup with baseline left ventricular ejection fraction\<40%

Time frame

90 days

Change in quality of life by EQ-5D index

Measured by EuroQol Group (EQ-5D) index questionnaire (range 11111 to 55555, higher is worse)

Time frame

90 days

Change in quality of life by EQ-5D VAS

Measured by EuroQol Group (EQ-5D) questionnaire (range 0 to 100, lower is worse)

Time frame

90 days

Other outcomes

CardioSignal congestion index

Performance of the CardioSignal congestion index in detecting worsening HF: HF hospitalizations, increasing NT-proBNP and clinical congestion

Time frame

90 days

Sponsors and contacts

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University Hospital, Akershus

Lead sponsor

Oslo University Hospital

Collaborator

Source ClinicalTrials.gov

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