Early Detection and IntervenTion in Heart Failure
ConditionHeart Failure (HF)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorUniversity Hospital, Basel, Switzerland
About this trial
Heart failure (HF) occurs when the heart is no longer able to pump blood effectively throughout the body. This leads to symptoms that gradually worsen over time and are often mistaken for normal signs of aging. Because of its insidious onset, early detection is challenging. Both patients and healthcare professionals are often insufficiently aware of the early signs and symptoms of HF, resulting in delayed diagnosis. Consequently, timely initiation of treatments that could slow disease progression, improve quality of life, and reduce hospitalizations is often missed. Although a simple blood test measuring NT-proBNP levels can facilitate the early diagnosis of HF, it is not routinely used in clinical practice.
The aim of this study is to evaluate whether a combined strategy for the early diagnosis and treatment of HF can reduce hospitalizations. This strategy includes:
1. increasing awareness of HF among patients and physicians, 2. using NT-proBNP testing for the early detection of HF in high-risk patients, and 3. promptly initiating guideline-directed HF treatment when the diagnosis is confirmed.
The researchers will assess whether this strategy effectively reduces hospitalizations due to acute heart failure over an 18-month follow-up period.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
General consent (GC) has not been rejected.
Age ≥ 65 years.
Elective percutaneous coronary intervention* (PCI), pulmonary vein isolation* (PVI), pacemaker implantation* (PM, no cardiac resynchronisation), transcatheter aortic valve intervention* (TAVI), major non-cardiac surgery* or presenting with tachyarrhythmia to the emergency department (ED) (without a diagnosis of HF within 24h).
Disqualifiers
Systolic blood pressure ≤ 95 mmHg
Estimated glomerular filtration rate (GFR) <30 mL/min/1.73 m2.
Dementia documented in the medical history.
Metastatic cancer in the medical history.
Trial design
Design model
Parallel
Treatments tested in this trial
Intervention bundle comprising increased awareness, early diagnostics, and early treatment to improve HF prognosis.
Other interventionThe study aims to fill critical gaps and evaluate patient-centred outcomes, including hospitalization for acute HF, and health economic implications by using routine clinical data and the standard operating procedures as part of routine clinical practice in the participating sites.
Treatment groups
18,000 Participants
are divided into 2 treatment groupsGroup A: Phase INo intervention 0 interventions
Group B: Phase IIOther 1 intervention
Trial outcomes
Primary outcomes
1
Acute HF event
Time from the index procedure to an acute HF event or follow-up date, together with binary variable indicating the occurrence of an acute Hf event. Acute HF event during index hospitalization is defined as acute HF severe enough to require admission to an intensive/intermediate care unit, non-invasive ventilation, or treatment with at least 40mg furosemide IV.
Time frame
18 months after interventionSecondary outcomes
1
CV death or acute HF event
Time from index hospitalisation to acute HF event, CV death or follow-up date, together with binary variable indicating the occurrence of acute HF event or CV death.
Time frame
18 months2
Hierarchical ordinal composite of CV death, acute HF hospitalization, acute HF during index hospitalization, and no event
Hierarchical ordinal composite of CV death, acute HF hospitalization, acute HF during index hospitalization, and no event (analyzed using the Finkelstein-Schoenfeld win ratio framework. Ties will be resolved according to the predefined event hierarchy. The effect measure will be the win ratio with 95% confidence intervals and two-sided p-values).
Time frame
18 months3
All-cause death
Time from index hospitalisation to hospitalization for acute HF, death, or follow-up date, together with binary variable indicating the occurrence of hospitalization for acute HF or death.
Time frame
18 months4
Cardiovascular death
Time from index hospitalisation to CV death or follow-up date, together with binary variable indicating CV death.
Time frame
18 monthsOther outcomes
1
Outcomes for implementation
Feasibility and Appropriateness of the implementation strategy according to Weiner et. al.
Time frame
18 months2
Prevalence of undetected / untreated / suboptimal treated HF patients overall and in the different medical settings
Continuous variable representing the proportion of patients in the entire study population, this includes patients as well with exclusions criteria.
Time frame
18 months3
Ratio between previously known and undetected HF overall and in the different medical settings, and the corresponding number needed to screen to detect one patient with undetected HF
Continuous variable representing the proportion of newly diagnosed HF patients to previously diagnosed HF cases again assed in the overall population, this includes patients as well with exclusions criteria.
Time frame
18 monthsSponsors and contacts
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Source ClinicalTrials.gov