Drug Database
HF

HFA Modulite techn

✓ Approved

Chiesi Farmaceutici S.p.A. · therapeutic agent

What is HFA Modulite techn?

HFA Modulite techn is a therapeutic agent developed by Chiesi Farmaceutici S.p.A.. It is approved for therapeutic indications via inhaled.

Drug Profile

CompanyChiesi Farmaceutici S.p.A.
RouteInhaled
StatusApproved
Sources: ClinicalTrials.gov, Chiesi Farmaceutici S.p.A.

Therapeutic Indications

HFA Modulite techn is developed for 1 unique indication across 1 therapeutic area.

Therapeutic AreaConditionPhase
Surgical and medical proceduresOral appliance application✓ Approved

Related Research Articles

PubMedEuropean heart journal. Digital health2026-09-18

Automated assessment of echocardiograms to aid diagnosis of heart failure with preserved ejection fraction.

Venema Constantijn Sebastiaan CS, Venner Max M, Achten Anouk A, Ouwerkerk Wouter W et al.

Diagnosis of heart failure with preserved ejection fraction (HFpEF) using the HFA-PEFF and H2FPEF scores remains challenging in clinical practice and relies on echocardiographic assessment. We aimed to determine whether diagnostic scoring based on automated deep learning interpretation of echocardiograms performs similar to manual measurements in diagnosing HFpEF. We analysed echocardiograms using an automated deep learning algorithm and manually in three cohorts: a test cohort (102 HFpEF patients diagnosed by right heart catheterization and echocardiography), an ambulatory validation cohort (129 HFpEF patients), and a diagnostic validation cohort (n = 427, of which 182 HFpEF and 245 non-HFpEF patients). We evaluated correlations between automated and manual HFA-PEFF and H2FPEF scores across cohorts, their correlation with pulmonary capillary wedge pressures (PCWP), and compared diagnostic accuracy using the area under the curve (AUC). Automated and manual measurements showed good agreement across cohorts, with good correlations between HFA-PEFF (0.78-0.86) and H2FPEF (0.96-0.98) scores and similar correlations with PCWP. One in five patients with high-likelihood HFpEF based on manual HFA-PEFF scores was classified as intermediate-likelihood by automated scores due to lower estimated left atrial volumes, without consistent interaction with atrial fibrillation. Areas under the curve for automated HFA-PEFF and H2FPEF scores did not consistently differ from manual scores {0.70 [95% confidence interval (CI): 0.66-0.74] vs. 0.71 [95% CI: 0.66-0.75] and 0.78 [95% CI: 0.73-0.82] vs. 0.75 [95% CI: 0.71-0.80], respectively}. The HFA-PEFF and H2FPEF scores based on automated and manual echocardiographic analysis showed similar diagnostic accuracy, suggesting automated HFpEF diagnosis using deep learning analysis of echocardiograms is feasible.

PMID 42756927
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PubMedJACC. Advances2026-09-18

The LEDA Score: An Integrated Echocardiographic Score for the Diagnosis of HFpEF.

Palka Przemysław P, Hilling-Smith Roland R, Bell Brendan B, Incani Alex A et al.

Diagnosis of heart failure with preserved ejection fraction (HFpEF) remains challenging because clinical findings may not reflect hemodynamic disease expression. The aim of the study was to evaluate the diagnostic performance of LEDA (Left ventricular concentricity, E/e', left ventricle-to-left atrium Diastasis volume ratio, left Atrial reservoir function), an integrated echocardiographic score, for identifying HFpEF and elevated left-sided filling pressure (LSFP). In this prospective single-center study, 171 selected patients with unexplained dyspnea underwent echocardiography and an invasive hemodynamic assessment within 24 hours. HFpEF was defined by symptoms or signs of heart failure with elevated levels of N-terminal pro-B-type natriuretic peptide and/or invasively measured LSFP ≥15 mm Hg. LEDA integrates left ventricular concentricity, E/e', left ventricular-left atrial diastasis coupling, and left atrial reservoir function. Diagnostic performance was compared with H2FPEF (Heavy, Hypertensive, Atrial fibrillation, Pulmonary hypertension, Elder, Filling pressure score) and HFA-PEFF (Heart Failure Association Pre-test assessment, Echocardiography & natriuretic peptide, Functional testing, Final etiology diagnostic algorithm); 2025 American Society of Echocardiography diastolic criteria were analyzed as an echocardiographic filling-pressure framework rather than as a standalone HFpEF diagnostic score. HFpEF was present in 42% of patients. LEDA showed higher discrimination for HFpEF than for H2FPEF, HFA-PEFF, and American Society of Echocardiography criteria, with area under the curve of 0.85, 0.74, 0.74, and 0.61, respectively (P ≤ 0.010). At LEDA ≥3, the positive likelihood ratio was 7.4, compared with 3.0, 1.8, and 1.6, respectively. For invasive LSFP endpoints, LEDA achieved area under the curve up to 0.90, specificity up to 95.5%, and positive likelihood ratio up to 16.3. In this selected cohort undergoing an invasive hemodynamic assessment for diagnostic uncertainty, LEDA showed stronger diagnostic performance than contemporary HFpEF diagnostic algorithms and an echocardiographic filling-pressure framework. External validation is required before application to broader outpatient populations.

PMID 42759312
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PubMedPacing and clinical electrophysiology : PACE2026-09-18

Characteristics of Low-Voltage Zones in Patients With Heart Failure With Preserved Ejection Fraction.

Tamura Shuntaro S, Nakatani Yosuke Y, Soga Jin J, Iwai Ryutaro R et al.

Atrial fibrillation (AF) frequently coexists with heart failure with preserved ejection fraction (HFpEF), and low-voltage zones (LVZs) in the atria represent atrial remodeling. However, the impact of HFpEF on the extent and distribution of LVZs and ablation outcomes remains unknown. To characterize LVZs in patients with HFpEF undergoing AF ablation and evaluate their association with arrhythmia recurrence. A total of 128 consecutive patients (66±12 years) who underwent AF ablation for the first time were retrospectively analyzed. HFpEF was defined as a left ventricular ejection fraction >50% with a history of heart failure treatment or an HFA-PEFF score ≥5. Meanwhile, LVZs were defined as bipolar voltage <0.5 mV and quantified across five left atrial regions. Forty-seven patients (36.7%) were diagnosed with HFpEF. LVZs were significantly more extensive in the overall left atrium in the HFpEF group (16.3±13.5 vs. 8.2±7.6 cm2, p < 0.001), with the greatest difference being observed in the anterior wall (5.6±5.4 vs. 2.3±2.8 cm2, p < 0.001). During 9±4 months, arrhythmia recurrence rates did not differ significantly between HFpEF and non-HFpEF groups (12.8% vs. 13.6%, p = 0.310). Posterior wall isolation was more frequently performed in the HFpEF group (27.6% vs. 4.9%, p < 0.001). In multivariable analysis, HFpEF, age, and persistent AF were independent determinants of LVZ extent. AF patients with HFpEF exhibit more extensive LVZs, indicating advanced atrial remodeling. Despite differences in atrial substrate and ablation strategy, arrhythmia recurrence rates were comparable between patients with and without HFpEF.

PMID 42754969
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PubMedPlants (Basel, Switzerland)2026-09-15

Biogeographical Differentiation and Key Drivers of the Home-Field Advantage in Cross-Habitat Litter Decomposition: A Global Meta-Analysis.

Mei Tianjiao T, He Xingbing X, Lin Yonghui Y, He Zaihua Z et al.

Global climate change and human activities have jointly exacerbated habitat fragmentation and expanded ecotones, significantly increasing the frequency and intensity of cross-habitat litter decomposition. The phenomenon whereby litter decomposes faster in its habitat of origin ("home") than in other habitats ("away") is known as the home-field advantage (HFA) effect. In-depth exploration of its core mechanisms and key drivers is crucial for revealing the spatial heterogeneity of global carbon and nitrogen cycles and for refining the theory of substance cycling in forest ecosystems. This study integrated 1410 observations from 102 published studies and used meta-analysis to systematically evaluate global patterns, biogeographical differentiation, and key drivers of the HFA effect. The results show that the HFA exhibits significant biogeographical differentiation and is driven by multiple factors. Globally, we found a significant positive HFA (LnRR = 0.0576, p < 0.05), with decomposition-related metrics (e.g., mass loss, decomposition rate) being 5.9% higher at home than away. The strength of the HFA effect shows significant dependence on climate and vegetation types. Regarding vegetation type, significant home-field advantages were observed for coniferous forests (10.15%), deciduous broadleaved forests (8.31%), and evergreen broadleaved forests (6.57%), while no significant differences were detected for shrublands or grasslands. Regarding climate type, subtropical (6.46%), temperate (9.20%), and cold/highland climates (9.53%) exhibited significantly higher home-site effects, whereas tropical and arid/semi-arid climates showed no significant differences. All analyses demonstrated substantial heterogeneity (I2 = 65.5-98.3%). This study also systematically analyzed the associations of three core factor categories (environmental factors such as elevation and precipitation, litter chemical composition, and soil chemical properties) with HFA effect. Among these factors, Litter C/P and Litter N/P were verified as significant positive regulatory factors governing the HFA effect. In conclusion, the driving mechanism of the HFA exhibits systemic characteristics that manifest as the interactive and synergistic effects of multiple factors rather than the independent control of a single factor. Specifically, climate and vegetation types jointly dominate the formation of its macro-geographical patterns, while local abiotic factors (e.g., altitude, precipitation) and litter properties (e.g., chemical composition) further and precisely regulate the strength of the HFA effect through complex interactions. Based on a systematic evaluation using meta-analysis, this study provides an important theoretical basis and data support for understanding the driving mechanisms of the HFA effect in cross-habitat litter decomposition across different ecosystems.

PMID 42739483
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PubMedESC heart failure2026-09-15

The Second Universal Definition of Heart Failure (2026). What's new?

Biegus Jan J, Ponikowski Piotr P

The first Universal Definition and Classification of Heart Failure, published in 2021, standardized the conceptual framework and terminology of heart failure (HF), including pre-HF, HFmrEF, and HFimpEF. The Second Universal Definition (2026), developed by a joint AHA/ACC/ESC/WHF Task Force in collaboration with the HFSA, HFA, and JHFS, builds on this foundation by refining the diagnostic framework and classification of HF. It moves away from rigid left ventricular ejection fraction (LVEF) thresholds for distinguishing HFrEF from HFpEF and proposes three broad LVEF-based categories-HFrEF, HFpEF, and HFimpEF-without retaining HFmrEF as a separate category in the proposed framework. It also proposes a universal classification of HF causes independent of LVEF and clarifies the distinction between worsening and decompensated HF. A broader global perspective incorporates geographic variation in etiology and the influence of social determinants on HF risk and outcomes. This article summarizes the key updates introduced in the 2026 Universal Definition of Heart Failure.

PMID 42744306
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PubMedThe Egyptian heart journal : (EHJ) : official bulletin of the Egyptian Society of Cardiology2026-09-15

Identification and reporting of heart failure with preserved ejection fraction in Sub-Saharan Africa: a scoping review of diagnostic approaches, echocardiographic assessment, and evidence gaps.

Adejumo Faith Adedayo FA, Olaniyan Samuel Gbolagunte SG, Adejumo Temilade Patience TP, Odunaro Sandra Kikelomo SK et al.

Heart failure with preserved ejection fraction (HFpEF) is increasingly recognized as a major heart failure phenotype globally; however, its diagnosis is complex and is recommended to require integrated assessment of clinical features, echocardiographic abnormalities, and biomarkers. In Sub-Saharan Africa (SSA), where diagnostic resources are limited, HFpEF identification may rely on simplified approaches, potentially leading to under-recognition and heterogeneity in reporting. This review evaluates how HFpEF is identified and reported in SSA, with emphasis on diagnostic approaches, echocardiographic characterization, and biomarker use. A scoping review of observational studies reporting heart failure with left ventricular ejection fraction (LVEF) data in Sub-Saharan Africa (SSA) was conducted using predefined eligibility criteria and reported in accordance with PRISMA-ScR. PubMed, Google Scholar, Web of Science, and African Journals Online (AJOL) were searched for relevant studies published in English from database inception to May 2026. Data were extracted on HFpEF definitions, echocardiographic parameters, biomarker use, and diagnostic approaches and frameworks used during the respective study periods. Contemporary HFpEF diagnostic frameworks, including HFA-PEFF and H₂FPEF, were considered separately when interpreting the compatibility of reported phenotyping approaches with current diagnostic concepts. 10 observational studies involving 3,821 patients with heart failure, published between 2009 and 2024, were included. Studies were conducted in South Africa, Nigeria, Senegal, Côte d'Ivoire, Cameroon, and Tanzania, with two multicountry Sub-Saharan African registries also represented. HFpEF definitions were inconsistent, with most studies relying primarily on LVEF ≥ 50% without application of structured diagnostic algorithms. Only two studies reported dedicated HFpEF cohorts, while the remainder identified HFpEF as a subgroup within broader heart failure populations. Echocardiographic reporting was highly variable; left ventricular hypertrophy and left atrial enlargement were the most frequently reported structural abnormalities, but diastolic function parameters were inconsistently assessed, and formal grading was rare. Natriuretic peptides were infrequently measured and seldom integrated into diagnostic classification. No study applied contemporary multiparametric diagnostic frameworks such as HFA-PEFF or H₂FPEF scoring systems. HFpEF in SSA is predominantly identified using simplified ejection fraction-based criteria, with limited integration of echocardiographic diastolic assessment and biomarker data. This results in heterogeneous and potentially non-standardized phenotyping across studies, limiting comparability and accurate disease estimation. Strengthening diagnostic standardization through structured echocardiographic reporting, improved access to natriuretic peptide testing, and consideration of adapted multiparametric HFpEF algorithms may help improve diagnostic consistency and research quality in the region. These findings should be interpreted in the context of the heterogeneous and predominantly hospital-based evidence currently available from SSA.

PMID 42736493
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