CUSTOM-AF

2020

Individuals with atrial fibrillation are at increased risk of an ischemic stroke. Active detection of atrial fibrillation (AF) and optimal referral and treatment of patients could prevent an estimated 1500 ischemic strokes annually. Effective collaboration between primary and secondary care professionals is essential for achieving this goal of stroke prevention attributed to AF. This is the primary objective of the implementation consortium known as CUSTOM-AF.

The origin

The CUSTOM-AF was founded in June 2020 and restarted in 2022. CUSTOM-AF implementation consortium aims to share successful practice examples with regional networks and develop guidelines for organizing active detection and integrated care within a network. Additionally, consortium partners seek innovative methods for general practitioners to detect and manage AF without necessitating hospital referrals.

With this consortium, the Dutch Heart Foundation, NVVC Connect, Harteraad, and the Dutch CardioVascular Alliance, all work together towards optimal care for patients with AF. The Dutch College of General Practitioners (NHG) serves as a key advisor to the consortium.

Earlier detection and better treatment of atrial fibrillation, the most common cardiac arrhythmia in adults, is an important part of the cardiovascular disease research agenda that the Dutch Heart Foundatoin set in 2014, which funds the CUSTOM-AF consortium.

The Research
The scope of the consortium has been expanded to include two disorders: heart failure and AF. The consortium has undertaken significant initiatives over the past two years (2020-2022) to advance its objectives:

Guideline Development: The consortium developed the "Screening and Treatment Optimization for AF" guideline, designed to facilitate early detection of AF within regional healthcare systems.
Cost-Effectiveness Analysis: A comprehensive analysis conducted to assess various screening scenarios for AF, evaluating the economic feasibility of different approaches.
Thematic Collaboration: In early 2022, a thematic collaboration titled "Juiste Hartzorg op de Juiste Plek" was established in partnership with the Heart Foundation and ZonMw. This collaboration secured funding for 22 regions to support transmural collaboration on AF and HF, with a focus on early detection and treatment optimization.

Moving forward from September 2022, NVVC Connect will intensify support for the regions by emphasizing continuous improvement through the PDCA cycle, facilitating knowledge sharing, and implementing innovative approaches. These efforts are aimed at strengthening collaboration and improving outcomes in AF and HF care across the participating regions.

Collaborators

Contact person:

MSc. A. de Bruin (Anja)

adebruin@nvvc.nl

Principal investigators

Dr. M.E.W. Hemels (Martin)

MHemels@Rijnstate.nl

Dr. R.G. Tieleman (Robert)

r.tieleman@gmail.com

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Digoxin is the oldest, market-authorized drug for heart failure (HF), and very cheap. A large trial with digoxin, the DIG trial, executed in the early nineties revealed a highly significant reduction in HF hospitalizations, but no effect on mortality. A post-hoc analysis of the DIG trial suggests that low serum concentrations of digoxin may not only improve HF hospitalizations but also mortality in chronic HF patients. To validate these findings, a prospective, randomized, placebo-controlled trial is required to redefine the role of digoxin in modern HF treatment.
The Focus
The primary objective of this study is to investigate whether low-level digoxin (targeting serum concentrations of 0.5-0.9 ng/mL), compared to a placebo, reduces (repeated) HF hospitalizations, (repeated) urgent HF hospital visits, and cardiovascular mortality when added to standard guideline-recommended therapies in chronic HF patients with reduced or mid-range ejection fractions (LVEF ≤50%).
The Research
This proposed trial is a national, multicenter, randomized, double-blind, placebo-controlled clinical trial involving 982 chronic HF patients aged ≥18 years, classified as NYHA II to ambulatory IV, LVEF ≤50%, and specific serum NT-proBNP concentrations based on rhythm and recent HF hospitalization status. Patients must also be on guideline-recommended therapies. The study population includes at least one-third with atrial fibrillation (AF) and one-third women to represent the real-life HF population.
Patients were randomized to receive either a low-level digoxin or a placebo in a double-blinded manner. Digoxin Teva will be administered orally, starting at doses of 0.2mg or 0.1mg (based on age, renal function, and concomitant medication). No loading dose is given to the placebo group. After 4 weeks of evaluating medication (digoxin or placebo), concentrations will be measured. Dose adjustments will be made if needed to reach the target serum digoxin concentration range of 0.5-0.9ng/mL.
The outcomes in reducing adverse cardiovascular events in patients with chronic heart failure of low-dose digoxin will be compared to the outcomes of the placebo.
The origin
This study was funded as part of the Dutch Heart Foundation's collaboration with the ZonMw GGG program on Good Use of Medicines (Goed Gebruik Geneesmiddelen) for better treatment of heart failure and atrial fibrillation, which was one of the 5 priority's that the Dutch Heart Foundation set in 2014. The DECISION study involves 38 hospitals and is led by cardiologists from UMC Groningen and the WCN.

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DOUBLE DOSE

2021

Cardiomyopathies, caused by genetic mutations affecting cardiac muscle components, pose significant economic and societal burdens due to their hereditary nature and early onset. Despite known genetic defects, predicting disease progression remains challenging due to extreme clinical variability. Recent research indicates that cardiomyopathy mutations induce metabolic stress, exacerbated by factors like obesity, which can accelerate disease progression. The Double Dose hypothesis suggests that targeting metabolic stress may offer preventive or curative strategies for these conditions.
The Focus
The Double Dose Consortium aims to understand how cardiomyopathy-causing mutations lead to structural changes in cardiomyocytes. This interdisciplinary effort combines experts in preclinical research, clinical genetics, health technology assessment, and clinical care focused on cardiomyopathy in both children and adults.
The Research
The consortium combines experts in preclinical research, clinical genetics, health technology assessment and clinical researchers with a strong clinical focus on cardiomyopathy in children and adults. These experts investigate how obesity and muscle adiposity contribute to vascular and cardiac muscle dysfunction in mutation carriers through the analysis of clinical data, patient samples, and experimental models. They will also study the mechanisms underlying ultrastructural changes in cardiomyocytes caused by these mutations, leading to impaired metabolism, contraction, relaxation defects, and disrupted cellular communication within the heart.
Utilizing extensive patient cohorts and ongoing studies, the consortium aims to optimize care for cardiomyopathy patients by assessing the cost-effectiveness of diagnostics and clinical interventions. They plan to translate findings on metabolic alterations into clinical trials targeting treatments that reduce metabolic stress. The Double Dose program will establish biobanks containing serum, tissue, and induced pluripotent stem cell-derived cardiomyocytes (iPSC-CMs) to provide mechanistic insights into cardiomyopathy pathophysiology and improve diagnosis and care.
Origin
This consortium was funded through the Impulse Grant program by the Dutch Heart Foundation, together with Stichting Hartedroom. The consortium is a continuation of the Dosis consortium, in which the interaction between mutation and external factors was investigated. They found that cardiomyopathy-mutations induce metabolic stress and that secondary metabolic stress, such as obesity accelerates disease progression.
 

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