Heart failure (HF) is a heterogeneous syndrome affecting over 64 million people around the world that involves a decline in functional capacity and quality of life and is associated with significant morbidity and mortality and elevated resource use and health costs. Heart failure is the main cause of hospitalisation in patients over the age of 65 and represents between 1% and 2% of all hospitalisations in the western world. For that reason, HF has become a significant global public health priority.1 In recent decades, HF prognoses, particularly with reduced left ventricular ejection fraction (LVEF), have improved greatly thanks to the appearance of new treatments tested in large and robust clinical trials.2 These clinical trials are excellent tools for comparing the efficacy and safety of various interventions, but their strict inclusion and exclusion criteria mean that some patient subgroups are not represented, preventing results from being generalised to the entire patient population.3 Therefore, faced with a need to discover what is happening in clinical practice or in “real life”, patient registries emerged, which provide information to supplement clinical trials.3,4

In 2008, the Heart Failure and Atrial Fibrillation Workgroup from the Spanish Society for Internal Medicine (SEMI) launched the RICA registry with the aim of determining the clinical and prognostic characteristics of HF patients treated in Internal Medicine (IM) departments.5,6 After 13 years of recruitment, the RICA registry included over 7,000 patients, and the data was used to publish over 50 journal articles in national and international indexed scientific journals, addressing multiple clinical, epidemiological, therapeutic, and prognostic, as well as social and organisational, aspects that affect this syndrome.7–22

The notable changes HF has undergone over the past decade in terms of both clinical and epidemiological aspects, as well as diagnostic criteria and therapeutic targets, has given rise to the need to update the initial research questions and modify the variables needed to answer them. For those reasons, the RICA registry Research Committee decided to update the registry by creating a new registry called RICA-223 (Fig. 1).

Figure 1.

RICA-2 registry.

(0.32MB).

The aim of this paper is to present the design of the new RICA-2 registry as well as the baseline characteristics of the first 1000 patients included in the registry and to compare them with those of the historic cohort from the original RICA registry.

Recruitment for the RICA-2 registry started on 1 December 2022 and by February 2024 had reached enrolment of the first 1000 patients, 47% via external consultation (during the stable phase) and 53% during the decompensation phase. The baseline characteristics of the patients in the RICA-2 registry and from the RICA historic cohort are presented in greater detail in Table 3. The patients included in both registries are older patients (median 81-83 years) and 51-53% are female. Patients from both registries have a higher comorbidity burden, with an increase in the median Charlson Index score from 3 to 5 points between RICA and RICA-2, impacting an increase in the cardiovascular risk factors, atrial fibrillation, and chronic liver disease. In relation to HF itself, compared to the RICA historic cohort, the RICA-2 registry has more chronic patients than de novo patients, more patients in functional class II and fewer in functional class III according to the NYHA, more admissions and ED visits due to HF, and more patients with HF and reduced LVEF (HFrEF). On the contrary, there are no differences between the two registries for the most common aetiology of HF nor in the precipitating factor of decompensation. With regards to the baseline analytical variables, we have observed that RICA-2 patients have better kidney function values and lower NT-proBNP levels. In terms of HF treatment, an increase has been observed in patients treated with angiotensin receptor/neprilysin inhibitors (ARNI), aldosterone antagonists, and sodium-glucose cotransporter-2 (SGLT2) inhibitors. Lastly, we have not observed differences regarding mean hospital stay nor the percentage of patients undergoing follow-up in the HF Patient Comprehensive Care Unit (UMIPIC as per the Spanish acronym).

Table 4 lists the variables that are only recorded in the RICA-2 registry and were not recorded in the RICA historic cohort. In terms of frailty, the median of the scales used to assess this variable show that the majority of patients are pre-frail (2 points on the FRAIL scale) or vulnerable (stage 4 in the Clinical Frailty Scale). On the other hand, the mean score from the nutritional screening scales shows that the majority of patients are at risk of malnutrition. With respect to mortality risk, estimated by the EPICTER palliative care score, the mean score of 5 points indicates that the risk of mortality at 6 months is at least moderate. As far as amyloidosis, of the 280 patients presenting with left ventricular hypertrophy (defined as an interventricular wall or superior posterior wall thickness greater than 12 mm), 138 (49%) of them also present one or more diagnostic criteria for suspicion as defined by the European Society of Cardiology.31

Lastly, in terms of congestion, all patients are assessed for congestion using clinical variables (a mean score of 8 points on the EVEREST scale indicates moderate congestion), and additional assessments are conducted in 30% of patients using pulmonary and vena cava ultrasound. Most patients are treated with intravenous loop diuretics, preferably by bolus. In some cases, it is necessary to combine these with other diuretics, with the most frequently used being thiazide (21%), followed by acetazolamide (9%), and aldosterone antagonists at diuretic doses (5%). Some 7% of the patients are treated with hypertonic saline solution plus furosemide as a decongestive strategy and up to 30% with intravenous iron. Few patients require haemodynamic support, non-invasive ventilation, device implants, or surgery.

The inclusion of the first 1000 patients in the RICA-2 registry shows us that patients with HF treated in IM departments continue to be older patients with multiple comorbidities and with adequate representation between the sexes, something which is not always true for all observational studies or in HF clinical studies, where women are often under-represented.33,34 The most common type of HF according to LVEF in IM departments remains HFpEF7 though it is notable that compared to the historic cohort, there is an increase in patients with HFrEF. Despite the logical similarities between the RICA historic cohort and the contemporary RICA-2 cohort, some differences have been observed. Some of these can be justified, in part, by the fact that RICA-2 includes stable patients enrolled via out-patient services (which was not true for RICA) and perhaps for this reason there are more patients in NYHA functional class II, with better baseline kidney function, and with lower natriuretic peptides levels. Other differences are due to therapeutic advances that HF was undergone in recent decades with the appearance of ARNIs for HFrEF and SGLT2i for the whole spectrum of LVEF. For this reason, the prescription of these medications has clearly increased in RICA-2, as has another of the four pillars of HFrEF treatment, namely aldosterone antagonists. In terms of congestion, it is notable that this is increasingly more assessed via clinical ultrasound as a supplement to the physical examination, though solid scientific evidence is still lacking to be able to recommend its use as a guideline for decongestion.35 We must also highlight that one third of patients receive furosemide doses of 80 mg or higher, which could be a surrogate marker of diuretic resistance22 and could justify the use of early combined diuretic therapy as indicated in the results of recent clinical trials.36,37 Something new that the RICA-2 registry should provide is the assessment of other dimensions not evaluated in the RICA registry and perhaps less examined to date, such as frailty, nutrition and their impact on patients prognosis.38,39

Regarding patient prognosis (mortality and re-hospitalisation), it is still early to tell whether RICA-2 patients will have a better or worse prognosis than those from RICA, as a large number of patients are yet to be included, as well as full follow-up completed, to be able to make this assessment. It is noteworthy that the percentage of patients being monitored by UMIPIC has increased by 40%, a care model that has shown excellent benefits for the entire spectrum of HF patients.12,40–42

The major strength of RICA-2 is its representation of HF patients treated in real clinical practice in internal medicine, including patients with chronic and acute HF. As the number of patients included in RICA-2 increases and as its follow-up period does too, it will be possible to better know the clinical situation, respond to new questions, and generate new hypotheses. On the other hand, RICA-2 has the same limitations as all observational studies and registries, offering a lower level of scientific evidence than that provided by clinical trials, despite which it still provides valuable supplementary information.3,4

In conclusion, the RICA-2 registry represents a contemporary cohort of patients that provides us with clinical, epidemiological, and prognostic information about patients with HF, both chronic and acute, treated in IM departments.

This research did not receive any specific funding from agencies from the public sector, commercial sector, or not-for-profit organisations.

The authors declare that they do not have any conflicts of interest.