Efficacy of controlvit as a complementary strategy in reducing hospitalizations in patients with heart failure. Randomized clinical trial

Abstract

Abstract Introduction In patients with heart failure, the main cause of hospital admissions is due to episodes of decompensation, which are associated with an increase in the costs and resources needed for care; they have a negative impact on the quality of life and prognosis of the disease. Therefore, it is necessary to design, evaluate and implement alternatives to achieve efficient follow-up and monitoring, improving adherence to treatment and helping identify decompensation episodes that facilitate their early treatment, so new hospital admissions can be avoided. For this reason, the use of information and communication technologies (apps) is emerging as an excellent strategy for the possibility of improving coverage, real-time monitoring and timeliness of care. ControlVit® is an electronic application that allows permanent, real-time monitoring of biomedical measurements for early detection of complications. Objective To determine the efficacy of ControlVit® as a complementary strategy in reducing hospital admissions in patients in a heart failure program. Methodology A randomized, placebo-controlled, open-label clinical trial was conducted, (n=140), included patients with heart failure under controlled clinical follow-up in a structured heart failure program, into NYHA FC II–IV, capable of handling smartphones and with permanent internet connectivity. All patients were provided with educational elements, a scale and a blood pressure monitor to enter clinical data and a symptom questionnaire necessary for follow-up. The patients were randomized to 2 groups: intervention: use of ControlVit® vs. placebo, with a 6-month follow-up. The primary outcome was the difference in readmissions for heart failure between the 2 groups. Patients on the waiting list for heart transplantation or use of ventricular assist devices were excluded. All participants signed informed consent and the protocol was approved by the institutional ethics committee. Results A total of 140 patients were included in the study (intervention = 71, placebo = 69), with an average age of 66 years, 71% were men, the main etiology of heart failure was ischemic (60%), the main comorbidities were arterial hypertension (44%), dyslipidemia (42%), hypothyroidism (38%), chronic kidney disease (38%), and diabetes mellitus (27%). During follow-up, there were 6 deaths (3 in each group) and 17 readmissions (3 in the intervention group and 14 in the control group). After adjustment for comorbidities, HR 0.72 CI95 (0.52; 0.92), p=0.0325 was found. Conclusion In patients with heart failure, ControlVit® is a useful and complementary tool for follow-up, which reduces hospital admissions due to episodes of decompensation. Funding Acknowledgement Type of funding sources: Other. Main funding source(s): German Saldarriega award.Javeriana University