Clinical Research Directory

PrEcision Pacing in HFpEF: the PEP-HFpEF Trial

The PEP-HFpEF study is a prospective, single-center mechanistic study evaluating personalized heart rate pacing (myPACE) in patients with heart failure with preserved ejection fraction (HFpEF) and existing cardiac physiologic pacemakers. Participants will undergo sequential periods of standard and personalized pacing with serial physiologic assessments to evaluate the effects of myPACE on exercise capacity, cardiac function, biomarkers, quality of life, and clinical outcomes.

Finerenone's Impact on Cardiac Electrical Stability in HFpEF

To evaluate the efficacy of finerenone in reducing the incidence of any electrical instability or arrhythmias in the form of new-onset atrial fibrillation or atrial flutter (AFF), atrial tachycardia, extrasystoles (premature atrial and ventricular contractions, PACs and PVCs, respectively), ventricular arrhythmias, bradycardia, in patients with heart failure with preserved ejection fraction who are in sinus rhythm.

Dancing as an Alternative to the Traditional Exercising in Older Adults With Cardiac Diseases

According to the Global Burden of Disease Study (2017) 64 million people worldwide are living with Heart Failure (HF). Risk factors of HF include age, history of coronary heart disease, atrial fibrillation, hypertension, diabetes mellitus, smoking and low physical activity. There is clear evidence that regular physical activity can increase life expectancy and improve cognitive function, and delay functional disabilities associated with aging. Physical Activity and exercise training is considered as one of the components cardiovascular disease prevention and rehabilitation program. There is a growing scientific support that cardiac rehabilitation (CR) slows, stabilizes or regresses cardiovascular disease (CVD). In addition, it has been shown that CR programs significantly reduce re-hospitalisation and death from CVDs by up to 25%. Despite of strong evidence of the positive effects of exercise training in Chronic HF patients, the adherence to the exercise component of CR is still not at the level recommended by the international physical activity guidelines. Patients participating in physical activity programs are faced with several obstacles, such as orthopaedic limitations to exercise, or being severely overweight. Another most common barriers for participating in CR are family and employment obligation, psychological well-being and age ("CR is only for adults"). Participation of older adults in physical exercises programs is highly influenced by their personal interest in activity type, engagement and perceived advantages. The author is also mentioned that engaging in different types of activities or adding new elements to the traditional exercises may increase and maintain individuals' interest and engagement in physical activity. This will improve their commitment t the regular exercise and leading to improved health outcomes. World Health Organisation defines dance as a type of physical activity and recommends its implementation to develop physical skills, especially in the least active population groups. Scientists highlight the advantages of dancing over traditional strength and balance exercises that are often performed individually, whereas dance is predominantly a group activity. According to the Ministry of Culture of the Republic Azerbaijan, Azerbaijani traditional dances represent the ancient culture of the country and are popular activity among both young and older people. Azerbaijani dancing has a major social role in bringing people together during celebration of National Holidays and family events. However, use of traditional dancing in general, and Azerbaijani dances particularly, as an intervention in CR programs has not been well established. Screening of reports published since 2015, revealed only randomized control studies which identified the dance intervention as national/cultural dancing style. All those studies demonstrated positive impact of traditional dancing on the functional capacity and psychological condition of people with chronic diseases. More research on the use of the cultural dancing as an alternative to traditional exercise programs as a part of CR could provide clearer evidence about the role and effectiveness of traditional dance in CR. The aim of this research is to investigate the impact of Azerbaijani Cultural Dances on cardiorespiratory fitness and quality of life of patients with chronic HF.

eHealth Lifestyle Intervention To Enhance Outcomes in HFpEF

The goal of this clinical trial is to learn if a digital lifestyle education program improves exercise capacity in adults who have heart failure with preserved ejection fraction (HFpEF) and overweight or obesity. HFpEF is a type of heart failure in which the heart muscle is stiff and does not relax well, even though its pumping strength looks normal. The main questions it aims to answer are: * Does the program improve how much oxygen participants can use during exercise, a measure of fitness, after 6 months? * Does the program improve participants' quality of life and help them lose weight? Researchers will compare a group that uses the digital program plus usual care to a group that receives usual care alone. This will show whether the program adds a benefit. Participants will: * Be placed by chance into one of the two groups * Use a study website with short videos on exercise, healthy eating, and managing stress (program group), with new content every week for 6 months * Have exercise tests, an ultrasound scan of the heart, blood tests, and complete a quality-of-life questionnaire at the start and after 6 months Both groups will keep taking their usual heart failure medicines.

Selenium Intervention Registry Randomized Trial in Heart Failure

Heart failure is a serious condition in which the heart is unable to pump blood effectively, and it remains a leading cause of hospitalization and death worldwide despite advances in treatment. Selenium is an essential micronutrient that plays an important role in cellular energy production, antioxidant defense, and overall cardiovascular function. Low selenium levels are common among patients with heart failure in Northern Europe, and observational studies have shown that selenium deficiency is associated with an increased risk of hospitalization and death. In cases of severe deficiency, such as in Keshan disease, heart dysfunction can be reversed with selenium supplementation, suggesting a potential causal relationship. However, it is not yet known whether selenium supplementation can improve clinical outcomes in patients with heart failure when added to standard medical therapy. The SIRI-HF trial is a randomized, placebo-controlled study designed to evaluate whether daily supplementation with 200 micrograms of selenium, in addition to guideline-directed medical therapy, improves outcomes in patients with heart failure. The primary endpoint is a composite of recurrent heart failure hospitalizations and cardiovascular death. Secondary endpoints include all-cause mortality, changes in symptoms and functional status, and safety outcomes. This study will include patients from Sweden and Norway and aims to determine whether correcting selenium deficiency can improve prognosis in heart failure.

OBESE-HFpEF: Towards Preventing Obesity Related HFpEF

Obesity, severe overweight, is a growing problem worldwide and increases the risk of heart failure, especially a type called heart failure with preserved ejection fraction (HFpEF). In HFpEF, the heart becomes stiffer. This makes it harder for the heart to fill with blood, which can lead to shortness of breath during physical activity. In the Netherlands, 15% of the population has obesity. In South Limburg, this is even higher at 19%. Among people with HFpEF, obesity is much more common: about 50% of these patients have obesity. Life expectancy in people with HFpEF is poor, and current treatment mainly focuses on reducing symptoms. Early recognition and treatment of risk factors, such as obesity, are therefore very important. This study includes about 250 people with obesity. Using a heart ultrasound and tests of blood and fat tissue, we will look for early signs of HFpEF and study the effects of weight loss. The measurements will be repeated after 1 and 2 years. The goal of this study is to better understand how obesity contributes to HFpEF and how weight loss affects the heart. This research may help improve future treatments for patients with HFpEF.

Investigation on the Impact of Finerenone on Myocardial Remodeling in Patients With Diabetic Kidney Disease and Heart Failure

The goal of this clinical trial is to evaluate the impact of Finerenone on myocardial remodeling in patients with diabetic kidney disease (DKD) and heart failure with a left ventricular ejection fraction (LVEF) ≥ 40%. The main questions it aims to answer are: 1. Does 6-month treatment with Finerenone significantly reduce myocardial fat infiltration (measured by MR Spectroscopy) and myocardial fibrosis (measured by extracellular volume fraction on CMR)? 2. Does Finerenone improve global left ventricular longitudinal systolic strain (GLS) and other structural remodeling indices in this patient population? Researchers will compare cardiac imaging parameters after 6 months of treatment to baseline values to see if Finerenone effectively reverses or slows down pathological cardiac changes. Participants will: 1. Take Finerenone (Kerendia) 10 mg or 20 mg orally once daily for a total of 6 months. 2. Undergo advanced cardiac imaging, including Cardiac Magnetic Resonance (CMR) and MR Spectroscopy (MRS), at the beginning of the study and after 6 months of treatment. 3. Receive regular clinical follow-up and blood tests to monitor safety (such as potassium levels and kidney function) and treatment efficacy.

Frailty and Outcomes in Older Heart Failure Patients With Ejection Fraction >40%

This study aims to investigate the prevalence of frailty and its association with six-month clinical outcomes in elderly patients with heart failure and left ventricular ejection fraction greater than 40%. Elderly patients diagnosed with heart failure will be assessed for frailty status and followed up for six months to evaluate outcomes such as hospitalization and mortality. The study is observational and will help improve understanding of the impact of frailty on the prognosis of heart failure patients with ejection fraction \>40%.