Heart Failure Clinical Trials

The focus of this study is to test the efficacy of a 12-week, phone-delivered Positive Psychology-Motivational Interviewing (PP-MI) intervention, with additional twice weekly PP and health behavior text messages for a total of 24 weeks (with interactive, algorithm-driven, goal-focused text messages in the final 12 weeks), compared to an attention-matched MI-based educational condition, in a randomized trial (NIH Stage II) of 280 patients with New York Heart Association class I-III Heart Failure (HF). Read Less

The goals of this project are to determine the effectiveness of acute (2 hours after a single dose) and chronic (after 6 weeks of once-a-day dosing) KNO3 treatment (10mmol) vs. placebo on quadriceps muscle power and on aerobic exercise performance (V̇O2peak) in patients with HFrEF (left ventricular ejection fraction \<45%). The investigators hypothesize that both acute and chronic dosing of 10mmol of KNO3 will improve exercise performance in HFrEF. To test this hypothesis, the investors will perform a randomized, double-blind, placebo-controlled, parallel-arm design study. Read Less

Recent medical guidelines for the management of heart failure (HF) have established a combination of specific classes of medications as the best treatment for patients with heart failure with reduced ejection fraction (HFrEF). However, studies have shown that these medications, known together as guideline-directed medical therapy (GDMT), are not being used in clinical practice less often than they could be. Several tools to promote broader use of these treatments (including patient checklists) have shown promise for increasing use of GDMT. However, these tools have not been broadly implemented within large health systems. The goal of this study is to see if using these tools broadly within cardiology clinics will increase the use of GDMT. This study is important because it could help improve the use of GDMT, which may lead to improved patient care and outcomes. Read Less

This study examines the role of the epidermal growth factor (EGF) receptor family and the EGF family of ligands in the regulation of non-myocytes isolated from the human heart. Read Less

The goal of this factorial randomized trial is to examine the independent and synergistic efficacies of two mobile health technology interventions in people with chronic heart failure. The first intervention involves the use of multiple consumer mHealth apps and sensor devices (MyApps) for heart failure self-care (maintenance, monitoring, and management). The second intervention is a program of tailored text messages (Text4HF) targeting modifiable behavioral factors associated with heart failure self-care non-adherence. The main questions this study aims to answer are: 1. Can the use of consumer mHealth apps and devices (MyApps) improve heart failure self-care and reduce days lost due to cardiovascular hospitalization or death for any cause? 2. Can a program of individually tailored text messages (Text4HF) improve heart failure self-care and reduce the days lost due to cardiovascular hospitalization or death for any cause? 3. Can MyApps and Text4HF combined lead to greater improvements in heart failure self-care and days lost due to cardiovascular hospitalization or death for any cause Read Less

The goal of this study is to better understand the effects of a sodium-glucose transport protein 2 inhibitor, dapagliflozin, added on to standard of care on heart and lung function and circulating metabolites (substances created when our bodies break down food, drugs, or its own tissues) in patients with chronic kidney disease. Read Less

Study Design: This is an international, multicenter, observational, non-interventional, prospective, blinded, single-arm, two-period study, to collect patient utterances that will be retrospectively analyzed to determine the sensitivity and UPNR of the HearO system. Read Less

This research study is being done to compare the effectiveness two drugs: an extended release torsemide (ERT) versus generic immediate release Torsemide (IRT) in reducing the worsening of symptoms of Overactive Bladder (OAB i.e., frequency, urgency, or urgency incontinence) in patients with chronic congestive heart failure (CHF). This study will include CHF patients who experience worsening OAB) symptoms with use of a loop diuretic. The total duration of the study is about eight weeks with a total of nine visits. There will be a screening visit that lasts one to two hours. The screening visit includes history and physical exams, blood draws, and urine analysis. If eligible for the study, participants will receive either generic torsemide or extended release torsemide for the first four weeks. Participants will do a virtual research visit on week one, two and three to submit a symptom diary and answer a questionnaire about urinary symptoms. At four weeks, history and physician exam will be done and blood will be collected. Participants will be assigned to receive either extended release torsemide (if they initially received generic torsemide) and generic torsemide (if they initially received extended release torsemide) for the next four weeks. Participants will attend virtual research visits on week five, six and seven to submit a symptom diary and answer a questionnaire about urinary symptoms. At the end of the study in week eight, they will have history and physical exams and blood draws. Some risks from the study may include side effects of torsemide like acute kidney injury, fluid/electrolyte loss, hypersensitivity reactions and reversible hearing loss/tinnitus. Read Less

The Microtech-LVAD study is designed as a prospective, single arm, multi-center early feasibility study. Approximately 15 patients will be enrolled in the study. The study will be limited to patients in whom it is decided, based on routine clinical practice, that the LVAD will be implanted via a midline sternotomy. In the first 5 study patients, the device will be implanted in the RA; subsequently, the device will be implanted in the LA unless the patient is deemed at high risk of post-LVAD right heart failure, in which case the device will be placed in the RA Read Less

The goal of PEER-Heart is to implement and assess feasibility and preliminary effectiveness of a community peer-facilitated screening for methamphetamine-associated heart failure (MAHF) and linkage to evidence-based cardiology care for people who use methamphetamine in rural areas. Read Less

EAGLE-HF (Early Assessment and initiation of GuideLine-directed Evidence-based management-HF) is a prospective single site study of a multinational, unblinded, randomized-controlled, longitudinal trial called SYMPHONY. Primary, secondary and exploratory outcomes that are part of SYMPHONY are not described herein as they replicate SYMPHONY outcomes. Data associated with SYMPHONY outcomes will be sent to the SYMPHONY coordinating center. In EAGLE-HF, site investigators will examine if a new-onset heart failure (HF) diagnosis are asscoiated with social determinants of health (6 factors), social vulnerability index and distressed community indices. In addition, for patients diagnosed with HFrEF, prescribing patterns (use of and dose of) core HF medications will be assessed for association with physician practice type and medical provider type. Finally, (among participants in the SYMPHONY Active arm, an optimal NTproBNP cut-point will be assessed for diagnosis of HF based on social determinants of health, social vulnerability index, distressed community index, HF risk factors and medical comorbidities. Read Less

The study investigators are interested in learning more about how drugs, that are given to children by their health care provider, act in the bodies of children and young adults in hopes to find the most safe and effective dose for children. The primary objective of this study is to evaluate the PK of understudied drugs currently being administered to children per SOC as prescribed by their treating provider. Read Less