Clinical Research Directory

Social Prescribing to Improve Adherence and Outcomes in Women With Heart Failure

Background: Heart Failure (HF) is the second most common cause of hospitalizations for women in North America. Non-adherence to guideline-directed medical therapy (GDMT) is associated with 50% of all treatment failures and high rates of hospitalizations and death. A recent Canadian study showed that adherence to three or more GDMT medications occurred in only 20% of Canadian HF patients. Despite clear guidelines on the pharmacologic management of HF and the introduction of new and effective drugs, adherence to GDMT in women with HF is low. Furthermore, the rates of hospitalizations have not improved in Canada over the last decade, and mortality in Canadian women with HF remains high. One explanation may be that social determinants of health (SDOH), which are known to be strong predictors of both adherence and adverse outcomes in HF, have not specifically been targeted to improve either adherence or outcomes in HF. Social prescribing (SP) is an innovative, non-medical intervention that aims to improve health by addressing SDOH. However, whether using SP to LINK clinical and social services for the benefit of socially vulnerable HF women can improve outcome is unknown. By targeting SDOH, which are strong predictors of adherence and outcomes in HF, and which have been shown to disproportionately disfavor women, SP has the potential to significantly improve medication adherence, quality of life and outcomes in women with HF. Objectives: The overall aim of this study is to assess whether SP, through individualized, SDOH-targeted interventions, can improve adherence and quality of life in Canadian women with HF and at high risk for no adherence. Primary objective: To determine whether SP can improve adherence to GDMT. Secondary objective: To determine whether SP can improve quality of life. Methods: This is an intention to treat, multicenter (five centers), and open-labeled, randomized clinical trial. Women with HF with two or more points on a weighted SDOH questionnaire (SPARK tool) will be randomly assigned to either SP or control group. Women in the SP group will meet with a link worker (LW) who will perform SP. SP will consist of personalized referrals to non-medical supports or services based on women's specific SDOH-related vulnerabilities and social needs. SP will address social needs such as issues with income, unemployment, transportation, mobility, dependents, housing, loneliness, mental health, health literacy, medication management and medical appointment schedules. Social prescriptions will be based on the interview conducted by the LW and will prioritize SDOH-related vulnerabilities identified on the SPARK questionnaire. Participants in the control group will receive standard care as is typically offered in the current specialized HF clinic in the participating centers. Controls will not meet with a LW, but, as usual, their physician or treating team may refer them to any specialists or services deemed necessary. Outcome measures: The primary outcome will be adherence to GDMT measured with PDC obtained from provincial administrative databases and the secondary outcome will be quality of life measures including physical limitations, social limitations, as measured with the Kansas City Cardiomyopathy Questionnaire (KCCQ-12). Sample size Calculations: The sample size was calculated using the primary outcome of adherence to GDMT measured with PDC as a continuous variable. In one observational study on adherence to HF medications which compared women and males adherence using PDCs, adherence in women was 63% with a SD of 23%. The impact of an absolute increase of 10% in PDC on clinical end points was considered significant. Using an alpha of 0.05 and a power of 0.80, a minimum of 166 participants would be needed to detect a statistically significant difference. Based on pilot data, the proportion of women followed in heart failure clinics is 28% and the proportion of eligible women (i.e. 1 point or more on the SPARK questionnaire) is about 30%. Considering a 30% refusal rate and a 5% dropout rate (intention to treat with registry based outcome), the five chosen centers should totalize 188 participants. The secondary outcome, the KCCQ, is a continuous variable for which a change of five points or more (5%) is considered clinically significant. Using an alpha of 0.05 and a power of 0.80, 126 patients would be required to detect such a difference. Significance: SP holds immense potential for women with HF by addressing critical gaps in care. SP may help bridge the gap between healthcare providers and community resources, providing tailored support addressing SDOH that disproportionately affect women with HF. SP has the potential to significantly enhance adherence to GDMT, which has been shown to greatly, reduce hospitalizations and mortality in this vulnerable population.

Acquisition of Cardiac Function Parameters in MRI and Echocardiography in Patients with Ethyltoxic Liver Cirrhosis and Transjugular Intrahepatic Portosystemic Shunt (TIPSS) Placement

The aim of this clinical trial is to investigate the development of cardiac decompensation following transjugular intrahepatic portosystemic shunt (TIPSS) implantation in order to draw conclusions for future treatment methods or exclusion criteria prior to TIPS implantation. The main questions to be answered are: How often do symptoms of cardiac decompensation develop over a one year period? What laboratory, clinical or imaging morphological changes are associated with this? In addition to the standardised clinical procedure for TIPSS implantation, participants will undergo 3 cardiac magnetic resonance imaging (MRI), extended echocardiographic examinations (both just before, 3 days after and 3 months after implantation) and laboratory chemistry tests for specific endothelial and inflammatory markers (just before, on the day of implantation, 1 day after, 1, 3, 6 and 12 months after implantation).

COR-INSIGHT: Optimizing Cardiovascular and Cardiopulmonary Outcomes with AI-Driven Multiplexed Indications Using COR ECG Wearable

The COR-INSIGHT trial aims to evaluate the effectiveness of Peerbridge COR advanced ambulatory ECG wearables (COR 1.0 and COR 2.0) in accurately and non-invasively detecting cardiovascular and cardiopulmonary conditions using AI-based software (CardioMIND and CardioQSync). The study devices offer non-invasive, multiplexed, AI-enabled direct-from-ECG detection as a novel alternative to traditional diagnostic methods, including imaging, hemodynamic monitoring systems, catheter-based devices, and biochemical assays. Continuous COR ECG data collected in hospital, outpatient clinic, or home settings will be analyzed to evaluate the predictive accuracy, sensitivity, specificity, and performance of these devices in differentiating between screen-positive and screen-negative subjects. The panel of screened indications encompasses a broad spectrum of clinically relevant cardiovascular, cardiopulmonary, and sleep-related diagnostic parameters, which are critical for advanced patient assessment and management. In the cardiovascular domain, the protocol emphasizes the detection and classification of heart failure, assessment of ejection fraction severity, and identification of myocardial infarction, including pathological Q-waves and STEMI. It further addresses diagnostic markers for arrhythmogenic conditions such as QT interval prolongation, T-wave alternans, and ventricular tachycardia, as well as insights into ischemia, atrial enlargement, ventricular activation time, and heart rate turbulence. Additional parameters, such as heart rate variability, pacing efficacy, electrolyte imbalances, and structural abnormalities, including left ventricular hypertrophy, contribute to comprehensive cardiovascular risk stratification. In the non-invasive cardiopulmonary context, the protocol incorporates metrics like respiratory sinus arrhythmia, cardiac output, stroke volume, and stroke volume variability, providing critical insights into hemodynamic and autonomic function. The inclusion of direct-from-ECG metrics for sleep-related disorders, such as the apnea-hypopnea index, respiratory disturbance index, and oxygen saturation variability, underscores the protocol's utility in addressing the intersection of cardiopulmonary and sleep medicine. This multifaceted approach establishes a robust framework for precision diagnostics and holistic patient management. The COR 1.0 and COR 2.0 wearables provide multi-lead ECG recordings, with COR 2.0 offering extended capabilities for cardiopulmonary metrics and longer battery life (up to 14 days). COR 2.0 supports tri-modal operations: (i) Extended Holter Mode: Outputs Leads II and III, mirroring the functionality of COR 1.0 for broader ECG monitoring applications. (ii) Cardiopulmonary Mode: Adds real-time recording of Lead I, V2, respiratory impedance, and triaxial accelerometer outputs, providing advanced cardiopulmonary insights. (iii) Real-Time Streaming Mode: Streams data directly to mobile devices or computers via Bluetooth Low Energy (BLE), enabling real-time waveform rendering and analysis. The COR 2.0 units are experimental and not yet FDA-cleared. Primary endpoints include sensitivity (true positive rate) \> 80%, specificity (true negative rate) \> 90%, and statistical agreement with reference devices for cardiovascular, cardiopulmonary, and sleep metrics. Secondary endpoints focus on predictive values (PPV and NPV) and overall diagnostic performance. The study employs eight distinct sub-protocols (A through H) to address a variety of cardiovascular, cardiopulmonary, and sleep-related diagnostic goals. These sub-protocols are tailored to specific clinical endpoints, varying in duration (30 minutes to 14 days) and type of data collection. Up to 15,000 participants will be enrolled across multiple sub-protocols. Screening ensures eligibility, and subjects must provide informed consent before participation. Dropouts and non-compliant subjects will be excluded from final analyses.