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Heart Diseases clinical trials

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NCT ID: NCT05503810 Terminated - Feasibility Clinical Trials

Social Support Intervention Targeting Patients Treated for Cardiac Disease Who Experience Loneliness

Start date: October 5, 2022
Phase: N/A
Study type: Interventional

Introduction: In patients treated for cardiac disease, loneliness is known to contribute negatively to health behavior, health outcome and increase risk of cardiac and all-cause mortality. Even so, in health care research, social support interventional studies targeting patients who experience loneliness is lacking. Aim: To determine the feasibility of an individually structured social support intervention targeting patients treated for cardiac disease who experience loneliness. Design: A feasibility study based on randomized clinical trial design with 1:1 randomization to a 6-month social support program, plus usual care (intervention) versus usual care, (i.e., regular guidelines-based follow-up). Intervention: Patients classified as high risk lonely according to the High Risk Loneliness tool will be provided with an informal caregiver in the six months rehabilitation phase following cardiac disease treatment. The informal caregiver will be designated by the patient from the existing social network or a peer, depending on patients' preferences. The core content of the intervention is through nurse consultations at baseline, one, three and six months, to enhance and reinforce the informal caregiver's competences to be a social support resource. The theoretical framework of the nurse consolations will be based on Middle-range theory of self-care. Outcome: Feasibility will be evaluated in terms of acceptability and adherence according to predefined feasibility criteria. The preliminary effect of the intervention on patient-reported outcomes, health behaviors and health outcomes will be evaluated in the intervention and the control group at baseline, one, three, six and twelve months.

NCT ID: NCT05429307 Terminated - Heart Diseases Clinical Trials

Turkish Adaptation, Validity and Reliability of Exercise Sensitivity Questionnaire

Start date: May 1, 2022
Phase:
Study type: Observational

Interoceptive complex sensations and fear beliefs resulting from cardiac risk factors or cardiovascular disease can further increase one's awareness and attention to bodily situations and cause differences in the interpretation of somatic sensations. These intraceptive somatic sensations may be the underlying factors for participation in exercise and compliance with exercise programs No Turkish questionnaire evaluating unpleasant sensations (Exercise sensitivity) was found. Exercise Sensitivity Questionnaire, which we planned to validate in our study, is a questionnaire developed by Samantha Farris et al. in 2020 to measure anxiety, exercise avoidance behavior and exercise sensitivity, which are frequently observed in individuals with heart disease.

NCT ID: NCT05409183 Terminated - Heart Failure Clinical Trials

Effectiveness of CRD-740 in Heart Failure

CARDINAL-HF
Start date: May 26, 2022
Phase: Phase 2
Study type: Interventional

This is a two-part study evaluating the effectiveness of CRD-740 in patients with either Heart Failure with Reduced Ejection Fraction (HFrEF) or Heart Failure with Preserved Ejection Fraction (HFpEF) after 12 weeks of treatment. The primary objective in Part A is to assess the effect of CRD-740 compared to placebo in plasma cGMP at Week 4. The primary objective in Part B is to determine whether CRD-740 reduces NT-proBNP compared to placebo at Week 12.

NCT ID: NCT05314868 Terminated - Clinical trials for Congenital Heart Disease

Retrospective Evaluation of Photo-oxidized Decellularized Bovine Pericardium in Cardiac Repair or Reconstruction Surgery

Retro-C
Start date: March 31, 2022
Phase:
Study type: Observational

The objective of this postmarket, retrospective, single center study is to evaluate the clinical outcomes of patients who have received PhotoFix® Decellularized Bovine Pericardium (PhotoFix) as a patch within a cardiac surgical repair or reconstruction procedure. PhotoFix is prepared from bovine pericardium, which is stabilized using a dye-mediated photo-oxidation process and sterilized using aseptic processing techniques.

NCT ID: NCT05157568 Terminated - Cardiac Disease Clinical Trials

Pilot Randomized Clinical Trial of Live-streamed Cardiovascular Rehabilitation

VirtualEX
Start date: September 20, 2022
Phase: N/A
Study type: Interventional

Cardiovascular Rehabilitation (CR) programs are designed to help people recover following a heart attack, heart surgery, or diagnosis of heart disease. Counseling, education, risk factor management, and efforts to increase levels of MVPA constitute the largest components of CR programs. Technological advances in video-conferencing and video-streaming are affording new opportunities to increase access to CR services and supervised exercise sessions for patients who are social distancing, or who face access issues (e.g., time, mobility, transportation etc.). Comfort with these technologies for CR staff and patients has been accelerated by the current pandemic. Technology-enabled interactions between patients and providers is a significant opportunity to help mitigate these effects. We developed a new model for delivery of group exercise training for people with heart disease. Our model delivers all the core components of CR (i.e. counseling, education, risk factor management) but also includes live-streaming of CR exercise classes. Two versions of these classes are available: one that does not require any exercise equipment; and one that relies on a stationary exercise bike and exercise band delivered and installed in patients' homes. The new model has performed well in proof-of-concept testing, but now needs to be rigorously evaluated.

NCT ID: NCT05112731 Terminated - Clinical trials for Myocardial Infarction

Role of Glycation and Inflammation in Acute Ischemic Heart Disease

AGLIANICO
Start date: February 1, 2022
Phase:
Study type: Observational

This study requires the consecutive enrollment of 60 patients following the first event of acute myocardial infarction, evaluating B-Cell Activating Factor (BAFF) and methylglyoxal (MGO) levels in the acute setting (pre-reperfusion) and 3 months after reperfusion.

NCT ID: NCT05018247 Terminated - Clinical trials for Ischemic Heart Disease

Early Revascularization in Stable Ischemic Heart Disease Using P.E.T. Imaging

PETREVASC
Start date: May 4, 2021
Phase: N/A
Study type: Interventional

To compare the impact of revascularization and Optimal Medical Treatment (OMT) on the extent of severely reduced coronary flow capacity in stable ischemic heart disease.

NCT ID: NCT04768634 Terminated - Clinical trials for Congenital Heart Disease

Predicting Arrhythmogenic Risk in Congenital Heart Patients: the PRECISION Study

Start date: March 23, 2021
Phase: N/A
Study type: Interventional

In this research study we want to learn more about abnormal heart rhythm after cardiac surgery in children. These abnormal heart rhythms, also called arrhythmias, may occur due to several reasons after cardiac surgery. They can be due to abnormal electrical pathway or an irritable area of the heart that stimulates abnormal impulses. Regardless of the cause, arrhythmias after cardiac surgery can be a problem, extending the hospital stay, requiring additional medications and even leading to cardiac arrest. Current practice is to monitor for arrhythmias after cardiac surgery, and to treat them if they occur. With this research, we want to investigate whether we can identify patients who will develop arrhythmia, and treat them before they occur.

NCT ID: NCT04445103 Terminated - Clinical trials for Cardiovascular Diseases

The Malaria Heart Disease Study

Start date: June 21, 2020
Phase:
Study type: Observational

The Malaria Heart Disease Study is a prospective longitudinal cohort study of a random sample of approximately 1200 individuals from the state of Acre in Brazil. The overall hypothesis is that patients who have (i) previously suffered from a malaria infection or (ii) patients with ongoing symptomatic malaria will benefit from having an echocardiogram and blood tests performed as a screening tool to diagnose early cardiac impairment and prevent future cardiovascular disease.

NCT ID: NCT04434001 Terminated - Clinical trials for Congenital Heart Disease

ZEPLAST- PED: ZEro_PLASma Trial in Small Infants Undergoing Cardiac Surgery

ZEPLAST-PED
Start date: February 27, 2020
Phase: Phase 2
Study type: Interventional

In pediatric patients (newborns and infants weighing less than 10 kg) undergoing cardiac surgery with extracorporeal circulation postoperative bleeding represents a known complication with a significant impact on outcome. Fresh frozen plasma (FFP) for bleeding management is associated, particularly in this kind of patients, to volume overload and a significative increase of Transfusion Related Acute Lung Injury (TRALI), further worsening the postoperative outcome. In the adult patient FFP employment could be almost completely canceled by administration of concentrated hemostatic components - the fibrinogen concentrate and prothrombin complex concentrate (PCC). We designed this phase II pilot study to establish whether an analogous strategy, modified accordingly to pediatric physiology, could be safely and successfully applied in newborns and infants.