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Heart Failure clinical trials

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NCT ID: NCT05460572 Enrolling by invitation - Heart Failure Clinical Trials

Cardiac Metabolic Profiling in the Fed State

CAMP
Start date: July 1, 2022
Phase: N/A
Study type: Interventional

This is a non-randomized interventional prospective study, aiming to provide insight into cardiac substrate utilization in the fed state. Patients will participate during an elective PVI procedure which would have taken place regardless of the current study. During this study, study subjects will receive peripheral parenteral nutrition (PPN) through an intravenous (iv) line. During the procedure, blood samples will be drawn from the catheters which will be in situ for the purpose of the elective PVI procedure. Cardiac arteriovenous (A-V) gradients of metabolites will be measured, reflecting cardiac uptake and release of metabolites in the fed state.

NCT ID: NCT05441696 Enrolling by invitation - Clinical trials for Congestive Heart Failure

Study for the Evaluation of a Non-invasive Hemodynamic Measurement in Heart Failure Patients

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

Track changes in non-invasive central venous pressure across hospital stay and relationship with readmission

NCT ID: NCT05390411 Enrolling by invitation - Decision Making Clinical Trials

Seeking Objectivity in Allocation of Advanced Heart Failure (SOCIAL HF) Therapies Trial

SOCIAL HF
Start date: March 6, 2023
Phase: N/A
Study type: Interventional

The primary goal of this study is to assess real-world effectiveness and implementation of an evidence-based multi-component strategy to achieve equity in the allocation rate of advanced heart failure therapies, heart transplants and ventricular assist devices. This study proposes to implement evidence-based strategies that reduce bias, replace subjective evaluations with objective criteria, and improve group dynamics in a randomized cluster trial. This rigorously designed trial may inform national guidelines for advanced heart failure therapy allocation, and data are likely to be generalizable to other organ replacement treatments and advanced chronic disease decision-making processes.

NCT ID: NCT05388019 Enrolling by invitation - Heart Failure Clinical Trials

Multidisciplinary Ventricular Assist Device Clinic

MultiVAD
Start date: May 2022
Phase: N/A
Study type: Interventional

Current standard of care for ventricular-assist device (VAD) patients is composed of a multidisciplinary team (MDT), which is required in pre-implant and implant hospitalization care but is lacking in post-implant care. Post-implant care is currently centered around the avoidance of complications of VAD support, including cerebrovascular insult (CVA/TIA), gastrointestinal bleeding and infection. Despite major improvements in survival for VAD patients, quality of life and physical functioning measures have not seen significant improvements. This study will include two prospective interventional cohorts and a retrospective control cohort. The first prospective interventional cohort will consist of patients who recently underwent LVAD implantation at Massachusetts General Hospital, and their caregivers. These patients will receive only multidisciplinary team care from the time of their implant. The second prospective interventional cohort will consist of patients who have previously undergone LVAD implantation at Massachusetts General Hospital who are being followed-up with standard-of-care VAD clinic visits, and their caregivers. These patients will receive a hybrid of multidisciplinary team care and standard-of-care visits. The historical control cohort will consist of retrospective data collection on patients who have undergone LVAD implantation in the past and no longer have an LVAD implanted (due to transplant, death, explant, etc.), and will be matched with the prospective interventional patients. The purpose of this study is to characterize the impact of routine MDT care on health-related quality of life, caregiver burnout and functional capacity of outpatient VAD patients, and to determine if implementation of MDT care is associated with a reduction in complications and readmissions in VAD patients at one- and two-years post implant. The investigators hypothesize that the MDT clinic model in addition to standard of care VAD management will positively impact the quality of life and functional status of VAD patients. Subjects who consent to this study will be seen by the MDT providers and complete Cardiopulmonary Exercise Tests (CPET), six-minute-walk-tests, and quality of life questionnaires. The primary caregivers of these subjects will complete a Caregiver Self-Assessment at two timepoints. We anticipate to enroll 20 newly-implanted VAD patients in the pure-MDT arm, 35 pre-existing VAD patients in hybrid-MDT/SOC arm, and 55 primary caregivers.

NCT ID: NCT05374291 Enrolling by invitation - Heart Failure Clinical Trials

The RENAL LIFECYCLE Trial: A RCT to Assess the Effect of Dapagliflozin on Renal and Cardiovascular Outcomes in Patients With Severe CKD

Start date: November 8, 2022
Phase: Phase 3
Study type: Interventional

Rationale: Sodium glucose co transporter 2 (SGLT2) inhibitors are a relatively new class of agents, originally developed as oral antihyperglycemic drugs. SGLT2 inhibitors are clinically available since 2012 for the treatment of patients with diabetes mellitus type 2. Later, SGLT2 inhibitors appeared to have also specific reno- and cardioprotective effects. Remarkably, the trials that have been performed thus far excluded patients with an eGFR below 25 mL/min/1.73m2 at inclusion, prevalent dialysis patients, and kidney transplant recipients. This is unfortunate, because especially these patients are at high risk of reaching kidney failure requiring dialysis, cardiovascular complications and mortality, whereas there are only few proven effective therapies. There is emerging evidence from experimental studies and post hoc-analyses of randomized clinical trials that SGLT2 inhibitors may also be effective in preventing cardiovascular and mortality outcomes in these patients with severe CKD, including patients receiving dialysis or living with a kidney transplant. For instance, subgroup analysis of the DAPA-CKD trial comparing 624 patients with an eGFR<30 to the remainder of the trial population with better kidney function, demonstrated that the efficacy of the SGLT2 inhibitor dapagliflozin in reducing cardiovascular, heart failure and renal outcomes persisted in the population with impaired kidney function. Furthermore, in the DAPA-CKD trial patients continued to use dapagliflozin or placebo when dialysis was initiated. In the subgroup of patients who initiated dialysis, dapagliflozin was associated with a relative risk reduction for mortality of 21%. Finally, in kidney transplant recipients, SGLT2 inhibitors have been shown to be effective in lowering HbA1c, body weight, blood pressure and stabilize kidney function, and these agents were well tolerated and safe. Taken these findings together there is a sound rationale to study the long-term reno- and cardioprotective efficacy and safety of SGLT2 inhibitors in patients with severe CKD. There are two cardiac sub-studies: the cardiac MRI substudy and the echocardiography sub-study. The echocardiography sub-study is referred to as the "SGLT-2-inhibitors to Target Heart Failure in Peritoneal Dialysis" (STOP HF in PD) study. In STOP HF in PD the effect of dapagliflozin on cardiac function will be assessed in a subset of 100 patients treated with peritoneal dialysis.

NCT ID: NCT05255172 Enrolling by invitation - Clinical trials for Heart Failure New York Heart Association (NYHA) Class III

Exercise Intervention in Patients With Heart Failure With Preserved and Reduced Ejection Fraction

Start date: June 1, 2022
Phase: N/A
Study type: Interventional

The objective of this study is to assess by what physiological mechanisms patients with heart failure benefit from exercise. Effects of an exercise intervention will be assessed for both central (heart and lungs) and peripheral (muscle fiber and mitochondria) factors.

NCT ID: NCT05253469 Enrolling by invitation - Heart Failure Clinical Trials

Infective Endocarditis Surgery Using Conventional Prosthetic Valves Versus Cryopreserved Aortic Homograft

IESCOPHO
Start date: February 14, 2022
Phase:
Study type: Observational

: Evidence suggested that autologous or allogeneic tissue is more suitable to synthetic material in an infected field. Given the unwillingness of some surgeons to use artificial foreign materials, such as conventional mechanical or stent xenograft valve prostheses, cryopreserved aortic homografts (CAH) have been recommended revealing favorable outcomes in aortic valve endocarditis (AVE) surgery (1-5). This aspect is even more evident in cases involving prosthetic valve endocarditis (PVE) and other complex and aggressive lesions involving the aortic root and intervalvular fibrosa with abscess formation. However, most of these reports are fixed on single-arm observational studies without comparing CAH with conventional prostheses. The key question of this study is to establish the difference in treatment failure (death, recurrent aortic valve regurgitation and reoperation), all-cause and cause-specific (cardiac vs noncardiac) mortality, hospitalizations for heart failure during follow-up (structural/non structural valve deterioration, thromboembolism and recurrent endocarditis) in patients who received the CAH vs conventional mechanical or stent xenograft valve prostheses for aortic valve replacement (AVR) secondary to infective endocarditis (IE)

NCT ID: NCT05224557 Enrolling by invitation - Heart Failure Clinical Trials

Analysis of Cardiac Biomarker Racial Discrepancies

Start date: September 15, 2021
Phase:
Study type: Observational

The goal is to review cardiac biomarkers present on admission between African American patients with new onset Heart Failure compared to a comparable cohort of Caucasian patients to establish whether there is a clinically significant difference between the two groups regarding cardiac biomarker levels and initial Heart Failure severity. Hypothesis: Cardiac biomarker levels in African American patients with new onset Heart Failure with Reduced Ejection Fraction will be significantly lower than a Caucasian cohort with new onset Heart Failure with Reduced Ejection Fraction.

NCT ID: NCT05223751 Enrolling by invitation - Clinical trials for Diastolic Heart Failure

Parasympathetic Augmentation Via Respiratory Training for Patients With Systolic Heart Failure

PART-HF
Start date: February 7, 2022
Phase: N/A
Study type: Interventional

This is a prospective, randomized, controlled clinical trial in which participants with NYHA class II or III and symptomatic Heart Failure with reduced Ejection Fraction (HFrEF) (Ejection Fraction (EF) ≤ 45%) will be assigned to one of two treatment groups: standard of care or breathing therapy.

NCT ID: NCT05205265 Enrolling by invitation - Heart Failure Clinical Trials

Rivet PVS Therapy in Group 2 PH-HFpEF

Start date: May 10, 2022
Phase: N/A
Study type: Interventional

This clinical investigation is a prospective, multicenter, non-randomized, open-label, Early Feasibility Study to evaluate the safety, performance, and initial clinical efficacy of the Rivet PVS therapy in patients with symptomatic pulmonary hypertension.