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Heart Failure clinical trials

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NCT ID: NCT06227819 Completed - Heart Failure Clinical Trials

BVA-200 vs BVA-100 Validation Study

Start date: May 23, 2023
Phase:
Study type: Observational

The proposed study is a prospective, observational, investigator and patient blinded study comparing the results of blood volume measurement using the FDA-cleared Daxor BVA-100 device to the Daxor BVA-200 device. Data from this study may be pooled with data from studies with similar design conducted at other sites, for the purposes of an FDA medical device submission.

NCT ID: NCT06222762 Recruiting - Heart Failure Clinical Trials

Effect of Personalized Follow-up in Adapted Physical Activities in Subjects With Chronic Heart Failure.

BougeTonCoeur
Start date: February 13, 2024
Phase: N/A
Study type: Interventional

France has one million people with heart failure (HF). Exercise intolerance, characterised by dyspnoea, is the main clinical symptom in HF patients and a key determinant of reduced quality of life. In addition to drug and surgical treatments, cardiac rehabilitation programmes have shown benefits in heart failure patients. Lasting at least 3 weeks, these programmes improve physical abilities, quality of life and reduce the risk of hospitalisation for heart failure patients. To date, the real challenge is no longer to prove the benefits of cardiac rehabilitation, but to find solutions to maintain its long-term effects. The transition between the end of the supervised programmes in the centre and the return home is a difficult phase for the majority of patients who do not continue regular physical activity and thus quickly lose the benefits of the programme. To help maintain the benefits of cardiac rehabilitation, some centres offer patients programmes to continue physical activity during phase III. Although these options are often beneficial in the first few months after the end of rehabilitation compared to control groups, the long-term results are mixed. These results imply that one of these maintenance options may not be suitable for all patients. It is therefore important to propose a personalised post-rehabilitation follow-up involving the patient in the choice of physical activities to optimise the maintenance of long-term benefits. We hypothesise that patients who receive personalised support from a sport and health professional following rehabilitation maintain long-term benefits compared to a control group who do not receive this support.

NCT ID: NCT06222099 Not yet recruiting - Heart Failure Clinical Trials

The HEARTFELT Study

HEARTFELT
Start date: September 1, 2024
Phase: N/A
Study type: Interventional

This study looks at the effect(s) of using a remote patient monitoring device (Heartfelt device) with health alerts to monitor the formation of peripheral edema in patients with heart failure (HF). The hypothesis is that this passive measurement method will lead to better data availability, which in turn will improve patient care and reduce unscheduled hospitalizations for the management of worsening HF (HFHs). Patients will be recruited through Remote Patient Monitoring Companies (RPMC) based in the US, using crossover stratified randomization between standard care, Heartfelt device usage with health alerts sent to RPMC and Heartfelt device usage with alerts sent to RPMC as well as on-device alerts in the patient's home.

NCT ID: NCT06218199 Recruiting - Clinical trials for Heart Failure, Congestive

Diuretics vs. Afterload Reduction for Treatment of HeartLogic Alerts

DART-HA
Start date: July 8, 2021
Phase: Phase 4
Study type: Interventional

The DART-HA study is a single-center, open label, trial intended to evaluate the clinical efficacy of standard treatment options for congestive heart failure (observation, diuretic or afterload reduction therapy) in patients without new symptoms who have developed abnormalities of the HeartLogic heart failure diagnostic feature.

NCT ID: NCT06217640 Recruiting - Heart Failure Clinical Trials

Multivariate Biomarker Study for Sarcopenia in Heart Failure

Start date: August 1, 2023
Phase:
Study type: Observational

In the United Kingdom, heart failure (HF) affects about 900,000 people with 60,000 new cases annually. Up to 60% of people living with HF also experience sarcopenia, known as loss of muscle mass and strength. Sarcopenia contributes significantly to low physical capacity and exercise intolerance and worsens the prognosis of the disease and quality of life. In comparison to primary sarcopenia (age-related sarcopenia), secondary sarcopenia occurs if other factors, including malignancy or organ failure, are evident in addition to aging. Secondary sarcopenia is highly common in patients with heart failure (Sarc-HF) (prevalence is 35%-69%), and has a significantly negative impact on exercise capacity, weight-adjusted peak maximal oxygen consumption, left ventricular function, and re-hospitalization rates and mortality. In this integrated study of NHS patients with HF, the investigators aim is to identify the underlying mechanisms of muscle weakness in HF utilizing including body composition, circulating metabolites (metabolic profile), and functional tests for (1) early detection of otherwise subclinical HF, (2) diagnostic assessment of clinically manifest HF-sarcopenia, (3) the risk stratification of subjects with a suspected or confirmed diagnosis, and (4) selection of an appropriate therapeutic intervention.

NCT ID: NCT06217302 Not yet recruiting - Heart Failure Clinical Trials

Sotagliflozin to Slow Kidney Function Decline in Persons With Type 1 Diabetes and Diabetic Kidney Disease

SUGARNSALT
Start date: May 2024
Phase: Phase 3
Study type: Interventional

Powerful new drugs that can prevent or delay end stage kidney disease (ESKD) - so called sodium-glucose cotransporter-2 inhibitors (SGLT2i) - are now available for patients with type 2 diabetes. Whether these drugs have similar effects in patients with type 1 diabetes (T1D) remains unknown because of the few studies in this population, due to concerns about the increase in risk of diabetic ketoacidosis (DKA, a serious, potentially fatal acute complication of diabetes due to the accumulation of substances called ketone bodies) observed with SGLT2i therapy in T1D. One of the few T1D studies conducted to date showed that implementing an enhanced DKA prevention plan can reduce the risk of DKA associated with the SGLT2i sotagliflozin (SOTA) to very low levels. In the present study, a similar DKA prevention program will be used to carry-out a 3-year trial to test the kidney benefit of SOTA in 150 persons with T1D and moderate to advanced DKD. After a 2-month period, during which diabetes care will be standardized and education on monitoring and minimizing DKA implemented, eligible study subjects will be randomly assigned (50/50) to take one tablet of SOTA (200 mg) or a similarly looking inactive tablet (placebo) every day for 3 years followed by 2-months without treatment. Neither the participants nor the study staff will know whether a person was assigned to taking SOTA or the inactive tablet. Kidney function at the end of the study will be compared between the two treatment groups to see whether SOTA prevented kidney function loss in those treated with this drug as compared to those who took the inactive tablet. The DKA prevention program will include participant education, close follow-up with study staff, continuous glucose monitoring, and systematic ketone body self-monitoring with a meter provided by the study. If successful, this study will provide efficacy and safety data that could be used to seek FDA approval of SOTA for the prevention of kidney function decline in patients with T1D and DKD.

NCT ID: NCT06217120 Not yet recruiting - Clinical trials for Heart Failure With Preserved Ejection Fraction

Reversing Microvascular Dysfunction in Heart Failure With Preserved Ejection Fraction

COL-Micro-HF
Start date: March 1, 2024
Phase: Phase 2/Phase 3
Study type: Interventional

This study will evaluate the impact of colchicine on the change in coronary flow reserve (CFR), a marker for coronary microvascular dysfunction (CMD), compared to placebo in patients with heart failure and ejection fraction above 40% (including patients with improved EF).

NCT ID: NCT06215911 Recruiting - Heart Failure Clinical Trials

A Study to Assess Safety & Effectiveness of Tovinontrine in Chronic Heart Failure With Reduced Ejection Fraction (Cycle-1-REF)

Cycle-1-REF
Start date: February 13, 2024
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the safety and effectiveness of tovinontrine compared to placebo to lower NT-proBNP in patients with chronic heart failure with reduced ejection fraction.

NCT ID: NCT06215586 Recruiting - Heart Failure Clinical Trials

Safety & Effectiveness of Tovinontrine in Chronic Heart Failure With Preserved Ejection Fraction (Cycle-2-PEF)

Cycle-2-PEF
Start date: February 13, 2024
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the safety and effectiveness of tovinontrine compared to placebo to lower NT-proBNP in patients with chronic heart failure with preserved ejection fraction

NCT ID: NCT06215248 Not yet recruiting - Heart Failure Clinical Trials

Myocardial Dysfunction Evaluation in Lower Extremity Arterial Disease Patients With Deformation Analysis

MEDAL
Start date: January 2024
Phase:
Study type: Observational

Single centre observational study to assess lower extremity arterial disease (LEAD) patients' cardiac dysfunction with strain analyses and to assess connections between cardiac dysfunction, metabolomic changes and target organ damage in LEAD.