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Heart Failure clinical trials

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NCT ID: NCT05322616 Withdrawn - Clinical trials for Heart Failure With Preserved Ejection Fraction

Single-Ascending Dose Study of JK07 in Subjects With HFpEF

Start date: October 21, 2022
Phase: Phase 1
Study type: Interventional

A phase 1, randomized, double-blind, placebo-controlled single-ascending dose study to assess JK07 in adult subjects with heart failure with preserved ejection fraction.

NCT ID: NCT05312021 Withdrawn - Clinical trials for Heart Failure With Preserved Ejection Fraction

Selective PDE9 Inhibition With IMR-687 in Adults With Heart Failure With Preserved Ejection Fraction

SP9In-HFpEF
Start date: April 2022
Phase: Phase 2
Study type: Interventional

This study is to evaluate whether 16 weeks of treatment with IMR-687 is a safe and effective treatment for patients with Heart Failure with Preserved Ejection Fraction (HFpEF). The primary objective is to evaluate whether IMR-687 reduces NT-proBNP compared to placebo in these patients.

NCT ID: NCT04890548 Withdrawn - Heart Failure Clinical Trials

Study to Evaluate the Effects of AZD3427 in Patients With Heart Failure

Start date: November 23, 2021
Phase: Phase 1
Study type: Interventional

The primary purpose of this mechanistic study is to evaluate the vasodilatory effects of AZD3427 in adult patients with heart failure and will be performed at approximately 2 study sites in the United Kingdom.

NCT ID: NCT04872959 Withdrawn - Clinical trials for Heart Failure, Systolic

TRANSFORM Heart Failure With Reduced Ejection Fraction

TRANSFORMHFrEF
Start date: October 2021
Phase: N/A
Study type: Interventional

The goal of the TRANSFORM-HFrEF trial will be to study the current guideline-directed medical therapy (GDMT) landscape for HFrEF and determine effective methods and models of increasing adherence to GDMT and improving Quality of Life (QOL) in outpatient settings within the context of the 20-minute visit. This will be achieved through a randomized evaluation that shifts standard clinical interview and documentation requirements outside the office visit and building the patient and physician relationship through trust and shared goal setting. Specific Aims: To evaluate the ability of ACC Solution Sets and Patient Resources to improve initiation and titration of GDMT for eligible patients with HFrEF Left Ventricle Ejection Fraction (LVEF) ≤ 40%. To evaluate change in QOL between patients in the intervention arm and the Usual Care arm. Examine the relative change in GDMT among higher risk versus lower-risk patients in the Intervention arm and Usual Care arm. In this randomized registry trial, sites will be invited to participate in a 6-month study aimed at various processes of care in HFrEF. Sites would be informed that they might be asked to participate in an intensive intervention to improve GDMT prescription or in a study of QOL in HFrEF. Once a list of sites interested in participating is created, sites would be randomized into two arms: an intervention group and a usual care group.

NCT ID: NCT04854200 Withdrawn - Clinical trials for Chronic Heart Failure

HVAD(TM) SMART 1.0 Study

Start date: May 1, 2021
Phase:
Study type: Observational

The purpose of HVAD Smart 1.0 study is to collect HVAD device data (i.e., waveform + logfile + pump parameter) in various clinical conditions (e.g., routine follow-up visits, experiencing adverse events) to support development of predictive and actionable algorithms. The collected data will be used to characterize HVAD flow waveform and logfile pattern changes that precede a qualifying adverse event, as well as characterize "normal" HVAD flow waveform and logfile patterns (subjects free from any qualifying adverse event, any hospital readmissions related to a SAE, or any parenteral medical therapy for heart failure management (e.g., inotropes, diuretics, etc.) or ultrafiltration in last 30 days). In addition, the study will collect data to evaluate the utility of CareLink in HVAD patients. The study will not involve any investigational testing and the market-released devices will used as per the approved labelling.

NCT ID: NCT04782245 Withdrawn - Clinical trials for End-stage Heart Failure

Acute Reno-Cardiac Action of Dapagliflozin In Advanced Heart Failure Patients on Heart Transplant Waiting List

ARCADIA-HF
Start date: September 2022
Phase: Phase 2
Study type: Interventional

In the DAPA-HF trial, the use of dapagliflozin, an inhibitor of sodium-glucose cotransporter 2 (SGLT2), reduced significantly the risk of worsening heart failure or death from cardiovascular causes compared to placebo among patients with heart failure (HF) and a reduced ejection fraction. This new drug offers a very potent and interesting therapeutic pathway since it reduces clinical congestion, it preserves glomerular renal function, does not appear to cause symptomatic clinical hypotension and improves symptoms and quality of life compared to placebo. Advanced heart failure patients with reduced ejection fraction represent a small and severe subgroup of heart failure of patients with frequent worsening heart failure events and high rates of death. The effect of dapagliflozin in this subgroup of patients was not assessed in the DAPA-HF study. The therapeutic profile of SGLT2 inhibitors appears to be of high interest, since this group of patients has a poor tolerance to usual heart failure drugs, frequent worsening renal function and congestive symptoms persistence with poor quality of life scores. Soluble urokinase-type plasminogen activator receptor (suPAR) is a signaling glycoprotein considered to be involved in the pathogenesis of kidney disease. It is associated with the risk of acute kidney injury in different clinical and experimental situation. It is also a new validated biomarker predictive of adverse clinical outcome in heart failure patients. This biomarker allows a better risk stratification in heart failure patients after adjustment for Nt-proBNP. As a useful biomarker implicated in both heart failure and acute kidney injury, suPAR seems to be an interesting biomarker to assess cardio-renal benefits of dapagliflozin. The aim of this study is to investigate if a treatment by dapagliflozin reduces significantly suPAR compared to placebo in a population of advanced heart failure patients, candidates to heart transplantation. The effect of dapagliflozin compared to placebo will also be assessed on other secondary heart failure outcomes in this patient population.

NCT ID: NCT04757246 Withdrawn - Heart Failure Clinical Trials

RESPECT Heart Failure- RESpiratory Pattern Evaluation in Clinical Trials for HF

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

The goal is to evaluate the trends in MouthLab parameters (respiration rate, temperature, pulse rate, electrocardiogram rhythm, blood pressure, oxygen saturation heart rate and basic lung function measures) in patients with decompensated heart failure and how these measurements change in response to decongestion. The research will test the ability of the MouthLab device to predict clinical decompensation in patients with known heart failure and to reduce the number of hospital readmissions based on the treatment guided by MouthLab device data.

NCT ID: NCT04753398 Withdrawn - Heart Failure Clinical Trials

One Heart to Care for

1H2C4
Start date: January 2014
Phase: N/A
Study type: Interventional

This is an open randomized clinical trial with two study arms. One group, receiving usual care for heart failure, will be compared to another group, receiving usual care plus active telemonitoring interference. When leaving the hospital, the usual care arm receives a document with a predefined medication scheme and advice for the general practitioner (like it is currently done in usual care). Besides the normal consultations at 2 and 5 weeks, no active interactions take place between the study nurse and the patient. The telemonitoring interference in the other study arm consists of an automatic blood pressure device and medication dispenser that transmit data to a central platform. During the first 12 weeks, the nurse of the call center will give incentive for medication up titration on the basis of the available data. Before up titration can be done, the patient needs to take blood pressure measurements 3 times in the morning and 3 times in the evening and at least 6 measurements a week.

NCT ID: NCT04697485 Withdrawn - Diabetes Mellitus Clinical Trials

Polydiuretic Therapy for Heart Failure With Preserved Ejection Fraction and Diabetes Mellitus

Start date: January 8, 2021
Phase: Phase 4
Study type: Interventional

This is a single-center, non-randomzied pilot study investigating a combination of targeted therapies as possible treatment for heart failure with preserved ejection fraction (HFpEF). The study interviention is a Low-Dose, Triple Polydiuretic Therapy (LDTPT, or polydiuretic) including loop diuretic (bumetanide), mineralocorticoid receptor antagonist (eplerenone), and Sodium-glucose co-transporter 2 inhibitors (SGLT2i) therapy (dapaglifozin).

NCT ID: NCT04632160 Withdrawn - Clinical trials for Heart Failure With Preserved Ejection Fraction

Extended IASD Investigation: REDUCE LAP-HF IV

Start date: December 1, 2021
Phase: N/A
Study type: Interventional

Multicenter, Prospective, Open Label, Single Arm, Clinical Trial. The primary objective of this clinical trial is to further evaluate the safety and clinical efficacy of the IASD System II in symptomatic heart failure patients with an left ventricular ejection fraction (LVEF) ≥ 40%, and elevated left sided filling pressures despite standard Guideline Directed Medical Therapy (GDMT); and to compare the safety and efficacy results to those from the treatment arm of the REDUCE LAP-HF Randomized Trial II (Corvia protocol 1601).