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52 active trials for Heart Failure With Preserved Ejection Fraction

Wearable Remote Monitoring of Heart Rate and Respiratory Rate for Heart Failure

The primary objective of this study is to study in heart failure (HF) patients to better assess HF disease state, which can aid in management and improve outcomes. Primary aims of the study include: (1) Measure HR and RR at rest and during daily activity using the WHOOP device. (2) Correlate HR and RR response to activity to New York Heart Association (NYHA) class and 90-day HF hospitalization rate. (3) Identify additional predictors of NYHA class and HF hospitalization rate for algorithm development to use the WHOOP device as a clinical tool for HF management.

Start: March 2021

Ketogenic Diet in Patients With Heart Failure

This study is being done to evaluate the effects of a low carbohydrate ketogenic diet on exercise tolerance in patients with Heart Failure with Preserved Ejection Fraction (HFpEF), also known as Diastolic Heart Failure (DHF).

Start: December 2019

Effects of SGLT2 Inhibition on the Mechanisms of Cardiac Damage in the Diabetic Patient With HFpEF

The main aim of this study is to identify the underlying mechanisms of Sodium-glucose co-transporter-2 (SGLT2) inhibitors which are associated to better outcomes in patients with Diabetes mellitus type 2 and Heart Failure with preserved Ejection Fraction.

Start: January 2021

Effort-Lung Ultra Sound

The E-LUS study is a prospective, non randomised, monocenter case-control study. The main objective is to evaluate the association of exercise lung ultrasound data acquired during a stress test on a bicycle ergometer with the diagnosis of heart failure with preserved ejection fraction (HFpEF).

Start: January 2021

Radiofrequency (RF) Ablation for Atrial Fibrillation (AF) in Patients With Heart Failure With Preserved Ejection Fraction

The purpose of this study is to determine if patients who receive an early radiofrequency ablation will have fewer hospitalizations, unplanned office visits, and emergency room visits than those patients treated with medical therapy alone.

Start: January 2021

Spironolactone In The Treatment of Heart Failure

The purpose of this study is to determine whether the treatment of patients with HFmrEF and HFpEF at high risk of cardiovascular events with the mineralocorticoid receptor antagonist (MRA) spironolactone reduces a composite of recurrent heart failure hospitalizations and cardiovascular mortality.

Start: November 2018

Effects of Sacubitril/Valsartan on Subclinical Heart Failure in HIV (The ENCHANTMENT HIV Study)

Persons with HIV, even those well-treated, are at increased risk for heart disease when compared to the general population. Two hormones called aldosterone and brain natriuretic peptide (BNP), which have been shown to be abnormal in HIV, may be associated with inflammation as well as early changes in structure and function of the heart. This study is being conducted to evaluate whether therapies to block aldosterone and increase BNP levels may reduce the burden and progression of heart failure to improve cardiovascular health.

Start: September 2020

Acute Effects of Exogenous Ketone Ester Administration in Heart Failure

The purpose of this study is to test whether a ketone ester drink will improve exercise in people with heart failure (HF) compared to a placebo. In HF, patients are limited in their ability to do all the things they want to do, and exercise as much as they would like, due to becoming tired and short of breath early. There may be several reasons why these symptoms occur. There is some evidence that in addition to problems with the heart, patients with HF also have problems with their arteries and muscles that affect their ability to exercise. Ketones have been shown to improve exercise capacity in healthy volunteers, which may be related to effects on the heart function or on muscles. An infusion of ketones through an intravenous (IV) line has also been shown to significantly improve heart function, but whether a drink can produce similar improvements in HF patients is not known. This drink has been given status by Food and Drug Administration as "generally regarded as safe". The use of DeltaG in this study is experimental. DeltaG has not been approved by the Food and Drug Administration (FDA) for the use being evaluated in this study.

Start: October 2020

Extended IASD Investigation: REDUCE LAP-HF IV

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).

Start: January 2021

Cardiac Magnetic Resonance Assessment for Heart Failure With Preserved Ejection Fraction

This is a prospective study that aims to define the utility of cardiac magnetic resonance feature tracking (CMR-FT) as a non-invasive quantification tool to assess diastolic functionality in patients with Heart Failure with preserved ejection fraction.

Start: June 2018

The Relationship Between Pericardial Fat Thickness and Arterial Stiffness in HFpEF Patients

Heart failure with preserved ejection fraction (HFpEF) was considered as a heterogeneous disease with multi-organ and multi-system design, which is related to various complications, such as hypertension, obesity and arteriosclerosis. Studies have found that hypertension and obesity are respectively associated with increased arterial stiffness. However, there is still no research investigating the the relationship between blood pressure and arterial stiffness in HFpEF patients with different levels of obesity.

Start: September 2020

Endovascular Ablation of the Right Greater Splanchnic Nerve in Subjects Having HFpEF

The objective of this clinical evaluation is to assess the safety and initial effectiveness of catheter-based unilateral ablation of the right greater splanchnic nerve (GSN) in subjects having heart failure with preserved ejection fraction (HFpEF).

Start: January 2021

Assessment of Pulmonary Congestion During Cardiac Hemodynamic Stress Testing

The aim of this study is to utilize lung ultrasound to detect the development of extravascular lung water in patients undergoing clinically indicated invasive hemodynamic exercise stress testing for symptomatic shortness of breath. The study will correlate the lung ultrasound findings with cardiac hemodynamics and measurements of extravascular lung water in an effort to better understand the pathophysiology of exertional dyspnea.

Start: November 2019

Cardiac Amyloidosis in HFpEF

Heart failure with preserved ejection fraction (HFpEF) accounts for half of heart failure cases with heterogenous cause and variable presentations. The diagnosis of HFpEF required clinical signs and symptoms of HF, normal left ventricular ejection fraction (LVEF) and evidence of diastolic dysfunction. No treatment has been shown in recent major clinical trials having benefits in these patients. One major reason of the poor response to medical treatment is the heterogeneity of HFpEF, which contains many different underline causes. To identify the underlying causes of HFpEF may improve the diagnosis and treatment in these patients. Age-related amyloid deposition has first been reported in 1876 and the following autopsy studies showed the prevalence of senile cardiac amyloid is up to 25%. Recently, it has been recognized that the deposits in senile cardiac amyloid are derived from wild-type transthyretin (TTR). Transthyretin amyloidosis cardiac amyloidosis (ATTR CA) is caused by myocardial deposition of misfolded transthyretin protein. There are 2 types of ATTR classified by genetic mutation including wild-type ATTR (ATTRwt) and familial cardiac amyloid caused by TTR mutation (ATTRm). Multimodality techniques have been developed to assist in the diagnosis of the diagnosis of TTR. Among them, 99mTc-3,3-diphosphono-1,2-propanodicarboxylic acid (99mTc-DPD) scintigraphy is a non-invasive test and it can diagnose TTR from other cause diverse form of cardiac amyloidosis and cardiomyopathy. In the study of Gonzalez-Lopez et al, in 120 HFpEF patients, 16 (13.3%) had positive 99mTc-DPD scan. Four patients with positive 99mTc-DPD scan received endomyocardial biopsy and confirmed cardiac amyloid deposition. ATTRwt could be an important cause of HFpEF and it was often under diagnosed. A recent study in Spain reported that 13% of patents over age of 60 years with HFpEF and left ventricular wall thickness of 12mm or more had ATTRwt. However, the prevalence of ATTRwt among patients with HFpEF is not well-established in Taiwan and Asia. The aim of this study is to determine the prevalence, clinical characteristics, risk factors and outcomes of ATTRwt related HFpEF patients in Taiwan.

Start: August 2019

The Relationship Between Blood Pressure and Arterial Stiffness in HFpEF Patients With Different Levels of Obesity

Start: September 2020

Invasive Left Heart Catheterization Registry

Retrospectively enrolled suspicious of heart failure with preserved ejection fraction (HFpEF) patients who underwent left heart catheterization with the measurement of left ventricular end-diastolic pressure.

Start: December 2019

Developing Oral LT3 Therapy for Heart Failure - HFpEF

Investigation of the safety, feasibility, and preliminary efficacy of thyroid hormone therapy with Liothyronine (LT3) in individuals with heart failure with preserved ejection fraction (HFpEF) and low triiodothyronine (T3) syndrome by conducting a randomized, double-blind, placebo-controlled cross-over study with a two-week washout period between treatments.

Start: March 2020

Heart Failure in Norway: Clinical Characteristics, Mortality and Health Care Resource Use

The prevalence of Heart failure above 70 years of age is 10% and 5 year mortality rate above 60%, higher than for cancer. The readmission rate first after hospitalisation is 44% despite the availability of life prolonging and life quality enhancing treatment. There is a lack of resources for adequate diagnostic workup necessary for implementing evidence-based treatment. This projects aims at assessing the impact of guidelines based diagnostic workup and guidelines based treatment of heart failure on mortality and readmission rates. As the symptoms defining the degree of heart failure and the discharge medication only is available in the electronic patient files, artificial intelligence is used to retrieve this information to assess if treatment is according to guidelines. The project is using first a rule based text processing approach using IBM Watson, then advancing to a machine learning approach using readmission and mortality as endpoints. The project has access to digitally stored echocardiographic measurements as well as digital ECG's and lab data on 15 000 patients admitted with a diagnosis of Heart failure. If the retrieval of symptoms and function by artificial intelligence is successful, the next step is to assess if those benefitting the most from echocardiography can be identified using information from the ECG's, lab data or symptoms and functional capacity as described in the Electronic Health Records.

Start: January 2020

Heart Failure and Preserved Ejection Fraction: Observation of Its Progression and Prognosis (HOPP-BERN)

Analysis of longitudinal data, cardiovascular magnetic resonance (CMR) imaging and health related data, of patients with heart failure and preserved ejection fraction (HFpEF) over a timeframe of 5 years per patient. In this study routine clinical data are collected along with additional research parameters measured during CMR. CMR will occur throughout a 5-year follow-up.

Start: March 2020

Electronic S3 Prediction of Hospital Readmissions for HF Exacerbation

The study objective is to measure the value of the third heart sound (S3) for the prediction of recurrent heart failure (HF). For the purpose of this study, a heart failure event will be defined as a hospitalization with a primary diagnosis of heart failure. The main hypothesis of the study is that measurement of S3, using a microelectronic machine microphone positioned in a wearable device (Nanowear Wearable Congestive Heart Failure Management System) near the time of discharge from a hospitalization for heart failure, can predict which patients will be at high risk for a heart failure event, thereby identifying a group in whom increased surveillance and monitoring may decrease hospital readmissions for worsening heart failure.

Start: March 2020