View clinical trials related to Heart Failure.
Filter by:This clinical study is designed to show that a multidisciplinary team following a pre-specified standard of care medication decision model based on data from an implanted cardioverter device will increase the rate of change in Guideline Directed Medical Therapy (GDMT) in the intervention group compared to the conventional group in patients with ischemic and non-ischemic cardiomyopathies.
Prospective combined clinical validation of an algorithmic calculated mean systemic filling pressure (Pms-Nav) with the gold standard for Pms (Pms calculated from venous return curves during inspiratory hold procedures with incremental airway pressures; Pms-Insp). Secondary correlation between invasive cardiac output measurement versus 3D TOE and carotid echo doppler measured cardiac output.
This study will be a double-blind multicenter randomized study (1:1) to evaluate the effect of dapagliflozin 10 mg per day or placebo on short-term functional capacity evaluated through changes in peak oxygen consumption.
Chronic heart failure (CHF) is one of the major causes of death in Western societies. Evidence has accumulated that functionally active autoantibodies directed against the beta1 adrenergic receptor (β1 AAb) are of pathophysiological relevance for the development and progression of cardiomyopathy and associated CHF. BC 007 is under development for targeted neutralisation of autoantibodies directed against G protein coupled receptors, including β1 AAb. This is an open label, three-centre, randomised phase 2a study in participants with chronic HFrEF. The study will evaluate whether BC 007 causes a persistent neutralisation of the β1 AAb demonstrated by a negative β1 AAb status up to 12 months. Participants will be randomised in a 2:1 ratio to the treatment arm (BC 007) or the control arm (untreated). Treatment is repeated once up to month 11 if the participant's β1 AAb were not neutralised after 1st dosing on day 1 or reoccur.
The Mid-Q Response study is a prospective, multi-center, randomized controlled, interventional, single-blinded, post-market study. The purpose of the Mid-Q Response study is to test the hypothesis that the AdaptivCRT (aCRT) algorithm is superior to standard CRT therapy regarding patient outcomes in CRT indicated patients with moderate QRS duration, preserved atrioventricular (AV) conduction and left bundle branch block (LBBB). The study will be executed at approximately 60 centers in Asia. The subjects will be randomly assigned in a 1:1 ratio to the aCRT ON (Adaptive Bi-V and LV) group or the aCRT OFF (Nonadaptive CRT) group. The primary objective is to test the hypothesis that aCRT ON increases the proportion of patients that improve on the Clinical Composite Score (CCS) compared to aCRT OFF at 6 months of follow-up.
The purpose of the pivotal study is to collect blood specimens and clinical data from patients suspected of having Heart Failure (HF), which will be tested at a future date on Natriuretic Peptide assay(s) to validate diagnostic cutoffs and assess HF severity.
This is a randomized study evaluating the effect of routinely collecting a standardized questionnaire of heart failure health status during heart failure clinic visits. Participants will be randomized to early or delayed implementation of a validated health-related quality of life survey (the Kansas City Cardiomyopathy Questionnaire). Participants randomized to early implementation will be given this 12-question survey at each heart failure clinic visit at the beginning of the study; their heart failure clinician will have access to survey results but will continue to manage participants based on standard treatment practice. Patients randomized to delayed implementation will start receiving the survey at each clinic visit one year later. By comparing the health status and treatment rates between early and delayed implementation, this study will determine the impact of standardized health status assessment on patient outcomes and clinician decision-making.
Background: Originally thought to be purely due to LV diastolic dysfunction, studies in western countries have suggested that heart failure with preserved ejection fraction (HFpEF) is more complex. In patients with HFpEF, LV systolic function is commonly considered normal as the global ejection fraction (EF) is normal. However, the EF reflects only the global cardiac contractile function and does not take the subclinical systolic function into consideration. Therefore more attention should be paid on this subset of heart failure population in which the frequency and magnitude of concomitant subclinical systolic dysfunction has not been clearly defined. Objective: The principal objective of this study was to assess the global longitudinal systolic function of the LV in patients with HFpEF in a tertiary level hospital with the aim of finding out the frequency and magnitude of impaired subclinical systolic dysfunction by using Global Longitudinal Strain (GLS) derived from 2D speckle tracking echocardiography and to see if there is any correlation of GLS with New York Heart Association (NYHA) functional class and BNP level in these patients. Methods: This was a cross-sectional study conducted from May 2018 to April 2019. A total of 31 patients with HFpEF (Group I) and 31 healthy volunteers of similar age and sex (Group II) were enrolled in the study by consecutive sampling. Detailed history including NYHA functional class, physical examination, relevant investigations including BNP level was done in patients with HFpEF. 2D echocardiography, color Doppler, tissue Doppler and 2D speckle tracking echocardiography was done in both groups. GLS was obtained in a total of 31 patients with HFpEF (Group I), diagnosed according to the 2016 European Society of Cardiology (ESC) guidelines for the diagnosis and treatment of acute and chronic heart failure and compared with GLS of 31 healthy volunteers (Group II), to find out the frequency and magnitude of impaired subclinical systolic function in patients with HFpEF. GLS was also compared with their NYHA functional class and BNP level to find out if any significant relationship is present. Result: All patients with HFpEF had preserved LV ejection fraction (LVEF>50%) and evidence of diastolic dysfunction. HFpEF patients demonstrated significantly lower GLS compared to healthy controls (14.92 ± 3.16 versus 20.60 ± 1.84). The reduction in LV GLS was statistically significant (p <0.001). Majority of patients with HFpEF (74.2%) had reduced GLS, when reduced GLS was defined as > 2SD below the mean value for healthy volunteers, indicating the presence of subclinical systolic dysfunction in majority of these patients. Worse GLS was associated with higher BNP levels in patients with HFpEF when modeled categorically as quartiles (p = 0.044) and also when modeled continuously (Pearson correlation, r = 0.5, p = 0.004), there was negligible correlation between LV GLS and NYHA symptom class when modeled continuously (Spearman's correlation, rs = 0.052, p = 0.789). Conclusion: Strain imaging detects impaired systolic function despite preserved global EF in patients with HFpEF. Subclinical systolic dysfunction was frequent in the majority of HFpEF patients. Lower LV GLS is associated with higher BNP level. LV GLS was not associated with NYHA functional class. Further large scale studies are recommended to confirm the findings of this study.
Heart failure affects over 25 million people worldwide and nearly 7 million adults in the United States alone. Nearly 25% of patients with heart failure have worsened disease burden from dyssynchronous ventricular contraction due to abnormal electrical impulse propagation. These patients may benefit from cardiac resynchronization therapy (CRT) where contraction between the ventricles is coordinated by simultaneous electrical stimulation of the right and left ventricles. In animal models, CRT changes molecular and cellular biology by improving myofilament function, ion channel regulation, beta-receptor signaling, and overall mitochondrial energetics. In randomized clinical outcomes trials, the use of CRT further reduced the incidence of heart failure events and improved overall mortality. However, nearly 75% of patients with heart failure have synchronous ventricular contraction and therefore do not qualify for CRT. CRT profoundly alters underlying molecular and cellular biology as a result of the transition from dyssynchronous to resynchronized contraction, enhancing myocyte function and adrenergic responsiveness. The investigators previously hypothesized CRT-like benefits could be achieved in otherwise synchronous heart failure by purposely inducing dyssynchrony for several hours each day and then reversing this for the remainder of the time. The investigators termed this pacemaker induced transient dyssynchrony, or PITA, and tested its impact in a canine dilated cardiomyopathy model. Following several weeks of rapid atrial pacing to induce heart failure in the animals, the investigators compared implementing 4-weeks of PITA - consisting of dyssynchronous rapid right ventricular pacing for 6 hours each night and atrial pacing for the remaining time - to animals that always received rapid atrial pacing. The fast rate is used to generate a heart failure phenotype. PITA improved chamber dilation, increased beta-adrenergic responsiveness and contractile function, and improved myofiber structure compared to heart failure canine controls. While first tested in an intact conscious translational model, no study has yet investigated PITA in humans. This pilot research protocol tests the feasibility, safety, and tolerability of PITA in humans with dilated cardiomyopathy. The study will leverage pre-existing Medtronic (Mounds View, MN) pacemaker/defibrillators implanted in dilated cardiomyopathy patients based on current clinical guidelines. If successful, this study will allow for a larger, first-in-human study to assess indexes of left ventricular function in dilated cardiomyopathy patients with PITA.
This is a study in adults who are in hospital for acute heart failure. The purpose of this study is to find out whether starting to take a medicine called empagliflozin soon after first being treated in hospital helps people with acute heart failure. Participants are in the study for about 3 months. At the beginning, participants are still in hospital. Later, they visit the hospital about 3 times and get 1 phone call. Participants are put into 2 groups by chance. One group takes 1 empagliflozin tablet a day. The other group takes 1 placebo tablet a day. Placebo tablets look like empagliflozin tablets but do not contain any medicine. Empagliflozin belongs to a class of medicines known as SGLT-2 inhibitors. It is used to treat type 2 diabetes. During the study, the doctors check whether participants have additional heart failure events like needing to go to the hospital again because of heart failure. The participants answer questions about how their heart failure affects their life. We then compare the results between the empagliflozin and placebo groups. The doctors also regularly check the general health of the participants.