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Heart Failure, Systolic clinical trials

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NCT ID: NCT03627585 Not yet recruiting - Clinical trials for Heart Failure, Systolic

Reprogramming to Prevent Progressive Pacemaker-induced Remodelling

PPPR
Start date: August 2018
Phase: N/A
Study type: Interventional

The aim is to provide evidence of the long-term benefits of personalised pacemaker programming on heart function and battery longevity. This will be achieved by showing in a single centre, phase II, double-blind, randomised, placebo-controlled trial that reducing the amount of pacemaker beats to a minimum reverses these changes and extends battery life.

NCT ID: NCT03573869 Recruiting - Atrial Fibrillation Clinical Trials

Atrial FIbrillation Treatment With Cryoballoon in Heart failurE (AFICHE)

AFICHE
Start date: June 1, 2018
Phase: N/A
Study type: Interventional

In this study 404 patients with heart failure and an ejection fraction of 0.40 or less, with paroxysmal atrial fibrillation, will be randomly assigned to standard treatment or standard treatment plus a session of cryoballoon ablation (left atrial balloon cryoablation for pulmonary vein isolation). All patients with either have an ICD or CRT-D/P device implanted or an implantable electrocardiographic monitoring device. The primary study endpoint will be the time to AF burden exceeding 1% over any 30-day period (calculated as the ratio of time spent in AF over total time).16 This AF burden corresponds to 7.2 hours per month. A powered secondary endpoint will be the time to the composite of all-cause mortality and unplanned hospitalization for heart failure.

NCT ID: NCT03553303 Recruiting - Clinical trials for Heart Failure, Systolic

Pharmacodynamic Effects of Sacubitril/Valsartan on Natriuretic Peptides, Angiotensin and Neprilysin

Start date: July 2018
Phase: Phase 4
Study type: Interventional

The study measure multiple neurohormones in patients with heart failure being treated with Sacubitril/Valsartan in increasing doses over an 8 week period.

NCT ID: NCT03537079 Recruiting - Clinical trials for Heart Failure, Systolic

Hypoxic Conditioning in Heart Failure

hypoxheart
Start date: April 20, 2018
Phase: N/A
Study type: Interventional

Heart failure impairs quality of life and exercise capacity, despite an optimal medical therapy. Alternative methods, like hypoxic conditioning coupled to exercise training, must be explored and describe

NCT ID: NCT03534297 Recruiting - Clinical trials for Systolic Heart Failure

Study of Dapansutrile Capsules in Heart Failure

Start date: May 16, 2018
Phase: Phase 1
Study type: Interventional

This is a Phase 1b randomized, double-blinded, single-center safety and pharmacodynamics study of sequential cohort, dose-escalating, repeat-dosing of dapansutrile or placebo (4:1 ratio) in subjects with stable systolic heart failure (HF) with LVEF≤40% symptomatic for NYHA functional classification II-III who show signs of systemic inflammation (high sensitivity plasma C reactive protein [hsCRP] > 2 mg/L). A total of 20 subjects will be enrolled in 2 sequential cohorts by randomized allocation (8 active and 2 placebo within each cohort). Progression of dose escalation will occur following the Day 14 visit of the last subject in the first cohort. Subjects will be screened and evaluated twice for eligibility: 1) at the time of Screening (up to 28 days prior to enrollment); and 2) at the Baseline visit, prior to randomization. Following enrollment, Baseline assessments will be conducted and the first dose of investigational product (either dapansutrile capsules or placebo capsules) will be administered at the clinical site upon completion of all assessment and collection of baseline parameters. Subjects will then self-administer investigational product once or twice daily, depending on cohort, for up to fourteen (14) consecutive days beginning at the Baseline visit and continuing through the planned Day 14 visit. Subjects will return to the study clinic on Days 4, 8, 14 and 28 for follow-up visits. Additionally, subjects will be contacted for telephone follow-up on Day 42. Subjects will be screened and evaluated twice for eligibility: 1) at the time of Screening (up to 28 days prior to enrollment); and 2) at the Baseline visit, prior to randomization. Following enrollment, Baseline assessments will be conducted and the first dose of investigational product (either dapansutrile capsules or placebo capsules) will be administered at the clinical site upon completion of all assessment and collection of baseline parameters. Subjects will then self-administer investigational product once or twice daily, depending on cohort, for up to fourteen (14) consecutive days beginning at the Baseline visit and continuing through the planned Day 14 visit. Subjects will return to the study clinic on Days 4, 8, 14 and 28 for follow-up visits. Additionally, subjects will be contacted for telephone follow-up on Day 42.

NCT ID: NCT03532412 Completed - Periodic Breathing Clinical Trials

Different Loop Gain Phenotypes in Patients With Chronic Systolic Heart Failure and Periodic Breathing

Start date: June 28, 2016
Phase:
Study type: Observational

Central sleep apnoea (CSA) is common in patients with chronic systolic heart failure (HFrEF). Various trials have shown a prevalence of 21 - 37% in this group of people. Up to 66% of patients with CSA and HFrEF present with periodic breathing (PB), which is considered being a marker of HF severity and poor prognosis. Brack et al. summarized data from cohorts, longitudinal studies and retrospective analyses showing an independently increased risk of death in HF patients with PB (HR 2.1-5.7 in five of seven studies). Furthermore, PB in HF patients is known to reduce quality of life and exercise performance and to increase sympathetic nerve activity as well as the probability of malignant cardiac arrhythmias. The pathogenesis of PB is characterized by an instability of ventilatory drive. The level of carbon dioxide (CO2) in blood and cerebrospinal fluid correlates linearly with minute ventilation. A high level of CO2 increases ventilation while hypocapnia dampens it. This control theory is based on the loop gain (LG), which represents the sensitivity and reactivity of the ventilatory system and comprises three components: The plant gain defines the capacity of the system to change PaCO2 in response to a change in ventilation (metabolic response). It is influenced by the lung volume as well as the anatomy of the thorax and the upper airways. The feedback gain is defined by the chemoreceptor responsiveness in reaction to blood gas changes. The controller gain is represented by the respiratory control center in the brain stem and defines the capacity of the system to change ventilation in response to a change in PaCO2 (ventilatory response). Sands et al. proposed and validated a mathematical model based on the ventilatory cycle pattern that quantifies the feedback loop. The ratio of ventilatory and cycle duration within the PB pattern is defined as the duty ratio (DR), which is the basis to calculate the LG. Any temporary breathing disturbance causing a PB pattern with a LG < 1 stabilizes within a few breathing cycles. A LG > 1 represents an unstable ventilatory response and slight changes of CO2 are accompanied by overshooting and undershooting of the ventilation. In that case, the polysomnography shows the typical pattern of waxing and waning of the tidal volume and effort. HF patients typically present with an increased LG due to an impaired left ventricular function and a hyperstimulation of pulmonary vagal receptors. Furthermore, Khoo showed an increased chemosensitivity (controller gain) as well as a decreased ventilatory capacity (plant gain) in this group of people. Sands and colleagues characterized PB considering the mean LG derived from several ventilatory cycles during non-REM sleep. This retrospective study of PB in HFrEF patients addresses the following questions: 1. Is a single LG value appropriate to characterize the individual PB? 2. Does the LG depend on sleep stage and body position? 3. Does the intraindividual LG variability allow for the discrimination of different PB phenotypes and, if so, do these phenotypes differ in further characteristics?

NCT ID: NCT03511248 Recruiting - Heart Failure Clinical Trials

Effect of Dietary Nitrate Ingestion in Heart Failure

DiNOmo-HF
Start date: June 1, 2018
Phase: Phase 2
Study type: Interventional

This study evaluates the addition of inorganic dietary nitrate to the optimal treatment of patients diagnosed with heart failure with reduced ejection fraction. Some vegetables contain large amounts of inorganic nitrate, and research suggests that this nitrate has beneficial effects on the heart and blood vessels. We have shown in lab experiments that nitrate has positive effects on the heart. We wish to test whether dietary nitrate might be useful in halting deterioration and/or improving heart function in patients with heart failure, with a specific focus on a marker of poor outcome in heart failure: high uric acid levels. Half of the patients will receive nitrate-rich beetroot juice, and the other half a nitrate-deplete placebo beetroot juice.

NCT ID: NCT03504891 Recruiting - Clinical trials for Chronic Systolic Heart Failure

Cardiac MRI for Optimal Heart Failure Outcomes With CRT Upgrades

Start date: January 1, 2018
Phase: Phase 1
Study type: Interventional

This study will investigate the use of cardiac MRI in patients with standard ICDs and pacemakers to inform how cardiac resynchronization therapy (CRT) can best be implemented in these patient and which patients are the best candidates for CRT.

NCT ID: NCT03492788 Recruiting - Clinical trials for Heart Failure, Systolic

Optimizing CRT With ECGI

optCRT
Start date: December 28, 2017
Phase: N/A
Study type: Interventional

CRT is delivered from two electrodes on opposite sides of the heart [right (RV) and left ventricle (LV)] delivering stimulation for more efficient heart beats. There is flexibility in the sequence and temporal staggering of the stimulation from these two electrodes with a different optimum for different patients. However, standard techniques to figure out the optimal stimulation strategy like standard 12-lead surface electrical recording (ECG) or routine ultrasound have failed. The investigators have developed ECG imaging (ECGI) with 250 electrode surface recording combined with CT scan to reconstruct high resolution 4-dimensional panoramic electrical maps of the heart. The study seeks to enroll 56 patients undergoing CRT in a clinical trail to evaluate short and long term impact of using ECGI for optimal programming of CRT.

NCT ID: NCT03446313 Recruiting - Clinical trials for Cardiovascular Diseases

Technology-Based Intervention to Promote Heart Health After Cardiac Rehab (Mobile4Heart)

Mobile4Heart
Start date: February 28, 2018
Phase: N/A
Study type: Interventional

The purpose of this study is to determine whether using a mobile app increases adherence to a heart healthy prescription after discharge from a cardiac rehab program.