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Heart Failure, Congestive clinical trials

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NCT ID: NCT02939157 Completed - Clinical trials for Heart Failure, Congestive

Pocket-sized Ultrasound for Point-of-care Diagnosis of Heart Failure

POCUS
Start date: December 12, 2016
Phase:
Study type: Observational

Assessment of pocket sized ultrasound (Vscan GE Healthcare) for diagnosing heart failure in primary care patients, with a comprehensive cardiac ultrasound examination (Siemens Acusan P10) performed at a specialized the eco.lab, as reference.

NCT ID: NCT02925546 Completed - Clinical trials for Heart Failure, Congestive

A Phase I Study to Assess the Pharmacokinetics of GSK2798745 Tablets

Start date: October 2016
Phase: Phase 1
Study type: Interventional

GSK2798745 is being developed as a novel therapeutic intervention for the treatment of pulmonary edema associated with heart failure (HF) and is currently under investigation in the form of a compounded capsule. This is an open-label, randomized, single-dose, crossover study with the purpose to determine the pharmacokinetics (PK) of three 2.4 milligrams (mg) tablet formulations of GSK2798745 in 12 healthy subjects. The three formulations developed for this study will be micronized GSK2798745 active pharmaceutical ingredient (API) (Tablet A), micronized GSK2798745 API with sodium lauryl sulfate (SLS) and hypromellose (Tablet B), milled GSK2798745 API with SLS and hypermellose (Tablet C), and Tablet D, which will be either A/B/C based on interim PK analysis of data from the first three treatment periods. Following a 30-day screening period, subjects will be randomized to one of the 6 treatment sequences: Treatment sequence 1: ABCD, 2=CABD, 3=ACBD, 4=BACD, 5=BCAD, 6=CBAD over three 4-day treatment periods. For treatment period 4, the best formulation based on the interim analysis data from the three treatment periods will be evaluated under fed conditions. Each treatment period will be separated by a minimum of 7 (+14)-day washout period. The total duration of participation in the study will be approximately 11 weeks including the follow-up visit.

NCT ID: NCT02901314 Completed - Clinical trials for Heart Failure, Congestive

My Recordable On-Demand Audio Discharge Instructions

MyROAD
Start date: March 1, 2016
Phase: N/A
Study type: Interventional

Non-adherence to the heart failure (HF) plan of care after hospital discharge has been associated with clinical outcomes, including the combined endpoint of all-cause mortality and rehospitalization for decompensated HF. Patients and informal caregivers receive education materials but may not act due to multiple factors. A recorded message that could be repeatedly played by patients and caregivers might increase adherence to post-discharge self-care behaviors and early follow-up appointments, and have clinical benefits related to a reduction in all-cause mortality and rehospitalization. The purposes of this randomized, controlled study are to examine the effects of use of a novel MyROAD (Recordable On-Demand Audio Discharge) card, given to patients at discharge. The aims of this single-blind, placebo-controlled study are to examine the effects of recorded messages that can be replayed post discharge (delivered via the MyROAD card) on multiple subjective and objective clinical outcomes.

NCT ID: NCT02772068 Completed - Clinical trials for Heart Failure, Congestive

Hemodynamic Response to Exercise in HFpEF Patients After Upregulation of SERCA2a

Start date: September 15, 2015
Phase: Early Phase 1
Study type: Interventional

Heart failure with preserved ejection fraction or HFpEF, represents nearly 50% of all heart failure cases and is particularly common in the elderly. The disease has no current treatment options. Symptoms typically occur during exertion or exercise and is likely the result of increased cardiac and pulmonary congestion as a result of impaired diastolic function. Istaroxime is a novel activator of SERCA2a, an important regulator of calcium uptake within the myocyte. We will test the hypothesis that Istaroxime will improve diastolic function during exercise in HFpEF patients which in turn will reduce cardiac and pulmonary congestion.

NCT ID: NCT02729922 Enrolling by invitation - Clinical trials for Heart Failure, Congestive

Registry of Patients With CardioMEMS

Start date: March 2016
Phase:
Study type: Observational [Patient Registry]

CardioMEMS is an implantable wireless hemodynamic monitoring system which can transmit the pulmonary artery pressure. This device is FDA approved to be used as a diagnostic tool to help management of selected heart failure patients. Heart failure patients with NYHA class III heart failure, irrespective of the left ventricular ejection fraction, and a previous hospital admission for heart failure in the past 12 months, without stage IV or V chronic kidney disease are candidates to receive a CardioMEMS device. Our goal is to create a registry of all patients that receive a CardioMEMS device and monitor outcomes, primarily heart failure hospitalizations, heart failure related quality of life and re-admissions.

NCT ID: NCT02672618 Recruiting - Clinical trials for Heart Failure,Congestive

Clinical Research to Explore Manifestations of Heart Failure Using Infrared Thermal Imaging Technology

Start date: November 2015
Phase: N/A
Study type: Observational

The purpose of this study is to explore manifestations of Heart Failure Using Infrared Thermal Imaging Technology.

NCT ID: NCT02660385 Completed - Pain Clinical Trials

Insomnia Self-Management in Heart Failure

HSS
Start date: March 7, 2016
Phase: N/A
Study type: Interventional

Chronic insomnia may contribute to the development and exacerbation of heart failure (HF), incident mortality and contributes to common and disabling symptoms (fatigue, dyspnea, anxiety, depression, excessive daytime sleepiness, and pain) and decrements in objective and subjective functional performance. The purposes of the study are to evaluate the sustained effects of CBT-I on insomnia severity, sleep characteristics, daytime symptoms, and functional performance over twelve months among patients who have stable chronic HF and chronic insomnia. The effects of the treatment on outcomes of HF (hospitalization, death) and costs of the treatment will also be examined. A total of 200 participants will be randomized to 4 bi-weekly group sessions of cognitive behavioral therapy for CBT-I (behavioral was to improve insomnia and sleep) or HF self-management education. Participants will complete wrist actigraph (wrist-watch like accelerometer) measures of sleep, diaries, reaction time, and 6 minute walk test distance. They will also complete self-report measures of insomnia, sleep, symptoms, and functional performance. In addition the effects on symptoms and function over a period of one year.

NCT ID: NCT02324400 Not yet recruiting - Renal Insufficiency Clinical Trials

Pilot Study for the Evaluation of the Safety and Performance of the RenaSense System in Hospitalized Acute Decompensated Heart Failure Patients

Start date: January 2015
Phase: Phase 1/Phase 2
Study type: Interventional

The study is intended to verify the safety and assess the performance of up to 3-days treatment protocol with the RenaSense System in ADHF patients.

NCT ID: NCT02135861 Completed - Clinical trials for Heart Failure, Congestive

A Method Validation Study for Evaluation of Novel Treatments Limiting Pulmonary Oedema in Cardiac Failure

Start date: July 30, 2014
Phase: Phase 1
Study type: Interventional

Transient receptor potential vanilloid 4 (TRPV4) channel blockade may be promising in the treatment of pulmonary oedema and dyspnoea in heart failure (HF) and acute decompensated heart failure (ADHF) patients by re-establishing the alveolar septal barrier. Dynamic contrast enhanced (DCE) Magnetic Resonance Imaging (MRI) is an established technique for assessing changes in vascular permeability and interstitial water volume. The aim of this study is to establish the potential utility of DCE-MRI as a novel endpoint for dose ranging and proof of mechanism studies of TRPV4 blockers. The DCE-MRI markers of vascular permeability and pulmonary oedema will be measured in subjects with HF (group 2) and healthy volunteers (HV) (group 1) at rest to determine if there is a difference between the two populations. Apart from this, exercise induced changes relative to rest in interstitial volume and exchange rate will be evaluated in both HV and subjects with HF. Additionally, the capability of DCE-MRI to detect changes in interstitial lung fluid in patients with acute decompensated heart failure (ADHF) (group 3) will be investigated. DCE-MRI markers of pulmonary oedema will be assessed when patients are initially hospitalized with ADHF and subsequently after receiving standard of care treatment to determine whether differences can be detected by this methodology.This study will enrol a sufficient number of subjects to have at least 24 subjects in Group 1 and 2 (group 1:12 HV and group 2: 12 subjects with HF) and atleast 5 subjects in Group 3. For each subject, the MRI data must be of sufficient quality to enable DCE-MRI modelling from 2 Sessions. For group 1 and 2, the subjects will have screening visit and 3 MRI sessions. For the first scanning session, subjects will undergo the baseline procedure. The second imaging session will occur approximately one week later to measure within subject variability. A third imaging session (which will be conducted in 2 visits) will incorporate a bicycle exercise challenge prior to the MRI scan, and this third scan will be performed approximately one to three days after the second imaging session. For group 3: Screening will occur during hospitalization for eligibility. Session 1of MRI will be conducted while the subject is still hospitalized. Session 2 will be conducted within 4 weeks of the first scan, when the signs of pulmonary oedema are considered to be resolved. If a subject's pulmonary oedema has not resolved at Session 2, then the subject will be not be scanned by MRI at Session 2 and will be brought back for Session 3 up to 4 weeks after Session 2 for their second MRI.

NCT ID: NCT01966887 Terminated - Clinical trials for Ischemic Cardiomyopathy

AAV1-CMV-Serca2a GENe Therapy Trial in Heart Failure

AGENT-HF
Start date: December 2013
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine the effect of intracoronary SERCA2a Gene transfer on cardiac volumes and function using multimodality cardiac imaging.