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Heart Failure clinical trials

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NCT ID: NCT03374891 Not yet recruiting - Heart Failure Clinical Trials

DECIDE - ICD: A Multicenter Trial of a Shared DECision Support Intervention for Patients Offered Implantable Cardioverter-DEfibrillators

DECIDE-ICD
Start date: May 28, 2018
Phase: N/A
Study type: Interventional

The investigators goal is to assess real-world effectiveness of patient decision aids (PtDA) for high-risk decisions using the implantable cardioverter-defibrillator (ICD) as a model.

NCT ID: NCT03372954 Not yet recruiting - Heart Failure Clinical Trials

Retrograde Application of Bone Marrow Aspirate Concentrate

Retro
Start date: January 2018
Phase: Phase 2
Study type: Interventional

The aim of our prospective randomised study is to assess the efficacy of the retrograde application of non-selected bone marrow autologous cells concentrate (BMAC) in patients with heart failure with reduced ejection fraction of left ventricle (HFREF) of ischemic aetiology. The evaluated preparation is concentrated BMAC, obtained using Harvest SmartPReP2 technology.

NCT ID: NCT03372512 Not yet recruiting - Heart Failure Clinical Trials

Fluid Status and T1-mapping by CMR

BCM-CMR-T1
Start date: December 15, 2017
Phase: N/A
Study type: Observational [Patient Registry]

It is unclear to what extent systemic fluid overload has an impact on T1-mapping results by cardiovascular mangetic resonance imaging. In this study, patients will undergo body composition monitoring assessing systemic fluid overload and T1-mapping using MOLLI by cardiovacular magnetic resonance imaging in order to investigate a possible association with each other.

NCT ID: NCT03370887 Not yet recruiting - Heart Failure Clinical Trials

AZD8601 Study in CABG Patients

Start date: December 20, 2017
Phase: Phase 2
Study type: Interventional

This is a randomized, double-blind, placebo-controlled, sequential design, multicentre study in patients with moderately impaired systolic function undergoing CABG surgery. Twenty four (24) patients scheduled for elective bypass surgery will be randomized (up to approximately 33 patients if replacements are needed). The objective is to investigate safety and tolerability of AZD8601 following epicardial injection in patients undergoing Coronary Artery Bypass Grafting (CABG) surgery with moderately impaired systolic function. At Visit 3 patients will receive either AZD8601 or placebo as epicardial injections and will then be followed up at 14 days (telephone visit) and 1, 3 and 6 months (on-site) post-surgery.

NCT ID: NCT03366545 Not yet recruiting - Heart Failure Clinical Trials

Observation of Clinical Routine Care for Heart Failure Patients Implanted With BIOTRONIK CRT Devices

BIO|STREAM HF
Start date: January 2018
Phase: N/A
Study type: Observational [Patient Registry]

The registry is primarily designed to assess outcome, efficacy and residual safety aspects of CRT based on long-term data from an unselected, real-life clinical set-up. Moreover, the observation of the patient status should help to find possible predictors for HF events and to identify areas of improvement for CRT and for CRT device settings.

NCT ID: NCT03360448 Not yet recruiting - Heart Failure Clinical Trials

AC6 Gene Transfer in Patients With Reduced Left Ventricular Ejection Fraction Heart Failure

FLOURISH
Start date: February 2018
Phase: Phase 3
Study type: Interventional

To determine the safety and efficacy of an intracoronary injection of adenovirus 5 encoding human adenylyl cyclase 6 (RT-100) in patients with heart failure with reduced left ventricular ejection fraction (HFrEF) in a Phase 3 clinical trial.

NCT ID: NCT03359967 Not yet recruiting - Clinical trials for Heart Failure With Reduced Ejection Fraction

Changes in Intrathoracic Impedance During Sacubitril/Valsartan Treatment

CHILISALT
Start date: February 12, 2018
Phase: N/A
Study type: Observational

The CHILISALT Study aimed to explore the effect of angiotensin-neprilysin inhibition on intrathoracic impedance and -derived fluid index in HFrEF patients who had a device for cardiac resynchronization therapy and/or an implantable cardioverter-defibrillator (ICD; Medtronic Inc., Minneapolis, MN) allowing continuous measurement of intrathoracic impedance.

NCT ID: NCT03359161 Not yet recruiting - Heart Failure Clinical Trials

Clinical Utility of Subcutaneous Furosemide in Patients Presenting With Early Signs of Fluid Overload

Start date: January 2018
Phase: Phase 2/Phase 3
Study type: Interventional

This study will evaluate the usefulness of the subcutaneous administration of a new Lasix formulation. 20 patients will be evaluated in the first phase (pilot phase) and depending on the results, an additional 40 patients will be enrolled (Evaluation Phase). Patients with mild to moderate evidence of fluid overload who present to the cardiology service at St Elizabeth's Medical Center, Brighton, Massachusetts (SEMC) will be included in the study. Patients who qualify for thus study will be sent home with the sc2Wear™ Furosemide Infusor therapy for three days. This is a pump that patients place on their abdomen and it then delivers furosemide to the skin. Participants will be visited at home by a visiting nurse who will give them further teaching on the sc2Wear™ Furosemide Infusor. The visiting nurse will also be responsible for obtaining history (symptoms), physical examination (including inspecting the skin for adverse reactions related to the pump), and laboratory draws, supplementation of electrolytes as needed. Patients will be evaluated by the cardiology service of SEMC within 24 hours of the last dose of the sc2Wear™ Furosemide Infusor. If a patient is found to have satisfactorily responded but requires more therapy, an additional 4 days may be prescribed for total of seven consecutive treatments. If additional units are prescribed, patients will be evaluated by the cardiology service of SEMC within 24 hours of the last dose of the sc2Wear™ Furosemide infusion. Also an additionally, up to three-sc2Wear furosemide at home treatments may be used as authorized by the treating physician in case the patient experiences worsening heart failure within 30-days of enrollment (Rescue Treatment). Participants will be seen in clinic for follow up at 30±3 days after the start of the study for a post treatment.

NCT ID: NCT03358303 Not yet recruiting - Heart Failure Clinical Trials

Effects of Telemonitoring on the Outcome of Heart Failure Patients After an Incidence of Acute Decompensation

Medly-AID
Start date: February 2018
Phase: N/A
Study type: Interventional

Heart failure is the most rapidly rising cardiovascular disease and has come to be recognized as a growing epidemic. Digital health interventions are the most recent iteration of an effort to promote individualized outpatient care through positive behaviour change theory. The UHN team has developed a highly automated and user-centered smartphone-based system, Medly, which allows for the telemonitoring of patients diagnosed with heart failure. The purpose of this study will be two-fold: 1) to determine if the introduction of Medly within two weeks of discharge will improve self-care management, quality of life, and clinical status, 2) to assess whether Medly will lead to a potential reduction in 30 day readmission rates amongst HF patients in the Toronto Central Local Health Integration Network (TC LHIN), without increasing the average length of stay or visits to the emergency department. These parameters will be measured as secondary outcomes.

NCT ID: NCT03357731 Not yet recruiting - Heart Failure Clinical Trials

A Study of Continuous Infusions of HNO (Nitroxyl) Donor in Patients With Heart Failure and Impaired Systolic Function

Start date: November 30, 2017
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the effects of BMS-986231 on systolic and diastolic parameters in patients with heart failure and low ejection fraction.