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Heart Failure, Congestive clinical trials

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NCT ID: NCT03200860 Not yet recruiting - Clinical trials for Heart Failure,Congestive

Effects of Empagliflozin on Clinical Outcomes in Patients With Acute Decompensated Heart Failure

EMPA-RESPONSE
Start date: December 2017
Phase: Phase 2
Study type: Interventional

Acute decompensated heart failure is the fastest growing disease in the world and the leading cause of hospital admissions worldwide. Short term mortality and rehospitalization are extremely high (20-30% within 3-6 months) and there is no therapy available that improves clinical outcome in these patients. Empagliflozin is a selective inhibitor of sodium glucose co-transporter with diuretic and renal- protective properties. In patients with type 2 diabetes at high risk for cardiovascular events, empagliflozin reduced the risk of hospitalization for heart failure by 35%. Based on the promising pharmacological profile of empagliflozin in relation to the needs for treatment of acute decompensated heart failure, we hypothesize that empagliflozin exerts positive effects in acute decompensated heart failure, with or without diabetes, This is a randomized, placebo-controlled, double-blind, parallel group, multicenter study in subjects admitted for acute decompensated heart failure. Eighty eligible subjects will be randomized in a 1:1 ratio to receive either empagliflozin 10 mg/day or matched placebo.

NCT ID: NCT03187470 Recruiting - Clinical trials for Heart Failure,Congestive

Left Ventricular Dyssynchrony in Multipole Pacing

Start date: March 1, 2017
Phase: N/A
Study type: Interventional

Left ventricular dyssynchrony will be assessed by echocardiography using different programming of an implantable cardioverter defibrillator.

NCT ID: NCT03177447 Completed - Clinical trials for Heart Failure, Congestive

ENABLE: CHF-PC (Comprehensive Heartcare For Patients and Caregivers)

Start date: July 1, 2013
Phase: N/A
Study type: Interventional

Background: Early palliative care (EPC) is recommended but rarely integrated with advanced heart failure (HF) care. This pilot study engaged patients and family caregivers to study the feasibility and site differences in a two-site EPC trial, ENABLE CHF-PC (Educate, Nurture, Advise, Before Life Ends Comprehensive Heartcare for Patients and Caregivers). An EPC feasibility study (4/1/14-8/31/15) was conducted for patients with New York Heart Association (NYHA) Functional Class III/IV HF and their caregivers in academic medical centers in the northeast and southeast U.S. The EPC intervention comprised: 1) an in-person palliative care consultation; and 2) telephonic nurse coach sessions and monthly calls. Patient- and caregiver-reported outcomes were collected for quality of life (QOL), symptom, health, anxiety, and depression outcomes at baseline, 12- and 24-weeks. Linear mixed-models were used to assess baseline to week 24 longitudinal changes. The intervention was tailored to rural, older adults (ageā‰„65) with advanced HF in reducing HF morbidity and improving patient and caregiver QOL and quality of care.

NCT ID: NCT03102827 Recruiting - Clinical trials for Heart Failure,Congestive

High-Flow-Therapy for the Treatment of Cheyne-Stokes-Respiration in Chronic Heart Failure

FLOAT-CS
Start date: February 2, 2017
Phase: Phase 3
Study type: Interventional

To demonstrate the effectiveness and safety of nocturnal ventilation with oxygen (HFT - high-flow-therapy) for the treatment of CSA in patients with HFrEF compared to placebo (patient will breathe ambient air via nasal cannula that is not connected to the high-flow-device).

NCT ID: NCT03078972 Recruiting - Clinical trials for Heart Failure,Congestive

Effect of mechanIcal circulatoRy Support ON Exercise Capacity aMong pAtieNts With Heart Failure

IRONMAN
Start date: April 7, 2017
Phase: N/A
Study type: Observational

This study will evaluate how the cardiovascular system interacts with mechanical hearts to provide blood flow to the body during exercise. Two aims are proposed: 1) to determine the impact of a mechanical heart on exercise pressor reflexes in heart failure patients; and 2) to define the primary determinant(s) of exercise capacity in heart failure patients before and after device implantation.

NCT ID: NCT03034551 Recruiting - Heart Failure Clinical Trials

Mobile App With Patient Financial Incentives for Adherence to Heart Failure Medications & Daily Self-Weighing

Start date: January 30, 2017
Phase: N/A
Study type: Interventional

The goal of this study is to test the efficacy of a financial incentives-based telehealth intervention to reduce 30- and 90-day heart failure (HF) readmissions by tracking and increasing adherence to patient self-care - specifically by incentivizing adherence to prescribed cardiac medication regimen and daily self-weighing. Patients randomized to the treatment arm will be given a cellular-connected scale to use at home, as well as a mobile app on their smartphone that tracks their adherence to daily self-weighing through the scale and cardiac medications via patient photo submission. The health care team will intervene if a sudden increase in weight is detected (2 lbs/day or 5 lbs/week). Financial incentives of $150 are offered for full adherence over 90 days. Each day where the patient does not step on the scale and complete a medication check-in will result in a deduction of $2 per day from the incentive amount to be paid out. The control group will receive the usual discharge instructions as prescribed by their health care team.

NCT ID: NCT02939157 Enrolling by invitation - Clinical trials for Heart Failure, Congestive

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

POCUS
Start date: October 2016
Phase: N/A
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 Recruiting - Clinical trials for Heart Failure, Congestive

My Recordable On-Demand Audio Discharge Instructions

MyROAD
Start date: March 2016
Phase: Phase 3
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 Recruiting - Clinical trials for Heart Failure, Congestive

Hemodynamic Response to Exercise in HFpEF Patients After Upregulation of SERCA2a

Start date: September 2015
Phase: Phase 0
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.