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Heart Failure clinical trials

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NCT ID: NCT02827799 Completed - Heart Failure Clinical Trials

Cognitive Behavioral Therapy for Insomnia in Stable Heart Failure

CBTI-HF
Start date: August 2009
Phase: N/A
Study type: Interventional

The purpose of this exploratory developmental study is to test the feasibility, acceptability, and preliminary efficacy of cognitive behavioral therapy for insomnia (CBT-I) among adults who have stable Heart Failure. Participants were randomized either to a treatment (CBT-I) or attention-control condition (heart failure self management education).

NCT ID: NCT02827500 Completed - Heart Failure Clinical Trials

Predischarge Initiation of Ivabradine in the Management of Heart Failure (PRIME-HF)

PRIME-HF
Start date: July 2016
Phase: Phase 4
Study type: Interventional

The PRIME-HF study is a multi-center, patient-level, randomized, open-label study of approximately 450 patients with reduced (left ventricular ejection fraction) LVEF of ≤ 35% and heart-rate ≥70 beats per minute (bpm) who are being discharged from the hospital following stabilization from acute heart failure (HF)(primary or secondary) and will be randomized to a treatment strategy of predischarge initiation of ivabradine or usual care. All participants should have a follow-up visit within 7-14 days of hospital discharge. Heart rate and systolic blood pressure will be assessed at this clinical visit. For participants randomized to predischarge initiation of ivabradine and on ivabradine 5mg BID, the heart rate may be used to adjust the dose the dose to 2.5mg BID or 7.5mg BID. For participants randomized to usual care, ivabradine may be initiated at the provider's discretion. All participants will have a second follow-up study visit 6 weeks (42 +/- 14 days) post-discharge. Heart rate, systolic blood pressure and quality of life (KCCQ and PGA) will be assessed. For participants already taking ivabradine in either treatment group, the heart rate may again be used to adjust the dose of ivabradine. For participants not yet receiving ivabradine, it may be initiated at the provider's discretion. All participants will receive a 90 (+/-7) day post-discharge phone call by site to assess for event status and tolerability of ivabradine. All participants will have a final study visit at 180 (+/-14) days post-discharge. Heart rate, systolic blood pressure and quality of life (Kansas City Cardiomyopathy Questionnaire and Patient Global Assessment) will be assessed. The attending physician may initiate ivabradine per usual care clinical practice. The primary hypothesis of the PRIME-HF study is that, compared with usual care, a treatment strategy of initiation of ivabradine prior to discharge for a hospitalization with acute HF will be associated with a greater proportion of participants using ivabradine at 180 days. Secondary objectives are to assess the impact of predischarge initiation of ivabradine on:Heart Rate (Change in heart rate from baseline to 180 days and Median heart rate at 180 days) and Patient-Centered Outcomes (Kansas City Cardiomyopathy Questionnaire (KCCQ) and Patient Global Assessment (PGA)). Tertiary objectives will be to explore the impact of predischarge initiation of ivabradine on other assessments of evidence-based implementation of ivabradine and beta-blockers at 180 days. Evaluations will incorporate data based on whether or not indication status was retained and whether or not an ivabradine prescription was provided. Tolerability of ivabradine and adverse events during study follow-up.

NCT ID: NCT02827448 Completed - Heart Failure Clinical Trials

Effectiveness of NephroCheckTM Test to Predict Acute Kidney Injury Following Advanced Cardiac Replacement Therapies

Start date: November 2015
Phase:
Study type: Observational

The purpose of this study is to test how well the NephroCheckTM Test, a noninvasive laboratory test performed on urine, predicts loss of kidney function in patients that have had a heart transplant or a Left Ventricular Assist Device (LVAD) or Total Artificial Heart (TAH) implanted.

NCT ID: NCT02825966 Completed - Heart Failure Clinical Trials

Heart Sounds Measurement Using the Wearable Cardioverter Defibrillator (HS-WCD) Study

Start date: February 2016
Phase: N/A
Study type: Interventional

A prospective, validation study to evaluate the data accuracy of heart sounds recorded by the LifeVest® Wearable Cardioverter Defibrillator (WCD). These data will be compared with the heart sounds data recorded by an FDA-cleared device AUDICOR AM device.

NCT ID: NCT02823795 Completed - Heart Failure Clinical Trials

The Supporting Patient Activation in Transition to Home Intervention

[sPATH]
Start date: September 2016
Phase: N/A
Study type: Interventional

This study evaluates if motivational interviewing sessions aiming to motivate recently discharged patients with either chronic obstructive pulmonary disease or congestive heart failure to be active in post-discharge self-management can reduce re-hospitalization rates.

NCT ID: NCT02823626 Completed - Clinical trials for Acute Decompensated Heart Failure

High-dose Aldosterone Antagonist for Acute Decompensated Heart Failure

Start date: September 2016
Phase:
Study type: Observational

Primary Aims 1. Evaluate the safety of high-dose spironolactone in combination of patiromer in acute decompensated heart failure patients. 2. Evaluate the efficacy of high-dose spironolactone in combination of patiromer in causing volume loss and symptom relief in patients with ADHF treated with high-dose spironolactone. Secondary Aims 1: Evaluate the effect of high-dose spironolactone on urinary sodium excretion and renal function.

NCT ID: NCT02821065 Completed - Heart Failure Clinical Trials

Telehealth for Emergency-Community Continuity of Care Connectivity Via Home-Telemonitoring

TEC4Home
Start date: October 31, 2016
Phase: N/A
Study type: Interventional

Modern technology like computers, smartphones and the Internet enable patients to measure certain health indicators, like blood pressure and body weight, from the comfort of their own homes. This information can also be shared electronically with doctors and other healthcare providers to monitor remotely. This is called home health monitoring. In TEC4Home, we are developing a home monitoring solution for patients with heart failure to support their care and recovery at home after a visit to the emergency department. We hope to show that this solution decreases revisits to the emergency department and increases quality of life for patients.

NCT ID: NCT02819973 Completed - Heart Failure Clinical Trials

Educational Videos to Address Racial Disparities in Implantable Cardioverter Defibrillator Therapy

VIVID
Start date: July 2016
Phase: N/A
Study type: Interventional

VIVID is a prospective, multicenter, randomized clinical trial in African American patients that will to evaluate: (1) the effect of an educational video on knowledge of sudden cardiac death (SCD) and implantable cardioverter defibrillators (ICDs); (2) the effect of an educational video on the decision for ICD implantation, decisional conflict, and receipt of an ICD within 90 days; and 3) the effect of racial concordance between study patients and video participants (health care providers/patients) on the decision for ICD implantation, decisional conflict and ICD receipt within 90 days.

NCT ID: NCT02819271 Completed - Heart Failure Clinical Trials

A First-in-Human Study of the Safety of Single Continuous Intravenous (IV) Infusions of CXL-1427 for up to 48 Hours in Healthy Volunteers

Start date: February 2014
Phase: Phase 1
Study type: Interventional

This study is designed to assess a safe dosage of the drug CXL-1427 (BMS-986231) in healthy volunteers.

NCT ID: NCT02816736 Completed - Heart Failure Clinical Trials

EntrestoTM (LCZ696) In Advanced Heart Failure (LIFE Study)

HFN-LIFE
Start date: March 2, 2017
Phase: Phase 4
Study type: Interventional

The primary objective of the study is to determine whether, in patients with symptomatic, advanced heart failure due to left ventricular systolic dysfunction, treatment with LCZ696 for 24 weeks will improve Pro-B-type Natriuretic Peptide (NT-proBNP) levels, which reflect hemodynamic and clinical status, compared to treatment with valsartan.