Valley Heart & Vascular Institute - Clinical Trials
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Congestive Heart Failure Trials

ICON ADHF INTERVIEW

“Conceptual Framework and PRO Strategy for Acute Decompensated Heart Failure: Concept Elicitation Study”

Study Objective: The objective of this interview study is to develop a conceptual framework to support adequate measurement of important patient focused aspects of heart failure following hospitalization for ADHF and Identify, modify or develop a Patient-Reported Outcomes (PRO) measure suitable to assess core symptoms and impacts associated with HF in the period prior to and following discharge from an acute decompensated heart failure (ADHF) hospitalization as well as during stable periods of heart failure.

Eligibility: Participants who have a diagnosis of chronic heart failure as defined by at least two healthcare provider visits for heart failure in the past two years (these visits could have been outpatient visits or inpatient visits/hospitalizations, or a combination of the two), AND Hospitalization discharge for ADHF within 45 days of screening, OR No ADHF-related hospitalization in the past 6 months, and no unplanned medical encounter due to heart failure in the past 3 months, left ventricular ejection fraction (LVEF) 20% or higher, New York Heart Association (NYHA) functional class I (up to 20% of the stable patients enrolled), II, III, or IV., community dwelling (.e.g, not residing in an institutional setting such as a nursing home or assisted living, etc, and wiillingness to participate in an audio-recorded interview which will last approximately 60 minutes.

Principal Investigator: Kariann Abbate, MD


PROVE-HF

“A 52 week, open label evaluation of the effects of sacubitril/valsartan (LCZ696) therapy on biomarkers, myocardial remodeling and patient-reported outcomes in heart failure with reduced left ventricular ejection fraction.”

Study Objective: To assess if sacubitril/valsartan will help determine early and more chronic changes in blood (biomarkers) related to the mechanism of action and the effects of treatment over a period of 12 months.

Eligibility: Identified by primary care physician or cardiologist as a candidate for treatment with sacubitril/valsartan as per USPI. (HFrEF≤ 40%)

Principal Investigator:Kariann Abbate, MD


CONNECT-HF

“Care optimization through patient and hospital engagement clinical trial for heart failure.”

Study Objective: Review the outcome of two Heart Failure quality improvement programs for patients with Heart Failure 1 year after discharge.

Eligibility: Reduced EF (left ventricular EF ≤ 40%), admitted to the hospital with acute HF as the primary cause of hospitalization.

Principal Investigator:Kariann Abbate, MD


CHAMP

“Observational registry of treatment patterns in U.S. heart failure patients with reduced ejection fraction.”

Study Objective: Understand real-world treatment patterns, as well as the reasons and barriers for treatment changes, in heart failure patients with reduced ejection fraction.

Eligibility: Chronic heart failure patients with reduced ejection fraction currently treated with oral pharmacotherapy as part of their ‘real world’ heart failure management.

Principal Investigator:Kariann Abbate, MD


AWAKE-HF

“Multicenter, randomized, double-blind, double dummy, parallel group, active-controlled 8-week study and 8-week open label extension to evaluate the effect of initiation of sacubitril/valsartan on objective measures of waking activity and sleep, as health-related quality of life functions in subjects with heart failure and reduced ejection fraction.”

Study Objective: To assess if starting sacubitril/valsartan, when compared to enalapril, will have an effect on both waking activity and sleep in subjects with heart failure and reduced ejection fraction.

Eligibility: Subjects diagnosed with NYHA class II or III heart failure and with reduced ejection (HFrEF).

Principal Investigator:Kariann Abbate, MD


 
 
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