Heart Failure Clinic in Springfield, OH - Site Visit for LifeVest Study
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You are the SC/ CRC for a Heart Failure clinic located in
Springfield, OH
•
Your site has been approached by Zoll Medical the
makers of LifeVest to conduct an SQV.
•
Your site visit is scheduled for Wed, 23 Sep 2020 at 6 PM
•
You are required to provide site capabilities information
to support a study for acute decompensated Heart
failure
•
All site files and study synopsis is provided in a separate
cover.
•
You will provide site population data and discuss site
questionnaire information to support your site
capabilities.
Site Staff
•
PI- Dr. Pradeep Gujja
•
Sub-I – Dr. Mohammed Aktar
•
Sub-I – Dr. Mohammad S. Ashraf
•
Sub-I – Avindar Gupta
•
Sub-I – Dr. Lolita Randawar
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Mercy Health- Springfield Heart 100 W.
McCreight Ave. 2
nd
Floor. Springfield, OH
•
www.mercy.com
PSSV Discussion with PI
•
Site Heart failure population
•
Recruitment efforts during COVID-19
•
Structure of Heart Failure Clinic
•
How does PI delegate clinical staff to a study
•
How many MD support the PI
•
How will PI identify Patients
•
What is the hospital policy to use arrythmia
data provided by Zoll in the management of
HF patients, are there hospital restrictions to
download clinical reports
•
Will the PI allocate time to review the
weekly report and delegate SC to call the
patient?
•
How does the PI manage AEs
PSSV Discussion with PI
•
Site Heart failure population
•
Recruitment efforts during COVID-19
•
Structure of Heart Failure Clinic
•
How does PI delegate clinical staff to a study
•
How many MD support the PI
•
How will PI identify Patients
•
What is the hospital policy to use arrythmia
data provided by Zoll in the management of
HF patients, are there hospital restrictions to
download clinical reports
•
Will the PI allocate time to review the
weekly report and delegate SC to call the
patient?
•
How does the PI manage AEs
Acute Decompensated Heart Failure
•
HF (systolic or diastolic) can result from any
structural or functional impairment of
ventricular filling or ejection of blood
•
LVEF
•
HFrEF - Clin Dx of HF < 40%
•
HFpEF – Clin Dx of > 40-50% with abnormal LV
diastolic function
•
Pulmonary congestion is an acute increase in
extravascular lung water EVLW and a common
manifestation of ADHF.
•
The worsening of HF symptoms with fluid build
up in the lungs can lead to symptoms listed
•
Population in the US is > 5 million with over
650,000 Dx annually.
•
50% of patients die within 5 years of Dx.
•
Cost is >$30B annually
•
Dyspnea- difficulty breathing
•
Swollen legs and feet
•
Fatigue
•
Acute respiratory distress
•
Hospitalization
•
If patient is not properly monitored, 50% of
patients die within 6 months of Dx.
Left
Right
LV heart failure
(reduced systolic
EF) causes fluid
to back-up.
Blood cannot
flow to the brain
causing
confusion.
RV heart failure causes
fluid back-up in the RV
when the pump breaks,
causing venous
distention, confusion in
the brain. Fluid back-up
in the periphery,
causing jugular venous
distention, peripheral
edema
,
Brain – altered
mental status
due to low
flow state of
blood flow
Kidney
Reduced LVHF will also
produce a S3 heart sound
on examination using a
stethoscope. Reduced
blood flow to the kidney
causes renal failure
Fluid will back-up
to the lungs
causing dyspnea on
exertion, shortness
of breath,
orthopnea
Fluid build up
occurs in the lower
limbs because
peripheral edema
of and bowel fills
with fluid causing
malabsorption-
belly ache
Management of ADHF
•
Volume Overload
•
Flash Pulmonary edema from uncontrolled
hypertension
•
Atrial Fibrillation
•
Hypotension
•
Reduced organ perfusion from reduced cardiac
output leading to shock from low oxygen
•
For most of these patients lifestyle
modifications such as diet and weight loss has
not been successful due to sedentary lifestyles
•
Poor management of dietary discretion
•
Possible medication non-compliance.
•
The heart muscles (wall of the ventricles)
become very weak from working overtime to
pump enough blood and supply the entire
body with oxygen
How to Diagnose ADHF
Pathophysiology
•
Chest- x-ray – will show cardiomegaly –
enlargement of the heart
•
Pulmonary edema- left heart is backing up
fluid into the pulmonary circulation.
•
BNP value – Brain Natriuretic Peptide: a
blood test that shows the ventricles releases
proteins into the bloodstream due to the
stress of the overworked muscles. It is
higher if you have CHF.
•
Echocardiography- gold standard- will show
Systolic HF- dialated; Diastolic HF-
constricted; MI, or other type of pathology
•
Cardiac Catherization – will determine any
other underline pathology
Management of ADHF
•
Therapy goals are to manage the triggers of
this disease and relieve symptoms
•
For most of these patient, lifestyle
modifications such as, diet and weight loss
has not been successful due to sedentary
lifestyles
•
Poor management of dietary discretion.
•
Possible medication non-compliance.
Class of CHF- NYHA functional Class
•
Stage A- high risk with no structural heart
disease
•
Stage B – structural disease but no HF
symptoms
•
Stage C – Structural Heart disease with
prior HF symptoms
•
Stage D - Refractory and require durable
mechanical support
•
Class
•
Class I
•
Class I-III
•
Class IV
Management of CHF
•
Is determine by what class of CHF the patient has and to minimize the risk
factor, regardless of the class, all MD follow ;
•
Diabetes – Put them on insulin
•
HBP – hypertensive meds
•
High cholesterol – put them on statins
•
COPD- put them on a CPAP
•
Reduce Na+ intake and H
2
0 intake; high Na causes the body to retain water.
Management
of CHF
•
Our focus is on NYHF Class IV patients that
require some form of mechanical support
and monitoring post hospitalization.
•
Despite improvement with medical therapy,
the readmissions of these patients pose a
significant burden to the healthcare system.
•
The Zoll MicroCor device monitors ADHF
patients who have been admitted and
require post-hospitalization monitoring.
•
Outpatient monitoring and lung impedance
management can significantly reduce repeat
hospitalization, therefore reducing the
healthcare burden.
Management
of CHF
•
The SC will work with the CRA to provide site
capabilities information to manage this
study.
•
Good luck everyone!
Heart Failure clinic in Springfield, OH has been approached by Zoll Medical to conduct a study on acute decompensated heart failure. The clinic's capabilities, staff, and procedures for patient recruitment during COVID-19 are discussed. The study focuses on patients with systolic or diastolic heart failure and addresses the management of acute decompensated heart failure symptoms such as pulmonary congestion.
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Presentation Transcript
You are the SC/ CRC for a Heart Failure clinic located in Springfield, OH Your site has been approached by Zoll Medical the makers of LifeVest to conduct an SQV. Your site visit is scheduled for Wed, 23 Sep 2020 at 6 PM You are required to provide site capabilities information to support a study for acute decompensated Heart failure All site files and study synopsis is provided in a separate cover. You will provide site population data and discuss site questionnaire information to support your site capabilities. Clinic Site Clinic Site Preparation Preparation for a PSSV for a PSSV
PI- Dr. Pradeep Gujja Sub-I Dr. Mohammed Aktar Sub-I Dr. Mohammad S. Ashraf Sub-I Avindar Gupta Sub-I Dr. Lolita Randawar Site Staff
Mercy Health- Springfield Heart 100 W. McCreight Ave. 2ndFloor. Springfield, OH www.mercy.com Site Location Site Location
Site Heart failure population Recruitment efforts during COVID-19 Structure of Heart Failure Clinic How does PI delegate clinical staff to a study How many MD support the PI How will PI identify Patients PSSV Discussion with PI What is the hospital policy to use arrythmia data provided by Zoll in the management of HF patients, are there hospital restrictions to download clinical reports Will the PI allocate time to review the weekly report and delegate SC to call the patient? How does the PI manage AEs
Site Heart failure population Recruitment efforts during COVID-19 Structure of Heart Failure Clinic How does PI delegate clinical staff to a study How many MD support the PI How will PI identify Patients PSSV Discussion with PI What is the hospital policy to use arrythmia data provided by Zoll in the management of HF patients, are there hospital restrictions to download clinical reports Will the PI allocate time to review the weekly report and delegate SC to call the patient? How does the PI manage AEs
Acute Decompensated Heart Failure HF (systolic or diastolic) can result from any structural or functional impairment of ventricular filling or ejection of blood LVEF HFrEF - Clin Dx of HF < 40% HFpEF Clin Dx of > 40-50% with abnormal LV diastolic function Pulmonary congestion is an acute increase in extravascular lung water EVLW and a common manifestation of ADHF. The worsening of HF symptoms with fluid build up in the lungs can lead to symptoms listed Population in the US is > 5 million with over 650,000 Dx annually. 50% of patients die within 5 years of Dx. Cost is >$30B annually Dyspnea- difficulty breathing Swollen legs and feet Fatigue Acute respiratory distress Hospitalization If patient is not properly monitored, 50% of patients die within 6 months of Dx.
RV heart failure causes fluid back-up in the RV when the pump breaks, causing venous distention, confusion in the brain. Fluid back-up in the periphery, causing jugular venous distention, peripheral edema, LV heart failure (reduced systolic EF) causes fluid to back-up. Blood cannot flow to the brain causing confusion. Brain altered mental status due to low flow state of blood flow Fluid will back-up to the lungs causing dyspnea on exertion, shortness of breath, orthopnea Left Right Reduced LVHF will also produce a S3 heart sound on examination using a stethoscope. Reduced blood flow to the kidney causes renal failure Fluid build up occurs in the lower limbs because peripheral edema of and bowel fills with fluid causing malabsorption- belly ache Kidney
Volume Overload Flash Pulmonary edema from uncontrolled hypertension Atrial Fibrillation Hypotension Reduced organ perfusion from reduced cardiac output leading to shock from low oxygen Management of ADHF For most of these patients lifestyle modifications such as diet and weight loss has not been successful due to sedentary lifestyles Poor management of dietary discretion Possible medication non-compliance. The heart muscles (wall of the ventricles) become very weak from working overtime to pump enough blood and supply the entire body with oxygen
Chest- x-ray will show cardiomegaly enlargement of the heart Pulmonary edema- left heart is backing up fluid into the pulmonary circulation. BNP value Brain Natriuretic Peptide: a blood test that shows the ventricles releases proteins into the bloodstream due to the stress of the overworked muscles. It is higher if you have CHF. How to Diagnose ADHF Pathophysiology Echocardiography- gold standard- will show Systolic HF- dialated; Diastolic HF- constricted; MI, or other type of pathology Cardiac Catherization will determine any other underline pathology
Therapy goals are to manage the triggers of this disease and relieve symptoms Management of ADHF For most of these patient, lifestyle modifications such as, diet and weight loss has not been successful due to sedentary lifestyles Poor management of dietary discretion. Possible medication non-compliance.
Class of CHF- NYHA functional Class Stage A- high risk with no structural heart disease Class Stage B structural disease but no HF symptoms Class I Class I-III Stage C Structural Heart disease with prior HF symptoms Class IV Stage D - Refractory and require durable mechanical support
Management of CHF Is determine by what class of CHF the patient has and to minimize the risk factor, regardless of the class, all MD follow ; Diabetes Put them on insulin HBP hypertensive meds High cholesterol put them on statins COPD- put them on a CPAP Reduce Na+ intake and H20 intake; high Na causes the body to retain water.
Our focus is on NYHF Class IV patients that require some form of mechanical support and monitoring post hospitalization. Despite improvement with medical therapy, the readmissions of these patients pose a significant burden to the healthcare system. The Zoll MicroCor device monitors ADHF patients who have been admitted and require post-hospitalization monitoring. Outpatient monitoring and lung impedance management can significantly reduce repeat hospitalization, therefore reducing the healthcare burden. Management of CHF
The SC will work with the CRA to provide site capabilities information to manage this study. Management of CHF Good luck everyone!
