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External Body Pressure in Heart Failure With Preserved Ejection Fraction

Primary Purpose

Heart Failure, Diastolic

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Positive or negative pressure
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Heart Failure, Diastolic

Eligibility Criteria

30 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Heart Failure Study Population Inclusion Criteria (Aim 1 and 2): Age greater than or equal to 30 yrs Established diagnosis of HFpEF with left ventricular ejection fraction greater than or equal to 50% NYHA II-III symptoms Stable HF drug regimen for the preceding 1 month Wedge pressure greater than or equal to 15 mmHg at rest or greater than or equal to 25 mmHg with peak exercise (For Aim 2 only) Scheduled for an elective right heart catheterization at Duke University Hospital. Exclusion Criteria (Aim 1 and 2): HF hospitalization for type I myocardial infarction within 3 months Infiltrative (ie amyloid) or hypertrophic cardiomyopathy Uncontrolled atrial or ventricular arrhythmia Chronic oxygen use History of vasovagal syncope Considered inappropriate to participate by PI or Sub-I Healthy Volunteers (Controls) Inclusion Criteria (Aim 1): Age greater than or equal to 30 yrs Able to speak English Ambulatory [assistive devices ok] Able to provide informed consent Exclusion Criteria (Aim 1): Acute myocardial infarction (3-5 days) Unstable angina Uncontrolled arrhythmia causing symptoms or haemodynamic compromise Syncope Active endocarditis Acute myocarditis or pericarditis Symptomatic severe aortic aneurysm Uncontrolled asthma Arterial desaturation at rest on room air <85% Untreated left main stem coronary stenosis Asymptomatic severe aortic stenosis Severe untreated arterial hypertension at rest (>200 mm Hg systolic, >120 mm Hg diastolic) Tachyarrhythmias or bradyarrhythmias Hypertrophic cardiomyopathy Significant pulmonary hypertension Thrombosis of the lower extremity until treated for a minimum of 2 weeks Within 2 weeks of acute symptomatic pulmonary embolus Abdominal aortic aneurysm >8.0 cm Electrolyte abnormalities Pregnancy Inmate of correctional facility (i.e. prisoner) Diagnosed history of dementia Inability to ambulate independently Considered inappropriate to participate by Principal Investigator

Sites / Locations

  • Duke University Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Experimental

Arm Label

Experimental: Patients with heart failure (Aim 1)

Control: Healthy Volunteers (Aim 1)

Experimental: Patients with heart failure (Aim 2)

Arm Description

Outcomes

Primary Outcome Measures

change in exercise cardiac output
Change in cardiac output from rest to 0 Watts exercise

Secondary Outcome Measures

change in exercise cardiac output
Change in cardiac output from rest to 20 Watts exercise
change in heart rate
Change in heart rate from rest to 0 Watts exercise
change in heart rate
Change in heart rate from rest to 20 Watts exercise
change in respiratory rate
Change in heart rate from rest to 20 Watts exercise
change in O2 consumption
Change in O2 consumption from rest to 0 Watts exercise
change in O2 consumption
Change in O2 consumption from rest to 20 Watts exercise
Change in wedge pressure
Change in wedge pressure from rest to 0 Watts exercise
Change in wedge pressure
Change in wedge pressure from rest to 20 Watts exercise

Full Information

First Posted
February 25, 2023
Last Updated
May 17, 2023
Sponsor
Duke University
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1. Study Identification

Unique Protocol Identification Number
NCT05764564
Brief Title
External Body Pressure in Heart Failure With Preserved Ejection Fraction
Official Title
External Body Pressure and the Impact on Exercise in Heart Failure With Preserved Ejection
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 21, 2023 (Actual)
Primary Completion Date
January 1, 2025 (Anticipated)
Study Completion Date
January 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
The primary objective of the study is to test the impact of positive and negative body pressure on exercise capacity, symptoms, blood volume distribution and central cardiac hemodynamics in patients with heart failure and preserved ejection fraction. Aim 1 will study healthy volunteers and heart failure patients non invasively while Aim 2 will study heart failure patients invasively (intracardiac pressures).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Diastolic

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental: Patients with heart failure (Aim 1)
Arm Type
Experimental
Arm Title
Control: Healthy Volunteers (Aim 1)
Arm Type
Active Comparator
Arm Title
Experimental: Patients with heart failure (Aim 2)
Arm Type
Experimental
Intervention Type
Diagnostic Test
Intervention Name(s)
Positive or negative pressure
Intervention Description
Positive or negative pressure is applied via a closed chamber.
Primary Outcome Measure Information:
Title
change in exercise cardiac output
Description
Change in cardiac output from rest to 0 Watts exercise
Time Frame
Day 1
Secondary Outcome Measure Information:
Title
change in exercise cardiac output
Description
Change in cardiac output from rest to 20 Watts exercise
Time Frame
Day 1
Title
change in heart rate
Description
Change in heart rate from rest to 0 Watts exercise
Time Frame
Day 1
Title
change in heart rate
Description
Change in heart rate from rest to 20 Watts exercise
Time Frame
Day 1
Title
change in respiratory rate
Description
Change in heart rate from rest to 20 Watts exercise
Time Frame
Day 1
Title
change in O2 consumption
Description
Change in O2 consumption from rest to 0 Watts exercise
Time Frame
Day 1
Title
change in O2 consumption
Description
Change in O2 consumption from rest to 20 Watts exercise
Time Frame
Day 1
Title
Change in wedge pressure
Description
Change in wedge pressure from rest to 0 Watts exercise
Time Frame
Day 1
Title
Change in wedge pressure
Description
Change in wedge pressure from rest to 20 Watts exercise
Time Frame
Day 1
Other Pre-specified Outcome Measures:
Title
Symptom burden
Description
from rest to peak exertion we will assess symptom burden with dyspnea scales
Time Frame
Day 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Heart Failure Study Population Inclusion Criteria (Aim 1 and 2): Age greater than or equal to 30 yrs Established diagnosis of HFpEF with left ventricular ejection fraction greater than or equal to 50% NYHA II-III symptoms Stable HF drug regimen for the preceding 1 month Wedge pressure greater than or equal to 15 mmHg at rest or greater than or equal to 25 mmHg with peak exercise (For Aim 2 only) Scheduled for an elective right heart catheterization at Duke University Hospital. Exclusion Criteria (Aim 1 and 2): HF hospitalization for type I myocardial infarction within 3 months Infiltrative (ie amyloid) or hypertrophic cardiomyopathy Uncontrolled atrial or ventricular arrhythmia Chronic oxygen use History of vasovagal syncope Considered inappropriate to participate by PI or Sub-I Healthy Volunteers (Controls) Inclusion Criteria (Aim 1): Age greater than or equal to 30 yrs Able to speak English Ambulatory [assistive devices ok] Able to provide informed consent Exclusion Criteria (Aim 1): Acute myocardial infarction (3-5 days) Unstable angina Uncontrolled arrhythmia causing symptoms or haemodynamic compromise Syncope Active endocarditis Acute myocarditis or pericarditis Symptomatic severe aortic aneurysm Uncontrolled asthma Arterial desaturation at rest on room air <85% Untreated left main stem coronary stenosis Asymptomatic severe aortic stenosis Severe untreated arterial hypertension at rest (>200 mm Hg systolic, >120 mm Hg diastolic) Tachyarrhythmias or bradyarrhythmias Hypertrophic cardiomyopathy Significant pulmonary hypertension Thrombosis of the lower extremity until treated for a minimum of 2 weeks Within 2 weeks of acute symptomatic pulmonary embolus Abdominal aortic aneurysm >8.0 cm Electrolyte abnormalities Pregnancy Inmate of correctional facility (i.e. prisoner) Diagnosed history of dementia Inability to ambulate independently Considered inappropriate to participate by Principal Investigator
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marat Fudim
Phone
9196815816
Email
marat.fudim@duke.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hemming
Organizational Affiliation
Duke
Official's Role
Study Chair
Facility Information:
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ashley Burke
First Name & Middle Initial & Last Name & Degree
Marat Fudim, MD
First Name & Middle Initial & Last Name & Degree
David MacLeod, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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External Body Pressure in Heart Failure With Preserved Ejection Fraction

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