External Body Pressure in Heart Failure With Preserved Ejection Fraction

• Sponsor: Duke University (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05764564
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arms: 3
• Anticipated Duration (Months): 21.1
• Patients Per Site Per Month: 2.8

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Heart Failure, Diastolic	Diagnostic Test: Positive or negative pressure	Phase 1/Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 60 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: External Body Pressure and the Impact on Exercise in Heart Failure With Preserved Ejection
• Anticipated Study Start Date: Mar 30, 2023
• Anticipated Primary Completion Date: Jan 1, 2025
• Anticipated Study Completion Date: Jan 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Experimental: Patients with heart failure (Aim 1)	Diagnostic Test: Positive or negative pressure; Positive or negative pressure is applied via a closed chamber.
Active Comparator: Control: Healthy Volunteers (Aim 1)	Diagnostic Test: Positive or negative pressure; Positive or negative pressure is applied via a closed chamber.
Experimental: Experimental: Patients with heart failure (Aim 2)	Diagnostic Test: Positive or negative pressure; Positive or negative pressure is applied via a closed chamber.

Outcome Measures

Primary Outcome Measures

1. change in exercise cardiac output [Day 1]

   Change in cardiac output from rest to 0 Watts exercise

Secondary Outcome Measures

1. change in exercise cardiac output [Day 1]

   Change in cardiac output from rest to 20 Watts exercise

2. change in heart rate [Day 1]

   Change in heart rate from rest to 0 Watts exercise

3. change in heart rate [Day 1]

   Change in heart rate from rest to 20 Watts exercise

4. change in respiratory rate [Day 1]

   Change in heart rate from rest to 20 Watts exercise

5. change in O2 consumption [Day 1]

   Change in O2 consumption from rest to 0 Watts exercise

6. change in O2 consumption [Day 1]

   Change in O2 consumption from rest to 20 Watts exercise

7. Change in wedge pressure [Day 1]

   Change in wedge pressure from rest to 0 Watts exercise

8. Change in wedge pressure [Day 1]

   Change in wedge pressure from rest to 20 Watts exercise

Other Outcome Measures

1. Symptom burden [Day 1]

   from rest to peak exertion we will assess symptom burden with dyspnea scales

Eligibility Criteria

Criteria

• Ages Eligible for Study: 30 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Duke University Medical Center	Durham	North Carolina	United States	27710

Sponsors and Collaborators

• Duke University

Investigators

• Study Chair: Hemming, Duke

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Duke University
• ClinicalTrials.gov Identifier: NCT05764564
• Other Study ID Numbers: Pro00112081
• First Posted: Mar 10, 2023
• Last Update Posted: Mar 13, 2023
• Last Verified: Mar 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Additional relevant MeSH terms: Heart Failure; Heart Failure, Diastolic

Study Results

No Results Posted as of Mar 13, 2023