NCT05764564

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).

Trial Health

57
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 25, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 10, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

April 21, 2023

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2025

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

September 11, 2026

Completed
Last Updated

September 11, 2026

Status Verified

August 1, 2026

Enrollment Period

2.1 years

First QC Date

February 25, 2023

Results QC Date

May 20, 2026

Last Update Submit

August 18, 2026

Conditions

Heart Failure, Diastolic

Outcome Measures

Primary Outcomes (2)

  • Change in Oxygen (O2) Consumption From Rest to 20 Watts Exercise

    A positive value indicates greater O2 consumption.

    Day 1

  • Change in Cardiac Output From Rest to 0 Watts Exercise

    Day 1

Secondary Outcomes (8)

  • Change in Cardiac Output From Rest to 20 Watts Exercise

    Day 1

  • Change in Heart Rate From Rest to 0 Watts Exercise

    Day 1

  • Change in Heart Rate From Rest to 20 Watts Exercise

    Day 1

  • Change in Respiration From Rest to 20 Watts Exercise

    Day 1

  • Change in O2 Consumption From Rest to 0 Watts Exercise

    Day 1

  • +3 more secondary outcomes

Study Arms (3)

Experimental: Patients with heart failure (Aim 1)

EXPERIMENTAL
Diagnostic Test: Positive or negative pressure

Control: Healthy Volunteers (Aim 1)

ACTIVE COMPARATOR
Diagnostic Test: Positive or negative pressure

Experimental: Patients with heart failure (Aim 2)

EXPERIMENTAL
Diagnostic Test: Positive or negative pressure

Interventions

Positive or negative pressureDIAGNOSTIC_TEST

Positive or negative pressure is applied via a closed chamber.

Control: Healthy Volunteers (Aim 1)Experimental: Patients with heart failure (Aim 1)Experimental: Patients with heart failure (Aim 2)

Eligibility Criteria

Age30 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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)
  • Age greater than or equal to 30 yrs
  • Able to speak English
  • Ambulatory \[assistive devices ok\]
  • Able to provide informed consent
  • Acute myocardial infarction (3-5 days)
  • Unstable angina
  • Uncontrolled arrhythmia causing symptoms or haemodynamic compromise
  • Syncope
  • +20 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Heart Failure, Diastolic

Interventions

Gene Expression

Condition Hierarchy (Ancestors)

Heart FailureHeart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Genetic Phenomena

Limitations and Caveats

Certain prespecified outcomes metrics were unobtainable such as cardiac output and wedge pressure given the non invasive experimental set up. Aim 2 of the protocol was not executed as the study was terminated after completion of Aim 1.

Results Point of Contact

Title
Marat Fudim
Organization
Duke
marat.fudim@duke.edu
919-823-5364

Study Officials

  • Hemming

    Duke

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 25, 2023

First Posted

March 10, 2023

Study Start

April 21, 2023

Primary Completion

May 31, 2025

Study Completion

May 31, 2025

Last Updated

September 11, 2026

Results First Posted

September 11, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)