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Exercise Training to Improve Cardiopulmonary Hemodynamics in Heart Failure Patients

Primary Purpose

Heart Failure, Pulmonary Hypertension

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exercise Training
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Heart Failure focused on measuring Exercise training, Right ventricle, Exercise capacity, Quality of life

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • NYHA functional class I-IIIb.
  • LVEF < 40%.
  • Clinically-stable for > 3 months [no change in disease status or medication].
  • Willing and able to provide written informed consent and perform cycle-ergometer or treadmill based exercise.

Exclusion Criteria:

  • NYHA class IV HF.
  • Diagnosis of diastolic HF.
  • Comorbidities such as obesity (BMI >36), uncontrolled systemic hypertension, type 2 diabetes, and COPD (FEV1 <50%).
  • Musculoskeletal or other conditions that would limit exercise participation.
  • Pregnant or nursing women

Sites / Locations

  • Mayo Clinic in FloridaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Exercise Training

Control Groups

Arm Description

Two sets of exercise testing (before and after) 10 weeks of supervised exercise training (3 sessions per week) at Mayo Clinic Florida.

Two sets of exercise testing while continuing with standard medical care in between.

Outcomes

Primary Outcome Measures

Maximal oxygen uptake (VO2max) measured in mL/kg/min
VO2max is the maximal measured oxygen uptake during a symptom limited exercise test.

Secondary Outcome Measures

Mean pulmonary arterial pressure (mPAP) measured in mmHg
mPAP will be measured at rest and during exercise and is a measure of pulmonary vascular pressure.
Pulmonary vascular resistance (PVR) measured in dynes
PVR will be measured at rest and during exercise and is a measure of pulmonary hemodynamic function.
Right ventricular contractile function measured as % fractional area change (RV FAC).
RV FAC is a measure of overall contractile function of the right ventricle.
Left ventricular contractile function measured as % fractional area change (LV FAC).
LV FAC is a measure of overall contractile function of the left ventricle.
Slope of the relationship between mean pulmonary arterial pressure and cardiac output (mPAP-Q slope) measured in mmHg/L/min.
The mPAP-Q slope during exercise is a measure of the pulmonary hemodynamic response to exercise. A slope >3 is 'abnormal', and a steeper slope is related to poorer pulmonary hemodynamic function.

Full Information

First Posted
May 26, 2021
Last Updated
October 3, 2023
Sponsor
Mayo Clinic
Collaborators
Florida Heart Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT04909008
Brief Title
Exercise Training to Improve Cardiopulmonary Hemodynamics in Heart Failure Patients
Official Title
Exercise Training to Improve Pulmonary Haemodynamic and Right Ventricular Function in Heart Failure Patients With Pulmonary Hypertension
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 2023 (Anticipated)
Primary Completion Date
August 2025 (Anticipated)
Study Completion Date
August 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
Collaborators
Florida Heart Research Institute

4. Oversight

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

5. Study Description

Brief Summary
This research study is being done to find out if exercise therapy can help improve the heart function, overall health, and quality of life of patients with pulmonary hypertension caused by heart failure.
Detailed Description
The purpose of this research is to see if taking part in structured exercise training will improve the ability to exercise, the function of the heart, and the function of the blood vessels that supply the lungs in patients with heart failure and pulmonary hypertension. After enrollment all patients will complete exercise testing. Patients will be randomized to either 10 weeks of exercise training (3 times per week) or will continue standard medical care. All patients will undergo detailed exercise testing before and after the intervention.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Pulmonary Hypertension
Keywords
Exercise training, Right ventricle, Exercise capacity, Quality of life

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized control trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Exercise Training
Arm Type
Experimental
Arm Description
Two sets of exercise testing (before and after) 10 weeks of supervised exercise training (3 sessions per week) at Mayo Clinic Florida.
Arm Title
Control Groups
Arm Type
No Intervention
Arm Description
Two sets of exercise testing while continuing with standard medical care in between.
Intervention Type
Other
Intervention Name(s)
Exercise Training
Other Intervention Name(s)
Cardiac Rehab
Intervention Description
10 weeks of supervised exercise training, 3 sessions per week at the cardiac rehab clinic at Mayo Clinic Florida.
Primary Outcome Measure Information:
Title
Maximal oxygen uptake (VO2max) measured in mL/kg/min
Description
VO2max is the maximal measured oxygen uptake during a symptom limited exercise test.
Time Frame
10 weeks
Secondary Outcome Measure Information:
Title
Mean pulmonary arterial pressure (mPAP) measured in mmHg
Description
mPAP will be measured at rest and during exercise and is a measure of pulmonary vascular pressure.
Time Frame
10 weeks
Title
Pulmonary vascular resistance (PVR) measured in dynes
Description
PVR will be measured at rest and during exercise and is a measure of pulmonary hemodynamic function.
Time Frame
10 weeks
Title
Right ventricular contractile function measured as % fractional area change (RV FAC).
Description
RV FAC is a measure of overall contractile function of the right ventricle.
Time Frame
10 weeks
Title
Left ventricular contractile function measured as % fractional area change (LV FAC).
Description
LV FAC is a measure of overall contractile function of the left ventricle.
Time Frame
10 weeks
Title
Slope of the relationship between mean pulmonary arterial pressure and cardiac output (mPAP-Q slope) measured in mmHg/L/min.
Description
The mPAP-Q slope during exercise is a measure of the pulmonary hemodynamic response to exercise. A slope >3 is 'abnormal', and a steeper slope is related to poorer pulmonary hemodynamic function.
Time Frame
10 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: NYHA functional class I-IIIb. LVEF < 40%. Clinically-stable for > 3 months [no change in disease status or medication]. Willing and able to provide written informed consent and perform cycle-ergometer or treadmill based exercise. Exclusion Criteria: NYHA class IV HF. Diagnosis of diastolic HF. Comorbidities such as obesity (BMI >36), uncontrolled systemic hypertension, type 2 diabetes, and COPD (FEV1 <50%). Musculoskeletal or other conditions that would limit exercise participation. Pregnant or nursing women
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Erika Douglass, MPH
Phone
(904) 953-6595
Email
douglass.erika@mayo.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Robyn Bryde, MD
Phone
(904) 953 -7274
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bryan J Taylor, PhD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Florida
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials

Learn more about this trial

Exercise Training to Improve Cardiopulmonary Hemodynamics in Heart Failure Patients

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