Heart FailureNCT04909008
Exercise Training to Improve Cardiopulmonary Hemodynamics in Heart Failure Patients
A study testing Exercise Training in people with Heart Failure and Pulmonary Hypertension, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Pulmonary Hypertension
- What is being tested?
- Exercise Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2024to 1 Dec 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Exercise Training to Improve Pulmonary Haemodynamic and Right Ventricular Function in Heart Failure Patients With Pulmonary Hypertension
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.
Read the 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.
- Conditions
- Heart Failure, Pulmonary Hypertension
- Being tested
- Exercise Training
- Keywords
- Exercise training, Right ventricle, Exercise capacity, Quality of life
- Medical subject headings
- Heart Failure, Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise TrainingOther
Also called Cardiac Rehab
10 weeks of supervised exercise training, 3 sessions per week at the cardiac rehab clinic at Mayo Clinic Florida.
| Study group | Role | What they receive |
|---|---|---|
| Exercise Training | Experimental | Two sets of exercise testing (before and after) 10 weeks of supervised exercise training (3 sessions per week) at Mayo Clinic Florida. Receives: Other: Exercise Training |
| Control Groups | No intervention | Two sets of exercise testing while continuing with standard medical care in between. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal oxygen uptake (VO2max) measured in mL/kg/min
VO2max is the maximal measured oxygen uptake during a symptom limited exercise test.
Measured: 10 weeks
Secondary outcomes (5)
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.
Measured: 10 weeks
Pulmonary vascular resistance (PVR) measured in dynes
PVR will be measured at rest and during exercise and is a measure of pulmonary hemodynamic function.
Measured: 10 weeks
Right ventricular contractile function measured as % fractional area change (RV FAC).
RV FAC is a measure of overall contractile function of the right ventricle.
Measured: 10 weeks
Left ventricular contractile function measured as % fractional area change (LV FAC).
LV FAC is a measure of overall contractile function of the left ventricle.
Measured: 10 weeks
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.
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2021
- Study start1 Jan 2024
- Primary completion1 Apr 2025
- Study completion1 Dec 2026 (estimated)
Why it stopped: Lack of recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized control trial
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Florida Heart Research Institute
- Responsible party
- Principal investigator, Bryan Taylor, Mayo Clinic
- Investigators
- Bryan J Taylor, PhD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04909008
- Sponsor's protocol ID
- 20-011347
- Status last verified
- Apr 2026
- First submitted
- 26 May 2021
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise Training to Improve Pulmonary Haemodynamic and Right Ventricular Function in Heart Failure Patients With Pulmonary Hypertension
- ClinicalTrials.gov ID
- NCT04909008
- Acronym / sponsor ID
- 20-011347
- Conditions
- Heart Failure, Pulmonary Hypertension
- Keywords
- Exercise training, Right ventricle, Exercise capacity, Quality of life
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Lack of recruitment
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- Florida Heart Research Institute
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Apr 2025 (actual)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 1 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized control trial
| Arm | Type | Receives |
|---|---|---|
| Exercise Training | Experimental | Other: Exercise TrainingTwo sets of exercise testing (before and after) 10 weeks of supervised exercise training (3 sessions per week) at Mayo Clinic Florida. |
| Control Groups | No intervention | –Two sets of exercise testing while continuing with standard medical care in between. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise TrainingAlso: Cardiac Rehab10 weeks of supervised exercise training, 3 sessions per week at the cardiac rehab clinic at Mayo Clinic Florida. | Other | Exercise Training |
Primary outcome
Maximal oxygen uptake (VO2max) measured in mL/kg/min
Time frame: 10 weeks
VO2max is the maximal measured oxygen uptake during a symptom limited exercise test.
5 secondary outcomes
Mean pulmonary arterial pressure (mPAP) measured in mmHg
Time frame: 10 weeks
Pulmonary vascular resistance (PVR) measured in dynes
Time frame: 10 weeks
Right ventricular contractile function measured as % fractional area change (RV FAC).
Time frame: 10 weeks
Left ventricular contractile function measured as % fractional area change (LV FAC).
Time frame: 10 weeks
Slope of the relationship between mean pulmonary arterial pressure and cardiac output (mPAP-Q slope) measured in mmHg/L/min.
Time frame: 10 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bryan J Taylor, PhD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise Training in people with Heart Failure and Pulmonary Hypertension, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximal oxygen uptake (VO2max) measured in mL/kg/min (time frame: 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2026; AzTrials last refreshed its copy on 7 Nov 2026.