Heart Failure New York Heart Association (NYHA) Class IINCT05255172
Exercise Intervention in Patients With Heart Failure With Preserved and Reduced Ejection Fraction
A study testing Supervised Exercise in people with Heart Failure New York Heart Association (NYHA) Class II and Heart Failure New York Heart Association (NYHA) Class III, run by Region Skane at 1 site in Sweden.
Trial summary
The objective of this study is to assess by what physiological mechanisms patients with heart failure benefit from exercise. Effects of an exercise intervention will be assessed for both central (heart and lungs) and peripheral (muscle fiber and mitochondria) factors. Read more about this study
- Who is it for?
- Ages 50 to 90 years
- Conditions the study is for
- Heart Failure New York Heart Association (NYHA) Class II, Heart Failure New York Heart Association (NYHA) Class III
- What is being tested?
- Supervised Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteSweden
- Study dates
- 1 Jun 2022to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 50 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signs and symptoms of heart failure
- Age ≥50 years
- Stable chronic heart failure (no hospitalizations within past month, no new medications past month)
- Able to understand and follow exercise prescription
- Currently physically inactive (less than 150 minutes/week moderate intensity exercise)
Who cannot join
- Currently or within the past 6 months been involved in cardiac rehab with exercise
- Devices or implants not compatible with magnetic resonance imaging or exercise testing
- Any orthopedic or medical condition affecting participation in testing and training
- Signs of acute ischemia during baseline cardiopulmonary exercise testing
- Participation in other clinical trials that may affect results
- Moderate or severe valvular disease
Show all 9Show fewer
- Atrial fibrillation
- Moderate or severe chronic obstructive pulmonary disease
- NYHA class IV
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Physiological Mechanisms Affecting Exercise Capacity in Patients With Heart Failure - an Exercise Intervention Study Evaluated With Several Modalities
The objective of this study is to assess by what physiological mechanisms patients with heart failure benefit from exercise. Effects of an exercise intervention will be assessed for both central (heart and lungs) and peripheral (muscle fiber and mitochondria) factors.
Read the detailed description
A randomized, non-blinded prospective intervention trial. Patients randomized to exercise intervention will undergo supervised aerobic training on ergometer cycle for 12 weeks whilst control group receives standard care. Before and after the intervention, all participants will undergo cardiac magnetic resonance imaging (cardiac MR) examinations, Ventilation/Perfusion Single Photon Emission Computed Tomography (V/P SPECT), Cardiopulmonary exercise tests, muscle biopsies and blood sampling.
- Conditions
- Heart Failure New York Heart Association (NYHA) Class II, Heart Failure New York Heart Association (NYHA) Class III
- Being tested
- Supervised Exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supervised ExerciseOther
12 weeks of supervised aerobic exercise individually adapted to exercise capacity according to a VO2 peak test
| Study group | Role | What they receive |
|---|---|---|
| Supervised exercise | Experimental | The exercise intervention will include 2 supervised sessions of ergometer cycling with a warm up period of 10 minutes and 20 minutes of cycling at the aerobic intensity below the anaerobic threshold as determined from baseline results. Patients in the exercise arm will have 1 unsupervised exercise session where the participants walk or bicycle for 30 minutes at an intensity experienced as somewhat hard (Borg 13) according to the Borg Rating of Perceived Exertion Scale. Receives: Other: Supervised Exercise |
| Standard of Care | No intervention | The control group will receive advise to continue to live as usual. After 4 and 8 weeks, participants in the control group will be contacted by telephone for inquiry of general wellbeing. No other interventions will be performed in the control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal oxygen uptake (VO2peak)
a change in maximal oxygen uptake (VO2 peak) of 2 ml/min/kg
Measured: 12 weeks intervention
Secondary outcomes (4)
Health related quality of life
Change in Health related quality of life assessed with Kansas City Cardiomyopathy Questionnaire (KCCQ). KCCQ scores are scaled from 0 to 100 and summarized in 25-point ranges, where scores represent health status as follows: 0 to 24: very poor to poor; 25 to 49: poor to fair; 50 to 74: fair to good; and 75 to 100: good to excellent.
Measured: 12 weeks intervention
Cardiac volumes and function
Change in cardiac volumes and function assessed using Cardiac MR indicating effects of the exercise intervention as compared to the control group
Measured: 12 weeks intervention
Perfusion gradients on Ventilation / Perfusion Single Photon Emission Computed Tomography (V/P SPECT)
Change in pulmonary congestion quantified by V/P SPECT
Measured: 12 weeks intervention
Mitochondrial function
Change in mitochondrial number and function using respirometry indicating effects of the exercise intervention as compared to the control group
Measured: 12 weeks intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2022
- Study start1 Jun 2022
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure New York Heart Association (NYHA) Class IIStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05255172
- Sponsor's protocol ID
- 2021-05044
- Status last verified
- Apr 2025
- First submitted
- 20 Jan 2022
- Last updated
- 29 Jun 2025
- 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 29 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physiological Mechanisms Affecting Exercise Capacity in Patients With Heart Failure - an Exercise Intervention Study Evaluated With Several Modalities
- ClinicalTrials.gov ID
- NCT05255172
- Acronym / sponsor ID
- 2021-05044
- Conditions
- Heart Failure New York Heart Association (NYHA) Class II, Heart Failure New York Heart Association (NYHA) Class III
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 24 Feb 2022 (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.
The objective of this study is to assess by what physiological mechanisms patients with heart failure benefit from exercise. Effects of an exercise intervention will be assessed for both central (heart and lungs) and peripheral (muscle fiber and mitochondria) factors.
Detailed description
A randomized, non-blinded prospective intervention trial. Patients randomized to exercise intervention will undergo supervised aerobic training on ergometer cycle for 12 weeks whilst control group receives standard care. Before and after the intervention, all participants will undergo cardiac magnetic resonance imaging (cardiac MR) examinations, Ventilation/Perfusion Single Photon Emission Computed Tomography (V/P SPECT), Cardiopulmonary exercise tests, muscle biopsies and blood sampling.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Supervised exercise | Experimental | Other: Supervised ExerciseThe exercise intervention will include 2 supervised sessions of ergometer cycling with a warm up period of 10 minutes and 20 minutes of cycling at the aerobic intensity below the anaerobic threshold as determined from baseline results. Patients in the exercise arm will have 1 unsupervised exercise session where the participants walk or bicycle for 30 minutes at an intensity experienced as somewhat hard (Borg 13) according to the Borg Rating of Perceived Exertion Scale. |
| Standard of Care | No intervention | –The control group will receive advise to continue to live as usual. After 4 and 8 weeks, participants in the control group will be contacted by telephone for inquiry of general wellbeing. No other interventions will be performed in the control group. |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Signs and symptoms of heart failure
- Age ≥50 years
- Stable chronic heart failure (no hospitalizations within past month, no new medications past month)
- Able to understand and follow exercise prescription
- Currently physically inactive (less than 150 minutes/week moderate intensity exercise)
Key exclusion criteria (9 listed)
- Currently or within the past 6 months been involved in cardiac rehab with exercise
- Devices or implants not compatible with magnetic resonance imaging or exercise testing
- Any orthopedic or medical condition affecting participation in testing and training
- Signs of acute ischemia during baseline cardiopulmonary exercise testing
- Participation in other clinical trials that may affect results
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 |
|---|---|---|
| Supervised Exercise12 weeks of supervised aerobic exercise individually adapted to exercise capacity according to a VO2 peak test | Other | Supervised exercise |
Primary outcome
Maximal oxygen uptake (VO2peak)
Time frame: 12 weeks intervention
a change in maximal oxygen uptake (VO2 peak) of 2 ml/min/kg
4 secondary outcomes
Health related quality of life
Time frame: 12 weeks intervention
Cardiac volumes and function
Time frame: 12 weeks intervention
Perfusion gradients on Ventilation / Perfusion Single Photon Emission Computed Tomography (V/P SPECT)
Time frame: 12 weeks intervention
Mitochondrial function
Time frame: 12 weeks intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2025.
- Individual participant dataSharing planned: No
Related trials for Heart Failure New York Heart Association (NYHA) Class II
Recruiting
PrEcision Pacing in HFpEF: the PEP-HFpEF Trial
Heart Failure and Preserved Ejection Fraction, Heart Failure New York Heart Association Class III
Recruiting
PROACTIVE-HF-2 Trial Heart Failure NYHA Class II and III
Heart Failure NYHA Class II, Heart Failure NYHA Class III
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supervised Exercise in people with Heart Failure New York Heart Association (NYHA) Class II and Heart Failure New York Heart Association (NYHA) Class III, run by Region Skane at 1 site in Sweden.
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 5 inclusion and 9 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: enrolling by invitation, as of the sponsor's last update on 29 Jun 2025. 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 Sweden. 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?
This study is still under way. Results are not available in the source record yet.
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 (VO2peak) (time frame: 12 weeks intervention). 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 29 Jun 2025.