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.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts

Official record

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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

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

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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.

Sweden1 site

Skåne University Hospital Lund
Lund, 22158

Other trials in Sweden

About this study

Official title: Physiological Mechanisms Affecting Exercise Capacity in Patients With Heart Failure - an Exercise Intervention Study Evaluated With Several Modalities

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 groups in NCT05255172
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.

1 Jun 202231 Dec 2027

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)

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

Interested in taking part?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

Recruiting
PrEcision Pacing in HFpEF: the PEP-HFpEF Trial
Heart Failure and Preserved Ejection Fraction, Heart Failure New York Heart Association Class III

All Heart Failure New York Heart Association (NYHA) Class II trials