Heart Failure With Preserved Ejection FractionTraining-HRNCT05649787
Effects of a Supervised Training Program on Functional Capacity in Patients With HFpEF and Chronotropic Incompetence
A study testing Supervised aerobic training, Supervised aerobic plus low to moderate-intensity strength training and Supervised aerobic plus moderate to high-intensity strength training in people with Heart Failure With Preserved Ejection Fraction and Chronotropic Incompetence, run by Fundación para la Investigación del Hospital Clínico de Valencia at 1 site in Spain.
Trial summary
This is a prospective study, blinded for the evaluator, randomized (1:1:1:1) to receive standard management alone or combined with a program of training (aerobic alone or combined with strength exercises) that will be carried out in a single centre. After randomization, patients will be clinically evaluated. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Heart Failure With Preserved Ejection Fraction, Chronotropic Incompetence
- What is being tested?
- Supervised aerobic training, Supervised aerobic plus low to moderate-intensity strength training and Supervised aerobic plus moderate to high-intensity strength training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteSpain
- Study dates
- 18 Jan 2023to 31 Dec 2024
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed with heart failure with preserved ejection fraction according to 2021 ESC guidelines for Heart Failure.
- N-terminal pro-B-type natriuretic peptide (NT-proBNP) >125 pg/mL in the last month
- Stable symptomatic heart failure patients (New York Heart Association functional class II-III/IV) during the last month
- Age ≥ 60 years old.
- Blunted heart rate (HR) response during a maximal cardiopulmonary exercise testing (CPET), defined as a chronotropic index <0.62 if previous treatment with Beta-blockers or chronotropic index <0.80 in patients without beta-blockers. Chronotropic index= [HRpeak exercise - HRrest] / [220 - age - HRrest]
Who cannot join
- Inability to perform a valid baseline cardiopulmonary exercise test
- Cardiac pacemaker
- Significant primary moderate-to-severe valve disease
- Effort angina or signs of ischemia during CPET
- Primary cardiomyopathies
- Cardiac transplantation
- Any other comorbidity with a life expectancy of less than one year
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of a Supervised Training Program on Functional Capacity in Patients With Heart Failure and Preserved Ejection Function and Chronotropic Incompetence
This is a prospective study, blinded for the evaluator, randomized (1:1:1:1) to receive standard management alone or combined with a program of training (aerobic alone or combined with strength exercises) that will be carried out in a single centre. After randomization, patients will be clinically evaluated. The primary endpoint (peakVO2) will be assessed by cardiopulmonary exercise testing (CPET) at 12 weeks. Patients with heart failure with preserved ejection fraction, functional class NYHA II-III, and chronotropic incompetence criteria will be enrolled. A sample size estimation [alfa: 0.05, power: 80%, a 15% loss rate, and at least a delta change of mean peakVO2: +2,4 mL/kg/min (SD±2)] of 80 patients (20 per arm) would be necessary to test our hypothesis.
Read the detailed description
Heart failure with preserved ejection fraction (HFpEF) is a highly prevalent clinical entity that predominantly affects women >60 years old, whose incidence has increased in the last decade and has a complex and multifactorial pathophysiology. Chronotropic incompetence (CrI) has emerged as a crucial mechanism, particularly in patients older than 60 years, and is associated with more significant functional impairment. Supervised training programs in patients with heart failure and reduced ejection fraction and CrI have improved functional capacity and chronotropic response. However, we do not have evidence about the effects of a supervised training program on patients with HFpEF and CrI. This work aims to evaluate the effect of a supervised exercise program for 12 weeks in patients with HFpEF and CrI on peak oxygen consumption (peakVO2) and chronotropic response.
This is a prospective study, blinded for the evaluator, randomized (1:1:1:1) to receive standard management alone or combined with a program of training (aerobic alone or combined with strength exercises) that will be carried out in a single centre. After randomization, patients will be clinically evaluated. The primary endpoint (peakVO2) will be assessed by cardiopulmonary exercise testing (CPET) at 12 weeks. Patients with HFpEF, functional class NYHA II-III, and CrI criteria will be enrolled. A sample size estimation [alfa: 0.05, power: 80%, a 15% loss rate, and at least a delta change of mean peakVO2: +2,4 mL/kg/min (SD±2)] of 80 patients (20 per arm) would be necessary to test our hypothesis.
- Being tested
- Supervised aerobic training, Supervised aerobic plus low to moderate-intensity strength training, Supervised aerobic plus moderate to high-intensity strength training
- Keywords
- Heart Failure with Preserved Ejection Fraction, Chronotropic incompetence, Functional capacity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supervised aerobic trainingBehavioural
Supervised moderate to high-intensity interval aerobic training
Supervised aerobic plus low to moderate-intensity strength trainingBehavioural
Supervised moderate to high-intensity interval aerobic training plus low to moderate-intensity strength training
Supervised aerobic plus moderate to high-intensity strength trainingBehavioural
Supervised moderate to high-intensity interval aerobic training plus moderate to high-intensity strength training
| Study group | Role | What they receive |
|---|---|---|
| Usual care | No intervention | Patients allocated to this arm will receive the usual care plus explicit recommendations for home-based aerobic and strength training. |
| Supervised aerobic training | Active comparator | Patients allocated to this arm will receive the usual care plus supervised aerobic training Receives: Behavioral: Supervised aerobic training |
| Supervised aerobic plus low to moderate-intensity strenght training | Active comparator | Patients allocated to this arm will receive the usual care plus supervised aerobic and low to moderate-intensity strength training Receives: Behavioral: Supervised aerobic training; Behavioral: Supervised aerobic plus low to moderate-intensity strength training |
| Supervised aerobic plus moderate to high-intensity strenght training | Active comparator | Patients allocated to this arm will receive the usual care plus supervised aerobic and moderate to high-intensity strength training. Receives: Behavioral: Supervised aerobic training; Behavioral: Supervised aerobic plus moderate to high-intensity strength training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak oxygen consumption
Maximal functional capacity will be evaluated using incremental and symptom-limited cardiopulmonary exercise testing on a bicycle ergometer, beginning with a workload of 10 W and increasing gradually in a ramp protocol at 10-W increments every 1 minute. We define maximal functional capacity as when the patient stops pedalling because of symptoms and the respiratory exchange ratio (RER) was >1. During exercise, patients will be monitored with 12-lead electrocardiogram and blood pressure measurements every 2 minutes. Gas exchange data and cardiopulmonary variables were averages of values taken every 10 seconds. Peak oxygen consumption (PeakVO2) was defined as the highest value of VO2 during the last 20 seconds of exercise.
Primary outcome: changes in peak oxygen consumption between and within groups at 12-week Unit of measure of peak oxygen consumption: mL/kg/min
Measured: Peak oxygen consumption will be evaluated at first visit and after 3 months. We will evaluate peak oxygen consumption change from baseline.
Secondary outcomes (2)
Chronotropic response
Heart rate (HR) response during the maximal cardiopulmonary exercise testing will be evaluated following the chronotropic index (CIx) formula. The chronotropic index is evaluated by the following formula, including heart rate at peak effort, heart rate at rest and age. Chronotropic index: (peak heart rate-rest heart rate)/ [220-age-rest heart rate)].
Secondary outcome: changes in chronotropic response in between and within groups at 12-week Heart rate unit: beats per minute Age unit: years The chronotropic index has no units of measure.
Measured: Chronotropic index will be evaluated at first visit and after 3 months. We will evaluate chronotropic index change from baseline.
Kansas City Cardiomyopathy Questionnaire Scales
The Kansas City Cardiomyopathy Questionnaire includes 23 items that map to 7 domains: symptom frequency, symptom burden, symptom stability, physical limitations, social limitations, quality of life, and self-efficacy (the patient's understanding of how to manage their heart failure). All Kansas City Cardiomyopathy Questionnaire domains are scaled from 0 to 100, 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.
A change of 5 points is considered to be a small but clinically important change, whereas changes of 10 and 20 points are considered moderate-to-large and large-to-very-large clinical changes.
Measured: The Kansas City Cardiomyopathy Questionnaire will be evaluated at first visit and after 3 months. We will evaluate the Kansas City Cardiomyopathy Questionnaire change from baseline.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2022
- Study start18 Jan 2023
- Primary completion18 Nov 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Heart Failure With Preserved Ejection FractionStudies 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
- Model description
- This is a prospective study, blinded for the evaluator, randomized (1:1:1:1) to receive standard management alone or combined with a program of training (aerobic alone or combined with strength exercises) that will be carried out in a single centre.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundación para la Investigación del Hospital Clínico de Valencia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Patricia Palau, MD, PhD, Principal investigator, Instituto de Investigacion Sanitaria INCLIVA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05649787
- Sponsor's protocol ID
- Training-HR
- Acronym
- Training-HR
- Status last verified
- Feb 2025
- First submitted
- 22 Nov 2022
- Last updated
- 27 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Palau P, de Amo I, Nunez G, Flor C, de la Espriella R, Garcia-Conejo C, Berlanga-Tovar SE, Casana-Granell J, Calatayud J, Dominguez E, Sanchis-Gomar F, Meyer M, Sanchis J, Nunez J, Lopez L. Effect of exercise training in patients with chronotropic incompetence and heart failure with preserved ejection fraction: the TRAINING-HR randomized clinical trial. Eur J Prev Cardiol. 2026 Feb 3;33(2):265-275. doi: 10.1093/eurjpc/zwaf269.
PubMed 40294211Palau P, Nunez J, Dominguez E, de la Espriella R, Nunez G, Flor C, de Amo I, Casana J, Calatayud J, Ortega L, Marin P, Sanchis J, Sanchis-Gomar F, Lopez L. Effect of exercise training in patients with chronotropic incompetence and heart failure with preserved ejection fraction: Training-HR study protocol. Curr Probl Cardiol. 2024 Dec;49(12):102839. doi: 10.1016/j.cpcardiol.2024.102839. Epub 2024 Sep 4.
PubMed 39242065
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Supervised Training Program on Functional Capacity in Patients With Heart Failure and Preserved Ejection Function and Chronotropic Incompetence
- ClinicalTrials.gov ID
- NCT05649787
- Acronym / sponsor ID
- Training-HR / Training-HR
- Keywords
- Heart Failure with Preserved Ejection Fraction, Chronotropic incompetence, Functional capacity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Fundación para la Investigación del Hospital Clínico de ValenciaUniversity, hospital or other
- Study start
- 18 Jan 2023 (actual)
- Primary completion
- 18 Nov 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 14 Dec 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.
This is a prospective study, blinded for the evaluator, randomized (1:1:1:1) to receive standard management alone or combined with a program of training (aerobic alone or combined with strength exercises) that will be carried out in a single centre. After randomization, patients will be clinically evaluated. The primary endpoint (peakVO2) will be assessed by cardiopulmonary exercise testing (CPET) at 12 weeks. Patients with heart failure with preserved ejection fraction, functional class NYHA II-III, and chronotropic incompetence criteria will be enrolled. A sample size estimation [alfa: 0.05, power: 80%, a 15% loss rate, and at least a delta change of mean peakVO2: +2,4 mL/kg/min (SD±2)] of 80 patients (20 per arm) would be necessary to test our hypothesis.
Detailed description
Heart failure with preserved ejection fraction (HFpEF) is a highly prevalent clinical entity that predominantly affects women >60 years old, whose incidence has increased in the last decade and has a complex and multifactorial pathophysiology. Chronotropic incompetence (CrI) has emerged as a crucial mechanism, particularly in patients older than 60 years, and is associated with more significant functional impairment. Supervised training programs in patients with heart failure and reduced ejection fraction and CrI have improved functional capacity and chronotropic response. However, we do not have evidence about the effects of a supervised training program on patients with HFpEF and CrI. This work aims to evaluate the effect of a supervised exercise program for 12 weeks in patients with HFpEF and CrI on peak oxygen consumption (peakVO2) and chronotropic response.
This is a prospective study, blinded for the evaluator, randomized (1:1:1:1) to receive standard management alone or combined with a program of training (aerobic alone or combined with strength exercises) that will be carried out in a single centre. After randomization, patients will be clinically evaluated. The primary endpoint (peakVO2) will be assessed by cardiopulmonary exercise testing (CPET) at 12 weeks. Patients with HFpEF, functional class NYHA II-III, and CrI criteria will be enrolled. A sample size estimation [alfa: 0.05, power: 80%, a 15% loss rate, and at least a delta change of mean peakVO2: +2,4 mL/kg/min (SD±2)] of 80 patients (20 per arm) would be necessary to test our hypothesis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 4
- Model description
- This is a prospective study, blinded for the evaluator, randomized (1:1:1:1) to receive standard management alone or combined with a program of training (aerobic alone or combined with strength exercises) that will be carried out in a single centre.
| Arm | Type | Receives |
|---|---|---|
| Usual care | No intervention | –Patients allocated to this arm will receive the usual care plus explicit recommendations for home-based aerobic and strength training. |
| Supervised aerobic training | Active comparator | Behavioral: Supervised aerobic trainingPatients allocated to this arm will receive the usual care plus supervised aerobic training |
| Supervised aerobic plus low to moderate-intensity strenght training | Active comparator | Behavioral: Supervised aerobic training, Behavioral: Supervised aerobic plus low to moderate-intensity strength trainingPatients allocated to this arm will receive the usual care plus supervised aerobic and low to moderate-intensity strength training |
| Supervised aerobic plus moderate to high-intensity strenght training | Active comparator | Behavioral: Supervised aerobic training, Behavioral: Supervised aerobic plus moderate to high-intensity strength trainingPatients allocated to this arm will receive the usual care plus supervised aerobic and moderate to high-intensity strength training. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients diagnosed with heart failure with preserved ejection fraction according to 2021 ESC guidelines for Heart Failure.
- N-terminal pro-B-type natriuretic peptide (NT-proBNP) >125 pg/mL in the last month
- Stable symptomatic heart failure patients (New York Heart Association functional class II-III/IV) during the last month
- Age ≥ 60 years old.
- Blunted heart rate (HR) response during a maximal cardiopulmonary exercise testing (CPET), defined as a chronotropic index <0.62 if previous treatment with Beta-blockers or chronotropic index <0.80 in patients without beta-blockers. Chronotropic index= [HRpeak exercise - HRrest] / [220 - age - HRrest]
Key exclusion criteria (7 listed)
- Inability to perform a valid baseline cardiopulmonary exercise test
- Cardiac pacemaker
- Significant primary moderate-to-severe valve disease
- Effort angina or signs of ischemia during CPET
- Primary cardiomyopathies
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 aerobic trainingSupervised moderate to high-intensity interval aerobic training | Behavioural | Supervised aerobic plus low to moderate-intensity strenght training, Supervised aerobic plus moderate to high-intensity strenght training, Supervised aerobic training |
| Supervised aerobic plus low to moderate-intensity strength trainingSupervised moderate to high-intensity interval aerobic training plus low to moderate-intensity strength training | Behavioural | Supervised aerobic plus low to moderate-intensity strenght training |
| Supervised aerobic plus moderate to high-intensity strength trainingSupervised moderate to high-intensity interval aerobic training plus moderate to high-intensity strength training | Behavioural | Supervised aerobic plus moderate to high-intensity strenght training |
Primary outcome
Peak oxygen consumption
Time frame: Peak oxygen consumption will be evaluated at first visit and after 3 months. We will evaluate peak oxygen consumption change from baseline.
Maximal functional capacity will be evaluated using incremental and symptom-limited cardiopulmonary exercise testing on a bicycle ergometer, beginning with a workload of 10 W and increasing gradually in a ramp protocol at 10-W increments every 1 minute. We define maximal functional capacity as when the patient stops pedalling because of symptoms and the respiratory exchange ratio (RER) was >1. During exercise, patients will be monitored with 12-lead electrocardiogram and blood pressure measurements every 2 minutes. Gas exchange data and cardiopulmonary variables were averages of values taken every 10 seconds. Peak oxygen consumption (PeakVO2) was defined as the highest value of VO2 during the last 20 seconds of exercise. Primary outcome: changes in peak oxygen consumption between and within groups at 12-week Unit of measure of peak oxygen consumption: mL/kg/min
2 secondary outcomes
Chronotropic response
Time frame: Chronotropic index will be evaluated at first visit and after 3 months. We will evaluate chronotropic index change from baseline.
Kansas City Cardiomyopathy Questionnaire Scales
Time frame: The Kansas City Cardiomyopathy Questionnaire will be evaluated at first visit and after 3 months. We will evaluate the Kansas City Cardiomyopathy Questionnaire change from baseline.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2025.
- Derived from this study: PubMed 40294211Palau P, de Amo I, Nunez G, Flor C, de la Espriella R, Garcia-Conejo C, Berlanga-Tovar SE, Casana-Granell J, Calatayud J, Dominguez E, Sanchis-Gomar F, Meyer M, Sanchis J, Nunez J, Lopez L. Effect of exercise training in patients with chronotropic incompetence and heart failure with preserved ejection fraction: the TRAINING-HR randomized clinical trial. Eur J Prev Cardiol. 2026 Feb 3;33(2):265-275. doi: 10.1093/eurjpc/zwaf269.
- Derived from this study: PubMed 39242065Palau P, Nunez J, Dominguez E, de la Espriella R, Nunez G, Flor C, de Amo I, Casana J, Calatayud J, Ortega L, Marin P, Sanchis J, Sanchis-Gomar F, Lopez L. Effect of exercise training in patients with chronotropic incompetence and heart failure with preserved ejection fraction: Training-HR study protocol. Curr Probl Cardiol. 2024 Dec;49(12):102839. doi: 10.1016/j.cpcardiol.2024.102839. Epub 2024 Sep 4.
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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.
Patricia Palau, MD, PhD principal investigator
Instituto de Investigacion Sanitaria INCLIVA
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 aerobic training, Supervised aerobic plus low to moderate-intensity strength training and Supervised aerobic plus moderate to high-intensity strength training in people with Heart Failure With Preserved Ejection Fraction and Chronotropic Incompetence, run by Fundación para la Investigación del Hospital Clínico de Valencia at 1 site in Spain.
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 7 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: finished, as of the sponsor's last update on 27 Feb 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 Spain. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Peak oxygen consumption (time frame: Peak oxygen consumption will be evaluated at first visit and after 3 months. We will evaluate peak oxygen consumption change from baseline.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05649787, which also lists 2 linked publications.
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 27 Feb 2025.