Heart FailureTrain-CRNCT06640140
Effects of a Supervised Training Program on Functional Capacity in Patients With HF and Cardiorenal Syndrome
A study testing Supervised aerobic plus strength training in people with Heart Failure and Cardiorenal Syndrome, 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) to receive standard management alone or combined with a training program (aerobic combined with strength exercises) that will be carried out in a single center. After randomization, patients will be clinically evaluated. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Cardiorenal Syndrome
- What is being tested?
- Supervised aerobic plus strength training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteSpain
- Study dates
- 8 Oct 2024to Dec 2025
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed with heart failure according to 2021 ESC guidelines for Heart Failure.
- Evidence of cardiorenal syndrome, defined as coexistent very high risk chronic kidney disease (CKD) (estimated glomerular filtration rate [eGFR] \<30 ml/min/1.73m2 or eGFR 30 to 44 ml/min/1.73m2 and Urine Albumin-Creatinine Ratio [uACR] \>30 mg/g) or rapidly progressive CKD (loss of \>5 ml/min/1.73m2 in one year).
- Stable symptomatic heart failure patients (New York Heart Association functional class II-III/IV) during the last month.
- Age ≥ 18 years old.
- Willing to provide written informed consent.
Who cannot join
- Inability to perform a valid baseline cardiopulmonary exercise test.
- Significant primary severe valve disease that is considered the main symptom driver.
- 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. Contact the study team or a site near you to ask about taking part.
Spain1 site
Instituto de investigación sanitaria INCLIVA
Valencia, 46010
Patricia Fernández, PhD, +34961973536, patricia.fernandez@incliva.es
About this study
Official title: Effects of a Supervised Training Program on Functional Capacity in Patients With Heart Failure and Cardiorenal Syndrome
This is a prospective study, blinded for the evaluator, randomized (1:1) to receive standard management alone or combined with a training program (aerobic combined with strength exercises) that will be carried out in a single center. After randomization, patients will be clinically evaluated. The primary endpoint (peakVO2) will be assessed by cardiopulmonary exercise testing combined with echocardiography (echo-CPET) at 12 weeks. Ambulatory patients with heart failure and cardiorenal syndrome and functional class NYHA II-III will be enrolled. A sample size estimation [alfa: 0.05, power: 80%, a 20% loss rate, and at least a delta change of mean peakVO2: +2,4 mL/kg/min (SD±2)] of 26 patients (13 per arm) would be necessary to test our hypothesis.
Read the detailed description
Heart failure (HF) is a highly prevalent clinical entity that predominantly affects elderly people with comorbidities. Among these, chronic kidney disease is particularly frequent, complicating disease management and worsening prognosis. Supervised training programs in patients with HF have improved functional capacity and reduced hospitalizations. However, the evidence is scarce regarding the effects of a supervised training program on patients with HF and cardiorenal syndrome. This work aims to evaluate the effect of a supervised exercise program for 12 weeks in patients with HF and cardiorenal syndrome on peak oxygen consumption (peakVO2).
This is a prospective study, blinded for the evaluator, randomized (1:1) to receive standard management alone or combined with a training program (aerobic combined with strength exercises) that will be carried out in a single center. After randomization, patients will be clinically evaluated. The primary endpoint (peakVO2) will be assessed by cardiopulmonary exercise testing combined with echocardiography (echo-CPET) at 12 weeks. Ambulatory patients with heart failure and cardiorenal syndrome and functional class NYHA II-III will be enrolled. A sample size estimation [alfa: 0.05, power: 80%, a 20% loss rate, and at least a delta change of mean peakVO2: +2,4 mL/kg/min (SD±2)] of 26 patients (13 per arm) would be necessary to test our hypothesis.
- Conditions
- Heart Failure, Cardiorenal Syndrome
- Being tested
- Supervised aerobic plus strength training
- Keywords
- Heart failure, Cardiorenal Syndrome, Functional Capacity
- Medical subject headings
- Heart Failure, Cardio-Renal Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supervised aerobic plus 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 plus strenght training | Active comparator | Patients allocated to this arm will receive the usual care plus supervised aerobic and strength training. Receives: Behavioral: Supervised aerobic plus strength training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak oxygen consumption
Primary outcome: changes in peak oxygen consumption between groups at 12 weeks.
Description:
Peak oxigen consumption (also known as maximal functional capacity) will be evaluated using incremental and symptom-limited cardiopulmonary exercise testing on a semi-supine bicycle ergometer (coupled with stress echocardiography), beginning with a workload of 10 Watts and increasing gradually in a ramp protocol at 10-Watts increments every 1 minute. Peak oxygen consumption (PeakVO2) is defined as the highest value of VO2 during the last 20 seconds of exercise.
Unit of measure of peak oxygen consumption: mL/kg/min (this is a directly reported measure from the cardiopulmonary exercise testing, not an aggregated or derived calculation).
Measured: The investigators will evaluate peak oxygen consumption at baseline (week 0) and at week 12.
Secondary outcomes (2)
Kansas City Cardiomyopathy Questionnaire
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 investigators will evaluate Kansas City Cardiomyopathy Questionnaire at baseline (week 0) and at week 12.
Chronotropic index
Secondary outcome: changes in chronotropic response between groups at 12 weeks. Description: Chronotropic index is an index calculated in a maximal cardiopulmonary exercise testing to assess heart rate response to exercise. 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)]. The chronotropic index has no units of measure.
Measured: The investigators will evaluate chronotropic index at baseline (week 0) and at week 12.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start8 Oct 2024 (estimated)
- Primary completionSep 2025 (estimated)
- Study completionDec 2025 (estimated)
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.
- 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) to receive standard management alone or combined with a training program (aerobic combined with strength exercises) that will be carried out in a single center.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundación para la Investigación del Hospital Clínico de Valencia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gonzalo Núñez Marín, MD, Principal investigator, Instituto de investigación sanitaria INCLIVA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06640140
- Sponsor's protocol ID
- Train-CR
- Acronym
- Train-CR
- Status last verified
- Oct 2024
- First submitted
- 8 Oct 2024
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. 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 Cardiorenal Syndrome
- ClinicalTrials.gov ID
- NCT06640140
- Acronym / sponsor ID
- Train-CR / Train-CR
- Conditions
- Heart Failure, Cardiorenal Syndrome
- Keywords
- Heart failure, Cardiorenal Syndrome, Functional Capacity
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Fundación para la Investigación del Hospital Clínico de ValenciaUniversity, hospital or other
- Study start
- 8 Oct 2024 (estimated)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 15 Oct 2024 (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) to receive standard management alone or combined with a training program (aerobic combined with strength exercises) that will be carried out in a single center. After randomization, patients will be clinically evaluated. The primary endpoint (peakVO2) will be assessed by cardiopulmonary exercise testing combined with echocardiography (echo-CPET) at 12 weeks. Ambulatory patients with heart failure and cardiorenal syndrome and functional class NYHA II-III will be enrolled. A sample size estimation [alfa: 0.05, power: 80%, a 20% loss rate, and at least a delta change of mean peakVO2: +2,4 mL/kg/min (SD±2)] of 26 patients (13 per arm) would be necessary to test our hypothesis.
Detailed description
Heart failure (HF) is a highly prevalent clinical entity that predominantly affects elderly people with comorbidities. Among these, chronic kidney disease is particularly frequent, complicating disease management and worsening prognosis. Supervised training programs in patients with HF have improved functional capacity and reduced hospitalizations. However, the evidence is scarce regarding the effects of a supervised training program on patients with HF and cardiorenal syndrome. This work aims to evaluate the effect of a supervised exercise program for 12 weeks in patients with HF and cardiorenal syndrome on peak oxygen consumption (peakVO2).
This is a prospective study, blinded for the evaluator, randomized (1:1) to receive standard management alone or combined with a training program (aerobic combined with strength exercises) that will be carried out in a single center. After randomization, patients will be clinically evaluated. The primary endpoint (peakVO2) will be assessed by cardiopulmonary exercise testing combined with echocardiography (echo-CPET) at 12 weeks. Ambulatory patients with heart failure and cardiorenal syndrome and functional class NYHA II-III will be enrolled. A sample size estimation [alfa: 0.05, power: 80%, a 20% loss rate, and at least a delta change of mean peakVO2: +2,4 mL/kg/min (SD±2)] of 26 patients (13 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
- 2
- Model description
- This is a prospective study, blinded for the evaluator, randomized (1:1) to receive standard management alone or combined with a training program (aerobic combined with strength exercises) that will be carried out in a single center.
| 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 plus strenght training | Active comparator | Behavioral: Supervised aerobic plus strength trainingPatients allocated to this arm will receive the usual care plus supervised aerobic and strength training. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients diagnosed with heart failure according to 2021 ESC guidelines for Heart Failure.
- Evidence of cardiorenal syndrome, defined as coexistent very high risk chronic kidney disease (CKD) (estimated glomerular filtration rate [eGFR] \<30 ml/min/1.73m2 or eGFR 30 to 44 ml/min/1.73m2 and Urine Albumin-Creatinine Ratio [uACR] \>30 mg/g) or rapidly progressive CKD (loss of \>5 ml/min/1.73m2 in one year).
- Stable symptomatic heart failure patients (New York Heart Association functional class II-III/IV) during the last month.
- Age ≥ 18 years old.
- Willing to provide written informed consent.
Key exclusion criteria (6 listed)
- Inability to perform a valid baseline cardiopulmonary exercise test.
- Significant primary severe valve disease that is considered the main symptom driver.
- Effort angina or signs of ischemia during CPET.
- Primary cardiomyopathies.
- Cardiac transplantation.
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 plus strength trainingSupervised moderate to high-intensity interval aerobic training plus moderate to high-intensity strength training. | Behavioural | Supervised aerobic plus strenght training |
Primary outcome
Peak oxygen consumption
Time frame: The investigators will evaluate peak oxygen consumption at baseline (week 0) and at week 12.
Primary outcome: changes in peak oxygen consumption between groups at 12 weeks. Description: Peak oxigen consumption (also known as maximal functional capacity) will be evaluated using incremental and symptom-limited cardiopulmonary exercise testing on a semi-supine bicycle ergometer (coupled with stress echocardiography), beginning with a workload of 10 Watts and increasing gradually in a ramp protocol at 10-Watts increments every 1 minute. Peak oxygen consumption (PeakVO2) is defined as the highest value of VO2 during the last 20 seconds of exercise. Unit of measure of peak oxygen consumption: mL/kg/min (this is a directly reported measure from the cardiopulmonary exercise testing, not an aggregated or derived calculation).
2 secondary outcomes
Kansas City Cardiomyopathy Questionnaire
Time frame: The investigators will evaluate Kansas City Cardiomyopathy Questionnaire at baseline (week 0) and at week 12.
Chronotropic index
Time frame: The investigators will evaluate chronotropic index at baseline (week 0) and at week 12.
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 15 Oct 2024.
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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.
Gonzalo Núñez Marín, MD principal investigator
Instituto de investigación 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 plus strength training in people with Heart Failure and Cardiorenal Syndrome, 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 6 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: opening soon, as of the sponsor's last update on 15 Oct 2024. 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?
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?
Contact Patricia Fernández, PhD (961973536 ext. +34, patricia.fernandez@incliva.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak oxygen consumption (time frame: The investigators will evaluate peak oxygen consumption at baseline (week 0) and at week 12.). 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 15 Oct 2024; AzTrials last refreshed its copy on 27 Oct 2026.