HF - Heart FailureEMPOWER-HFpEFNCT07727096
Exercise-Based Cardiac Rehabilitation for Patients With Heart Failure With Preserved Ejection Fraction (EMPOWER-HFpEF)
A study testing Exercise-Based Cardiac Rehabilitation and Guideline-Directed Medical Therapy in people with HF - Heart Failure and HFpEF - Heart Failure With Preserved Ejection Fraction, run by Fundación para la Investigación del Hospital Clínico de Valencia at 1 site in Spain.
Trial summary
Heart failure with preserved ejection fraction (HFpEF) is a common condition among older adults. It is associated with frequent hospitalizations, impaired functional capacity, reduced quality of life, and high healthcare utilization. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HF - Heart Failure, HFpEF - Heart Failure With Preserved Ejection Fraction, Readmission Rates
- What is being tested?
- Exercise-Based Cardiac Rehabilitation and Guideline-Directed Medical Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 390 participants
- Where
- 1 siteSpain
- Study dates
- 1 Sep 2026to 1 Sep 2031
- 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
- Adults aged 18 years or older.
- Diagnosis of heart failure with preserved ejection fraction (HFpEF) according to current clinical guidelines, defined by: a) signs and/or symptoms of heart failure; b) left ventricular ejection fraction ≥50%; c) elevated N-terminal pro-B-type natriuretic peptide (NT-proBNP) (≥220 pg/mL); and, d) objective evidence of structural and/or functional cardiac abnormalities consistent with HFpEF.
- High-risk clinical profile, defined by at least one of the following: a) hospitalization for acute or worsening heart failure within the previous 120 days; b) outpatient worsening heart failure within the previous 120 days requiring emergency department evaluation or intensification of oral or intravenous diuretic therapy in a specialized heart failure clinic; c) recent diagnosis of symptomatic HFpEF (≤120 days) with New York Heart Association (NYHA) functional class II-III; or d) stable symptomatic HFpEF (NYHA class II-III) with at least two of the following comorbidities: hypertension, diabetes mellitus, obesity (body mass index ≥30 kg/m²), chronic kidney disease, dyslipidemia, obstructive sleep apnea, or stable coronary artery disease, together with elevated NT-proBNP (≥220 pg/mL in patients in sinus rhythm or ≥600 pg/mL in patients with atrial fibrillation).
- Clinically stable at the time of enrollment, with no requirement for intravenous therapy or major changes in heart failure treatment during the previous 2 weeks.
- Considered by the investigator to be able to participate in a structured exercise-based cardiac rehabilitation program safely.
- Able and willing to provide written informed consent before any study-specific procedures.
Who cannot join
- Inability to safely participate in a structured exercise-based cardiac rehabilitation program because of severe neurological or musculoskeletal disorders, significant cognitive impairment, or severe psychiatric illness that, in the opinion of the investigator, would interfere with study participation.
- Clinically unstable heart failure at the time of enrollment, defined by the need for intravenous therapy, recent major changes in heart failure treatment, or ongoing heart failure decompensation.
- Severe valvular heart disease considered to be the primary cause of the patient's symptoms.
- Acute coronary syndrome, unstable angina, or coronary revascularization within the previous 2 weeks.
- Uncontrolled hypertension, defined as resting systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg, or resting heart rate ≥110 beats/min despite guideline-directed medical therapy.
- Severe primary pulmonary disease predominantly limiting functional capacity, including significant pulmonary hypertension, chronic thromboembolic pulmonary disease, or severe chronic obstructive pulmonary disease.
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- Primary cardiomyopathy or known infiltrative heart disease.
- Severe non-cardiac comorbidity associated with an estimated life expectancy of less than 1 year, in the opinion of the investigator.
- Inability to provide written informed consent or to comply with study procedures and follow-up requirements.
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
INCLIVA
Valencia, 46010
Patricia Fernández, PhD, 96 162 89 18, patricia.fernandez@incliva.es
About this study
Official title: Effects of a Supervised Exercise Training Program on Clinical Outcomes, Functional Capacity, and Quality of Life in Patients With Heart Failure With Preserved Ejection Fraction (EMPOWER-HFpEF)
Heart failure with preserved ejection fraction (HFpEF) is a common condition among older adults. It is associated with frequent hospitalizations, impaired functional capacity, reduced quality of life, and high healthcare utilization. Despite recent advances in pharmacological therapy, many patients continue to experience recurrent clinical deterioration and functional decline. Exercise-based cardiac rehabilitation has demonstrated benefits in improving physical performance and quality of life. Still, its effect on long-term clinical outcomes in patients with high-risk HFpEF has not been established.
The EMPOWER-HFpEF study is a multicenter, randomized, controlled trial designed to evaluate whether an early, individualized, multimodal exercise-based cardiac rehabilitation program improves clinical outcomes compared with usual care in patients with HFpEF. Eligible participants will be randomly assigned in a 1:1 ratio to receive either usual care alone or usual care plus a structured 12-month exercise-based cardiac rehabilitation program. The intervention includes an initial 6-month supervised phase, followed by a 6-month hybrid phase combining supervised sessions with structured home- or community-based exercise to promote long-term adherence and maintenance of physical activity.
The primary objective is to determine whether this rehabilitation strategy reduces adverse clinical outcomes, including all-cause mortality, heart failure hospitalizations, all-cause hospitalizations, and outpatient heart failure decompensation, while improving functional capacity and health-related quality of life over 12 months. The results of this study will provide evidence on the effectiveness of a long-term multimodal exercise-based cardiac rehabilitation program as part of the comprehensive management of patients with HFpEF.
Read the detailed description
Heart failure with preserved ejection fraction (HFpEF) accounts for more than half of all heart failure cases and is associated with a high burden of recurrent hospitalizations, impaired functional capacity, and reduced health-related quality of life. Despite advances in guideline-directed medical therapy, many patients continue to experience recurrent clinical events and progressive functional decline. Exercise-based cardiac rehabilitation has demonstrated consistent benefits on exercise capacity and quality of life in patients with heart failure; however, robust evidence regarding its impact on long-term clinical outcomes in patients with HFpEF remains limited, particularly in high-risk populations.
EMPOWER-HFpEF is a multicenter, prospective, randomized, controlled clinical trial designed to evaluate the effectiveness of an early, individualized, multimodal exercise-based cardiac rehabilitation program in patients with high-risk HFpEF. Eligible participants will be randomly assigned in a 1:1 ratio to receive either guideline-directed medical therapy alone or guideline-directed medical therapy plus a structured exercise-based cardiac rehabilitation program. The intervention will be delivered over 12 months and consists of an initial 6-month supervised phase, followed by a 6-month hybrid phase that combines supervised and home-based exercise, with the to promote long-term adherence and maintenance of physical activity.
Participants will be followed for 12 months. The study is designed to determine whether this rehabilitation strategy improves clinically relevant outcomes while preserving functional status and health-related quality of life. The results are expected to provide evidence to support the integration of long-term exercise-based cardiac rehabilitation into the routine management of patients with HFpEF.
- Conditions
- HF - Heart Failure, HFpEF - Heart Failure With Preserved Ejection Fraction, Readmission Rates, Exercise Training, Cardiac Rehab
- Being tested
- Exercise-Based Cardiac Rehabilitation, Guideline-Directed Medical Therapy
- Keywords
- Heart Failure with Preserved Ejection Fraction, Cardiac Rehabilitation, Quality of Life, Readmission
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise-Based Cardiac RehabilitationBehavioural
A structured, individualised, multimodal exercise-based cardiac rehabilitation program delivered over 12 months. The intervention includes aerobic exercise, resistance training, inspiratory muscle training, and lifestyle counselling. It consists of an initial 6-month supervised phase, followed by a 6-month hybrid phase that combines supervised and home-based exercise to promote long-term adherence and maintenance of physical activity.
Guideline-Directed Medical TherapyOther
Participants receive guideline-directed medical therapy according to current heart failure guidelines, regular follow-up in the heart failure clinic, lifestyle education, and individualized recommendations to maintain regular physical activity as part of routine clinical care.
| Study group | Role | What they receive |
|---|---|---|
| Guideline-Directed Medical Therapy | Active comparator | Participants receive guideline-directed medical therapy, regular follow-up in the heart failure clinic, lifestyle education, and individualized recommendations for home-based physical activity, in accordance with current clinical practice. Receives: Other: Guideline-Directed Medical Therapy |
| Exercise-Based Cardiac Rehabilitation | Experimental | Participants receive guideline-directed medical therapy plus a structured 12-month exercise-based cardiac rehabilitation program consisting of a 6-month supervised phase followed by a 6-month hybrid supervised and home-based phase. Receives: Behavioral: Exercise-Based Cardiac Rehabilitation; Other: Guideline-Directed Medical Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hierarchical composite clinical outcome (win ratio)
Comparison between treatment groups using a hierarchical composite endpoint analyzed according to the win ratio method. The hierarchical endpoint includes, in order of priority, all-cause mortality, heart failure hospitalization, all-cause hospitalization, outpatient heart failure decompensation without hospitalization, days alive and out of hospital, change in physical function assessed by the Short Physical Performance Battery (SPPB; total score range 0-12, with higher scores indicating better physical function), and change in health-related quality of life assessed by the Kansas City Cardiomyopathy Questionnaire Overall Summary Score (KCCQ-OSS; score range 0-100, with higher scores indicating better health status).
Measured: 12 months
Secondary outcomes (5)
All-Cause Mortality
Occurrence of death from any cause.
Measured: 12 months
Heart Failure Hospitalization or Outpatient Heart Failure Decompensation
Occurrence of hospitalization for worsening heart failure or outpatient heart failure decompensation not requiring hospitalization.
Measured: 12 months
All-Cause Hospitalization
Occurrence of hospitalization for any cause.
Measured: 12 months
Health-Related Quality of Life
Change from baseline in health-related quality of life assessed using the Kansas City Cardiomyopathy Questionnaire Overall Summary Score (KCCQ-OSS). Scores range from 0 to 100, with higher scores indicating better health status.
Measured: Baseline and 12 months
Physical Function
Change from baseline in physical function assessed using the Short Physical Performance Battery (SPPB). The SPPB total score ranges from 0 to 12 points, with higher scores indicating better lower extremity physical performance and functional status.
Measured: Baseline and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2026
- Study start1 Sep 2026 (estimated)
- Primary completion1 Sep 2031 (estimated)
- Study completion1 Sep 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HF - 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 390 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundación para la Investigación del Hospital Clínico de Valencia
- Sponsor type
- University, hospital or other
- Collaborators
- Generalitat Valenciana
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07727096
- Sponsor's protocol ID
- EMPOWER-HFpEF
- Acronym
- EMPOWER-HFpEF
- Status last verified
- Jul 2026
- First submitted
- 17 Jul 2026
- Last updated
- 27 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data relevant to the published study findings will be considered for sharing following an appropriate request, subject to applicable institutional policies and ethical and legal requirements.
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Supervised Exercise Training Program on Clinical Outcomes, Functional Capacity, and Quality of Life in Patients With Heart Failure With Preserved Ejection Fraction (EMPOWER-HFpEF)
- ClinicalTrials.gov ID
- NCT07727096
- Acronym / sponsor ID
- EMPOWER-HFpEF / EMPOWER-HFpEF
- Conditions
- HF - Heart Failure, HFpEF - Heart Failure With Preserved Ejection Fraction, Readmission Rates, Exercise Training, Cardiac Rehab
- Keywords
- Heart Failure with Preserved Ejection Fraction, Cardiac Rehabilitation, Quality of Life, Readmission
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 390 participants (estimated)
- Lead sponsor
- Fundación para la Investigación del Hospital Clínico de ValenciaUniversity, hospital or other
- Collaborators
- Generalitat Valenciana
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 1 Sep 2031 (estimated)
- Study completion
- 1 Sep 2031 (estimated)
- First posted
- 27 Jul 2026 (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.
Heart failure with preserved ejection fraction (HFpEF) is a common condition among older adults. It is associated with frequent hospitalizations, impaired functional capacity, reduced quality of life, and high healthcare utilization. Despite recent advances in pharmacological therapy, many patients continue to experience recurrent clinical deterioration and functional decline. Exercise-based cardiac rehabilitation has demonstrated benefits in improving physical performance and quality of life. Still, its effect on long-term clinical outcomes in patients with high-risk HFpEF has not been established.
The EMPOWER-HFpEF study is a multicenter, randomized, controlled trial designed to evaluate whether an early, individualized, multimodal exercise-based cardiac rehabilitation program improves clinical outcomes compared with usual care in patients with HFpEF. Eligible participants will be randomly assigned in a 1:1 ratio to receive either usual care alone or usual care plus a structured 12-month exercise-based cardiac rehabilitation program. The intervention includes an initial 6-month supervised phase, followed by a 6-month hybrid phase combining supervised sessions with structured home- or community-based exercise to promote long-term adherence and maintenance of physical activity.
The primary objective is to determine whether this rehabilitation strategy reduces adverse clinical outcomes, including all-cause mortality, heart failure hospitalizations, all-cause hospitalizations, and outpatient heart failure decompensation, while improving functional capacity and health-related quality of life over 12 months. The results of this study will provide evidence on the effectiveness of a long-term multimodal exercise-based cardiac rehabilitation program as part of the comprehensive management of patients with HFpEF.
Detailed description
Heart failure with preserved ejection fraction (HFpEF) accounts for more than half of all heart failure cases and is associated with a high burden of recurrent hospitalizations, impaired functional capacity, and reduced health-related quality of life. Despite advances in guideline-directed medical therapy, many patients continue to experience recurrent clinical events and progressive functional decline. Exercise-based cardiac rehabilitation has demonstrated consistent benefits on exercise capacity and quality of life in patients with heart failure; however, robust evidence regarding its impact on long-term clinical outcomes in patients with HFpEF remains limited, particularly in high-risk populations.
EMPOWER-HFpEF is a multicenter, prospective, randomized, controlled clinical trial designed to evaluate the effectiveness of an early, individualized, multimodal exercise-based cardiac rehabilitation program in patients with high-risk HFpEF. Eligible participants will be randomly assigned in a 1:1 ratio to receive either guideline-directed medical therapy alone or guideline-directed medical therapy plus a structured exercise-based cardiac rehabilitation program. The intervention will be delivered over 12 months and consists of an initial 6-month supervised phase, followed by a 6-month hybrid phase that combines supervised and home-based exercise, with the to promote long-term adherence and maintenance of physical activity.
Participants will be followed for 12 months. The study is designed to determine whether this rehabilitation strategy improves clinically relevant outcomes while preserving functional status and health-related quality of life. The results are expected to provide evidence to support the integration of long-term exercise-based cardiac rehabilitation into the routine management of patients with HFpEF.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Guideline-Directed Medical Therapy | Active comparator | Other: Guideline-Directed Medical TherapyParticipants receive guideline-directed medical therapy, regular follow-up in the heart failure clinic, lifestyle education, and individualized recommendations for home-based physical activity, in accordance with current clinical practice. |
| Exercise-Based Cardiac Rehabilitation | Experimental | Behavioral: Exercise-Based Cardiac Rehabilitation, Other: Guideline-Directed Medical TherapyParticipants receive guideline-directed medical therapy plus a structured 12-month exercise-based cardiac rehabilitation program consisting of a 6-month supervised phase followed by a 6-month hybrid supervised and home-based phase. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adults aged 18 years or older.
- Diagnosis of heart failure with preserved ejection fraction (HFpEF) according to current clinical guidelines, defined by: a) signs and/or symptoms of heart failure; b) left ventricular ejection fraction ≥50%; c) elevated N-terminal pro-B-type natriuretic peptide (NT-proBNP) (≥220 pg/mL); and, d) objective evidence of structural and/or functional cardiac abnormalities consistent with HFpEF.
- High-risk clinical profile, defined by at least one of the following: a) hospitalization for acute or worsening heart failure within the previous 120 days; b) outpatient worsening heart failure within the previous 120 days requiring emergency department evaluation or intensification of oral or intravenous diuretic therapy in a specialized heart failure clinic; c) recent diagnosis of symptomatic HFpEF (≤120 days) with New York Heart Association (NYHA) functional class II-III; or d) stable symptomatic HFpEF (NYHA class II-III) with at least two of the following comorbidities: hypertension, diabetes mellitus, obesity (body mass index ≥30 kg/m²), chronic kidney disease, dyslipidemia, obstructive sleep apnea, or stable coronary artery disease, together with elevated NT-proBNP (≥220 pg/mL in patients in sinus rhythm or ≥600 pg/mL in patients with atrial fibrillation).
- Clinically stable at the time of enrollment, with no requirement for intravenous therapy or major changes in heart failure treatment during the previous 2 weeks.
- Considered by the investigator to be able to participate in a structured exercise-based cardiac rehabilitation program safely.
Key exclusion criteria (9 listed)
- Inability to safely participate in a structured exercise-based cardiac rehabilitation program because of severe neurological or musculoskeletal disorders, significant cognitive impairment, or severe psychiatric illness that, in the opinion of the investigator, would interfere with study participation.
- Clinically unstable heart failure at the time of enrollment, defined by the need for intravenous therapy, recent major changes in heart failure treatment, or ongoing heart failure decompensation.
- Severe valvular heart disease considered to be the primary cause of the patient's symptoms.
- Acute coronary syndrome, unstable angina, or coronary revascularization within the previous 2 weeks.
- Uncontrolled hypertension, defined as resting systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg, or resting heart rate ≥110 beats/min despite guideline-directed medical therapy.
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-Based Cardiac RehabilitationA structured, individualised, multimodal exercise-based cardiac rehabilitation program delivered over 12 months. The intervention includes aerobic exercise, resistance training, inspiratory muscle training, and lifestyle counselling. It consists of an initial 6-month supervised phase, followed by a 6-month hybrid phase that combines supervised and home-based exercise to promote long-term adherence and maintenance of physical activity. | Behavioural | Exercise-Based Cardiac Rehabilitation |
| Guideline-Directed Medical TherapyParticipants receive guideline-directed medical therapy according to current heart failure guidelines, regular follow-up in the heart failure clinic, lifestyle education, and individualized recommendations to maintain regular physical activity as part of routine clinical care. | Other | Exercise-Based Cardiac Rehabilitation, Guideline-Directed Medical Therapy |
Primary outcome
Hierarchical composite clinical outcome (win ratio)
Time frame: 12 months
Comparison between treatment groups using a hierarchical composite endpoint analyzed according to the win ratio method. The hierarchical endpoint includes, in order of priority, all-cause mortality, heart failure hospitalization, all-cause hospitalization, outpatient heart failure decompensation without hospitalization, days alive and out of hospital, change in physical function assessed by the Short Physical Performance Battery (SPPB; total score range 0-12, with higher scores indicating better physical function), and change in health-related quality of life assessed by the Kansas City Cardiomyopathy Questionnaire Overall Summary Score (KCCQ-OSS; score range 0-100, with higher scores indicating better health status).
5 secondary outcomes
All-Cause Mortality
Time frame: 12 months
Heart Failure Hospitalization or Outpatient Heart Failure Decompensation
Time frame: 12 months
All-Cause Hospitalization
Time frame: 12 months
Health-Related Quality of Life
Time frame: Baseline and 12 months
Physical Function
Time frame: Baseline and 12 months
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 27 Jul 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data relevant to the published study findings will be considered for sharing following an appropriate request, subject to applicable institutional policies and ethical and legal requirements.
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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.
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-Based Cardiac Rehabilitation and Guideline-Directed Medical Therapy in people with HF - Heart Failure and HFpEF - Heart Failure With Preserved Ejection Fraction, 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 6 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: opening soon, as of the sponsor's last update on 27 Jul 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 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 Saiz, PhD (96 162 89 18, patricia.fernandez@incliva.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hierarchical composite clinical outcome (win ratio) (time frame: 12 months). 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 27 Jul 2026; AzTrials last refreshed its copy on 26 Oct 2026.