HFpEF - Heart Failure With Preserved Ejection FractionPhase 2/3TEXPEFNCT07223242
Tailored Exercise Training Study Among Adults With HFpEF
A Phase 2/3 study testing Moderate-intensity continuous training (MCT), Resistance training and Weight loss in people with HFpEF - Heart Failure With Preserved Ejection Fraction and Diabetic Cardiomyopathies, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
Heart failure with preserved ejection fraction (HFpEF) is associated with a high morbidity and mortality burden. There are limited pharmacological options available for the treatment of HFpEF. Exercise intolerance (EI) is the cardinal symptom of HFpEF, which manifests as dyspnea and fatigue. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HFpEF - Heart Failure With Preserved Ejection Fraction, Diabetic Cardiomyopathies
- What is being tested?
- Moderate-intensity continuous training (MCT), Resistance training and Weight loss
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Feb 2025to 30 Dec 2026
- Phase
- Phase 2/3
- 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
- Age>= 18 yrs
- LVEF (Left Ventricular Ejection Fraction) >= 50%
- History of HFpEF or at risk of HFpEF
- HFpEF diagnosis based on:- -HF hospitalization within 12 months-
- NT-proBNP >360 pg/mL
- Risk of HFpEF based on:-
Show all 10Show fewer
- >2 risk factors (h/o diabetes, hypertension, obesity, physical inactivity by self-report)
- SPPB < 10 or VO2<60th percentile
- BMI >=28 (for randomization in phase II)
- Able to use cell phone and mobile application
Who cannot join
- Hospitalization 1 month prior to baseline visit
- History of recurrent falls
- eGFR (Estimated Glomerular Filtration Rate) <20ml/min/1.73m
- Active changes in HF therapies over 2 weeks prior to baseline visit
- Inability participate in exercise training therapy
- Inability to perform CPET (Cardiopulmonary Exercise Testing) testing
Show all 11Show fewer
- Severe left side valvular heart disease
- End stage pulmonary disease, requiring continuous supplemental oxygen
- Major surgery within 3 months of screening or major elective surgery during the duration of the study.
- Unstable weight defined by >5% change in body weight in last 30 days before first study visit.
- Pregnancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Texas Southwestern Medical Center
Dallas, Texas, 75209
Ambarish Pandey, MD, 214-645-9868, ambarish.pandey@utsouthwestern.edu
About this study
Heart failure with preserved ejection fraction (HFpEF) is associated with a high morbidity and mortality burden. There are limited pharmacological options available for the treatment of HFpEF. Exercise intolerance (EI) is the cardinal symptom of HFpEF, which manifests as dyspnea and fatigue. EI leads to functional deconditioning and reduced quality of life (QOL), both of which elevate risk of death and hospitalization in patients with HFpEF. Supervised exercised training is associated with improvements in exercise capacity and QOL in adults with HFpEF. However, supervised exercise has not been widely utilized for the treatment of HFpEF due to logistical and fiscal barriers.
This study will investigate the effects of a remote exercise training intervention on exercise capacity and skeletal muscle composition in patients with HFpEF, or those at risk for it. In addition, it will compare four different lifestyle interventions for their effects on exercise capacity.
Read the detailed description
Heart failure (HF) portends substantial morbidity, mortality, and health care costs in the United States and the prevalence of heart failure with preserved ejection fraction (HFpEF) relative to HF with reduced ejection fraction (HFrEF) has been increasing. HFpEF is associated with a high morbidity and mortality burden. There are limited pharmacological options available for the treatment of HFpEF. It is now recognized as a systemic, multi-organ, geriatric syndrome, with exercise intolerance (EI) and functional impairment as the key clinical manifestations. EI leads to functional deconditioning and reduced quality of life (QOL), both of which elevate risk of death and hospitalization in patients with HFpEF. Supervised exercised training is associated with improvements in exercise capacity and QOL in adults with HFpEF. However, supervised exercise has not been widely utilized for the treatment of HFpEF due to logistical and fiscal barriers.
This study will investigate the effects of a remote exercise training intervention on exercise capacity and skeletal muscle composition in patients with HFpEF, or those at risk for it. In addition, it will compare the effects of four different lifestyle interventions on exercise capacity.
The study will be carried out in two phases. In Phase I, 120 participants will undergo three months of home-based moderate-intensity continuous training (MCT), using tailored exercise videos on a mobile or tablet. Participants will also have weekly virtual meetings with a coach to discuss their progress. This will be followed by 3 months of no intervention, to assess the effects of detraining.
In Phase II (at the 6-month mark), 100 participants will be randomized to one of four extended training strategies for 3 months -(i) MCT alone; (ii) MCT plus resistance training; (iii) MCT plus weight loss, or (iv) MCT plus resistance training and weight loss.
The co-primary outcomes are (1) peak VO2, and (2) short physical performance battery score. In addition, participants will undergo CT chest/abdomen/pelvis at 3 months and 6 months to assess change in skeletal muscle composition with MCT
- Being tested
- Moderate-intensity continuous training (MCT), Resistance training, Weight loss
- Keywords
- Diabetic cardiomyopathy, Remote exercise training, Weight loss, Rehab
- Medical subject headings
- Diabetic Cardiomyopathies, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moderate-intensity continuous training (MCT)Behavioural
Tailored moderate-intensity exercise training video with weekly virtual meetings with a coach
Resistance trainingBehavioural
Resistance training videos assigned to patient
Weight lossDrug
Initiation/intensification of weight loss medications, such as semaglutide or tirzepatide
| Study group | Role | What they receive |
|---|---|---|
| Moderate-intensity continuous training (MCT) | Active comparator | Tailored moderate-intensity exercise training video with weekly virtual meetings with a coach Receives: Behavioral: Moderate-intensity continuous training (MCT) |
| Moderate-intensity continuous training + weight loss | Experimental | Tailored moderate-intensity exercise training videos with weekly virtual meetings with a coach + initiation/intensification of pharmacological weight loss Receives: Behavioral: Moderate-intensity continuous training (MCT); Drug: Weight loss |
| Moderate-intensity continuous training + resistance training | Experimental | Tailored moderate-intensity exercise training videos with weekly virtual meetings with a coach + tailored resistance training videos Receives: Behavioral: Moderate-intensity continuous training (MCT); Behavioral: Resistance training |
| Moderate-intensity continuous training + resistance training + weight loss | Experimental | Tailored moderate-intensity exercise training videos with weekly virtual meetings with a coach + tailored resistance training videos + initiation/intensification of pharmacological weight loss Receives: Behavioral: Moderate-intensity continuous training (MCT); Behavioral: Resistance training; Drug: Weight loss |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak Exercise Oxygen Uptake (VO2peak)
VO2peak indexed to body weight (mL/kg/min) will be the co-primary outcome for the trial. VO2peak is a gold-standard measure of aerobic exercise capacity and will be measured by maximal exercise test using a previously established ergometer protocol
Measured: Baseline, 3months, 6months, and 9months
Short Physical Performance Battery (SPPB)
SPPB will be a co-primary outcome for the trial. Score ranges from 0 to 12, with 0 indicating the worst performance and 12 indicating the best.
Measured: Baseline, 3months, 6months, and 9months
Secondary outcomes (20)
Kansas City Cardiomyopathy Questionnaire 12 (KCCQ-12)
Health-related quality of life will be assessed using the KCCQ-12 questionnaire. This is a self-administered questionnaire that assesses a patient's perception of their heart failure with regard to the psychological, physical, and socioeconomic aspects of life. Scores range from 0 to 100, where 0 indicates the worst possible health status and 100 indicates the best.
Measured: Baseline, 3months, 6months, and 9months
6 Minute Walk Distance (6MWD)
6MWD is a simple and well-validated measure of submaximal exercise capacity and does not require any exercise equipment or advanced training for technicians
Measured: Baseline, 3months, 6months, and 9months
General Quality of Life - EQ-5D-5L
Change in general health-related quality of life assessed using the EuroQol 5 Dimension 5 Level (EQ-5D-5L) instrument. The EQ-5D-5L uses a descriptive system to measure health-related quality of life across five key dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is rated on five levels of severity-ranging from no problems (Level 1) to extreme problems or inability to function (Level 5). A respondent's answers generate a five-digit health state profile that reflects their unique combination of responses (e.g., 12345), representing one of 3,125 possible health states. This descriptive system enables consistent and standardized assessment of an individual's health status.
Measured: Baseline, 3months, 6months, and 9months
Thirty Second Chair Test
The 30-second chair stand test measures lower-body strength and endurance by counting how many times a person can stand up from a chair and sit down within 30 seconds.
Measured: Baseline, 3months, 6months, and 9months
Fried Frailty Phenotype
The Fried frailty phenotype defines frailty based on five criteria-unintentional weight loss, exhaustion, weakness, slow walking speed, and low physical activity. Each criterion met adds one point to the total score. The Fried Frailty scale has a score range of 0 to 5. A score of 0 means the person is robust or not frail, a score of 1 or 2 indicates pre-frailty (intermediate risk), and a score of 3 or more means the person is considered frail.
Measured: Baseline, 3months, 6months, and 9months
Resting cardiac output
Assess with echocardiography to measure stroke volume and heart rate during rest
Measured: Baseline, 3months, 6months, and 9months
Exercise cardiac output
Assess with echocardiography to measure stroke volume and heart rate responses with graded physical stress.
Measured: Baseline, 3months, 6months, and 9months
Intramyocellular fat
Assessed with non-contrast CT scans of the chest, abdomen, and pelvis. These scans will be used to measure the radiodensity of muscle tissue, quantified in Hounsfield Units (HU). Skeletal muscle tissue is assigned a range of HU values (-29 to +150). Higher fat content lowers the overall muscle density, resulting in lower HU values
Measured: Baseline, 3months, 6months, and 9months
Intermuscular Adipose Tissue (IMAT)
Assessed with non-contrast CT scans of the chest, abdomen, and pelvis. These scans quantify intermuscular adipose tissue (IMAT) using the Hounsfield unit (HU) scale, where IMAT is classified as fat density within a range of -250 to -30 HU. The area of fat deposits is then quantified in square centimeters (cm^2)
Measured: Baseline, 3months, 6months, and 9months
Subcutaneous adiposity deposits
Assessed with non-contrast CT scans of the chest, abdomen, and pelvis. These scans quantify fat deposits using the Hounsfield unit (HU) scale, where fat is defined as a density within a range of -250 to -30 HU. The area of fat deposits is then quantified in square centimeters (cm^2)
Measured: Baseline, 3months, 6months, and 9months
Visceral Adiposity Deposits
Assessed with non-contrast CT scans of the chest, abdomen, and pelvis. These scans quantify fat deposits using the Hounsfield unit (HU) scale, where fat is defined as a density within a range of -250 to -30 HU. The area of fat deposits is then quantified in square centimeters (cm^2)
Measured: Baseline, 3months, 6months, and 9months
Pericardial Adiposity Deposits
Assessed with non-contrast CT scans of the chest, abdomen, and pelvis. These scans quantify fat deposits using the Hounsfield unit (HU) scale, where fat is defined as a density within a range of -250 to -30 HU. The area of fat deposits is then quantified in square centimeters (cm^2)
Measured: Baseline, 3months, 6months, and 9months
Lower Body Adiposity Deposits
Assessed with non-contrast CT scans of the chest, abdomen, and pelvis. These scans quantify fat deposits using the Hounsfield unit (HU) scale, where fat is defined as a density within a range of -250 to -30 HU. The area of fat deposits is then quantified in square centimeters (cm^2)
Measured: Baseline, 3months, 6months, and 9months
E/e': Ratio of early mitral inflow velocity (E) to early diastolic mitral annular velocity (e')
Exercise echocardiography to measure E/e' ratio to assess left ventricular filling pressures at rest and during graded physical stress
Measured: Baseline, 3months, 6months, and 9months
Left atrial reservoir strain
Assessed using echocardiography at rest and during graded physical stress
Measured: Baseline, 3months, 6months, and 9months
Left ventricular global longitudinal strain (LV GLS)
Assessed using echocardiography at rest and during graded physical stress
Measured: Baseline, 3months, 6months, and 9months
GAD 7 score
Change in anxiety symptoms assessed using the Generalized Anxiety Disorder-7 (GAD-7) scale. Total scores range from 0 to 21, with higher scores indicating more severe anxiety symptoms.
Measured: Baseline, 3months, 6months, and 9months
PHQ 9 score
This is a self-administered questionnaire that assesses the severity of depressive symptoms. The PHQ-9 (Patient Health Questionnaire-9) ranges from 0 to 27, with higher scores indicating more severe depressive symptoms.
Measured: Baseline, 3months, 6months, and 9months
NT-proBNP
Serum level of NT-proBNP (N-terminal pro-brain natriuretic peptide), a biomarker that reflects cardiac stress.
Measured: Baseline, 3months, 6months, and 9months
High-sensitivity troponin I
Serum high-sensitivity troponin I reflects ongoing low-grade myocardial injury and is a marker of disease severity and prognosis in chronic heart failure.
Measured: Baseline, 3months, 6months, and 9months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2025
- Study start18 Feb 2025
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HFpEF - 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized in a 1:1:1:1 fashion for phase 2
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ambarish Pandey, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07223242
- Sponsor's protocol ID
- STU-2024-0592
- Acronym
- TEXPEF
- Status last verified
- Oct 2025
- First submitted
- 6 Oct 2025
- Last updated
- 31 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tailored Exercise Training Study Among Adults With HFpEF
- ClinicalTrials.gov ID
- NCT07223242
- Acronym / sponsor ID
- TEXPEF / STU-2024-0592
- Keywords
- Diabetic cardiomyopathy, Remote exercise training, Weight loss, Rehab
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- 18 Feb 2025 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 31 Oct 2025 (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 associated with a high morbidity and mortality burden. There are limited pharmacological options available for the treatment of HFpEF. Exercise intolerance (EI) is the cardinal symptom of HFpEF, which manifests as dyspnea and fatigue. EI leads to functional deconditioning and reduced quality of life (QOL), both of which elevate risk of death and hospitalization in patients with HFpEF. Supervised exercised training is associated with improvements in exercise capacity and QOL in adults with HFpEF. However, supervised exercise has not been widely utilized for the treatment of HFpEF due to logistical and fiscal barriers.
This study will investigate the effects of a remote exercise training intervention on exercise capacity and skeletal muscle composition in patients with HFpEF, or those at risk for it. In addition, it will compare four different lifestyle interventions for their effects on exercise capacity.
Detailed description
Heart failure (HF) portends substantial morbidity, mortality, and health care costs in the United States and the prevalence of heart failure with preserved ejection fraction (HFpEF) relative to HF with reduced ejection fraction (HFrEF) has been increasing. HFpEF is associated with a high morbidity and mortality burden. There are limited pharmacological options available for the treatment of HFpEF. It is now recognized as a systemic, multi-organ, geriatric syndrome, with exercise intolerance (EI) and functional impairment as the key clinical manifestations. EI leads to functional deconditioning and reduced quality of life (QOL), both of which elevate risk of death and hospitalization in patients with HFpEF. Supervised exercised training is associated with improvements in exercise capacity and QOL in adults with HFpEF. However, supervised exercise has not been widely utilized for the treatment of HFpEF due to logistical and fiscal barriers.
This study will investigate the effects of a remote exercise training intervention on exercise capacity and skeletal muscle composition in patients with HFpEF, or those at risk for it. In addition, it will compare the effects of four different lifestyle interventions on exercise capacity.
The study will be carried out in two phases. In Phase I, 120 participants will undergo three months of home-based moderate-intensity continuous training (MCT), using tailored exercise videos on a mobile or tablet. Participants will also have weekly virtual meetings with a coach to discuss their progress. This will be followed by 3 months of no intervention, to assess the effects of detraining.
In Phase II (at the 6-month mark), 100 participants will be randomized to one of four extended training strategies for 3 months -(i) MCT alone; (ii) MCT plus resistance training; (iii) MCT plus weight loss, or (iv) MCT plus resistance training and weight loss.
The co-primary outcomes are (1) peak VO2, and (2) short physical performance battery score. In addition, participants will undergo CT chest/abdomen/pelvis at 3 months and 6 months to assess change in skeletal muscle composition with MCT
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Participants will be randomized in a 1:1:1:1 fashion for phase 2
| Arm | Type | Receives |
|---|---|---|
| Moderate-intensity continuous training (MCT) | Active comparator | Behavioral: Moderate-intensity continuous training (MCT)Tailored moderate-intensity exercise training video with weekly virtual meetings with a coach |
| Moderate-intensity continuous training + weight loss | Experimental | Behavioral: Moderate-intensity continuous training (MCT), Drug: Weight lossTailored moderate-intensity exercise training videos with weekly virtual meetings with a coach + initiation/intensification of pharmacological weight loss |
| Moderate-intensity continuous training + resistance training | Experimental | Behavioral: Moderate-intensity continuous training (MCT), Behavioral: Resistance trainingTailored moderate-intensity exercise training videos with weekly virtual meetings with a coach + tailored resistance training videos |
| Moderate-intensity continuous training + resistance training + weight loss | Experimental | Behavioral: Moderate-intensity continuous training (MCT), Behavioral: Resistance training, Drug: Weight lossTailored moderate-intensity exercise training videos with weekly virtual meetings with a coach + tailored resistance training videos + initiation/intensification of pharmacological weight loss |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age>= 18 yrs
- LVEF (Left Ventricular Ejection Fraction) >= 50%
- History of HFpEF or at risk of HFpEF
- SPPB < 10 or VO2<60th percentile
- BMI >=28 (for randomization in phase II)
Key exclusion criteria (11 listed)
- Hospitalization 1 month prior to baseline visit
- History of recurrent falls
- eGFR (Estimated Glomerular Filtration Rate) <20ml/min/1.73m
- Active changes in HF therapies over 2 weeks prior to baseline visit
- Inability participate in exercise training 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 |
|---|---|---|
| Moderate-intensity continuous training (MCT)Tailored moderate-intensity exercise training video with weekly virtual meetings with a coach | Behavioural | Moderate-intensity continuous training (MCT), Moderate-intensity continuous training + resistance training, Moderate-intensity continuous training + resistance training + weight loss, Moderate-intensity continuous training + weight loss |
| Resistance trainingResistance training videos assigned to patient | Behavioural | Moderate-intensity continuous training + resistance training, Moderate-intensity continuous training + resistance training + weight loss |
| Weight lossInitiation/intensification of weight loss medications, such as semaglutide or tirzepatide | Drug | Moderate-intensity continuous training + resistance training + weight loss, Moderate-intensity continuous training + weight loss |
Primary outcome
Peak Exercise Oxygen Uptake (VO2peak)
Time frame: Baseline, 3months, 6months, and 9months
VO2peak indexed to body weight (mL/kg/min) will be the co-primary outcome for the trial. VO2peak is a gold-standard measure of aerobic exercise capacity and will be measured by maximal exercise test using a previously established ergometer protocol
Short Physical Performance Battery (SPPB)
Time frame: Baseline, 3months, 6months, and 9months
SPPB will be a co-primary outcome for the trial. Score ranges from 0 to 12, with 0 indicating the worst performance and 12 indicating the best.
20 secondary outcomes
Kansas City Cardiomyopathy Questionnaire 12 (KCCQ-12)
Time frame: Baseline, 3months, 6months, and 9months
6 Minute Walk Distance (6MWD)
Time frame: Baseline, 3months, 6months, and 9months
General Quality of Life - EQ-5D-5L
Time frame: Baseline, 3months, 6months, and 9months
Thirty Second Chair Test
Time frame: Baseline, 3months, 6months, and 9months
Fried Frailty Phenotype
Time frame: Baseline, 3months, 6months, and 9months
Resting cardiac output
Time frame: Baseline, 3months, 6months, and 9months
Exercise cardiac output
Time frame: Baseline, 3months, 6months, and 9months
Intramyocellular fat
Time frame: Baseline, 3months, 6months, and 9months
Intermuscular Adipose Tissue (IMAT)
Time frame: Baseline, 3months, 6months, and 9months
Subcutaneous adiposity deposits
Time frame: Baseline, 3months, 6months, and 9months
Visceral Adiposity Deposits
Time frame: Baseline, 3months, 6months, and 9months
Pericardial Adiposity Deposits
Time frame: Baseline, 3months, 6months, and 9months
Lower Body Adiposity Deposits
Time frame: Baseline, 3months, 6months, and 9months
E/e': Ratio of early mitral inflow velocity (E) to early diastolic mitral annular velocity (e')
Time frame: Baseline, 3months, 6months, and 9months
Left atrial reservoir strain
Time frame: Baseline, 3months, 6months, and 9months
Left ventricular global longitudinal strain (LV GLS)
Time frame: Baseline, 3months, 6months, and 9months
GAD 7 score
Time frame: Baseline, 3months, 6months, and 9months
PHQ 9 score
Time frame: Baseline, 3months, 6months, and 9months
NT-proBNP
Time frame: Baseline, 3months, 6months, and 9months
High-sensitivity troponin I
Time frame: Baseline, 3months, 6months, and 9months
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 31 Oct 2025.
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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.
University of Texas Southwestern Medical Center
Dallas, United States
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Moderate-intensity continuous training (MCT), Resistance training and Weight loss in people with HFpEF - Heart Failure With Preserved Ejection Fraction and Diabetic Cardiomyopathies, run by University of Texas Southwestern Medical Center at 1 site in United States.
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 10 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 31 Oct 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 United States. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak Exercise Oxygen Uptake (VO2peak) (time frame: Baseline, 3months, 6months, and 9months). The study lists 2 primary outcomes in all. 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 31 Oct 2025.