Heart Failure, DiastolicWTLSSCHFNCT02911337
Weight Loss as Therapy for Heart Failure With Preserved Ejection Fraction
A study testing lifestyle modification in people with Heart Failure, Diastolic and Weight Loss, run by Medical University of South Carolina at 1 site in United States.
Trial summary
The purpose of this study is to examine the efficacy of an intensive, supervised, lifestyle modification program on symptoms and signs of heart failure as well as laboratory and echocardiographic measures of cardiac structure and function. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Heart Failure, Diastolic, Weight Loss
- What is being tested?
- lifestyle modification
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2015to 28 Dec 2018
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- BMI > 30
- Able to perform 6 minute hall walk test
- Left Ventricular ejection fraction >45%
- Diagnosis of heart failure with preserved ejection fraction (HFpEF) ; confirmation of HFpEF based on 1 major or 3 minor criteria listed below.
- Major:
- Elevated BNP >200
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- cardiogenic pulmonary edema
- Pulmonary capillary wedge pressure at rest >15 mmhg or with exercise >25 mmhg using invasive right heart pressure measurement
- Minor:
- Left atrial enlargement (volume >68 ml)
- increased left ventricular wall thickness (>1.1cm) by echocardiography
- E/e' >15
- intermediate level of BNP, 60-199
Who cannot join
- uncontrolled blood pressure
- severe chronic obstructive pulmonary disease (oxygen or steroid dependent)
- recurrent major depression. presence or history of suicide behavior, and current substantial depressive symptoms. Antidepressant drugs are allowed if the dose has been stable for 3 months
- other major psychiatric illness (schizophrenia, bipolar, dementia)
- significant hepatic dysfunction
- untreated hypothyroidism or hyperthyroidism
Show all 23Show fewer
- history of drug or alcohol abuse or dependency within the past 12 months
- acute coronary syndrome without revascularization in the past 12 months
- acute coronary syndrome with revascularization in the past 6 months
- Cerebrovascular accident or transient ischemic attack in the past 6 months
- cancer or terminal illness with life expectancy < 3 years
- history of medical noncompliance
- significant anemia (hgb <9)
- life threatening or uncontrolled arrhythmia
- hemodynamically relevant valvular heart disease
- infiltrative heart disease including cardiac amyloidosis, sarcoidosis, Fabry's disease
- genetic hypertrophic cardiomyopathy
- significant pericardial disease
- clinically relevant neuromuscular disease
- pregnant or may become pregnant in the next 6 months
- prior major organ transplant or intent to transplant ( on the transplant list)
- pacemaker dependant
- clinically significant congenital heart disease that may be cause of symptoms
Trial locations and contacts
1 site in 1 country.
United States1 site
MUSC Gazes Research Institue
Charleston, South Carolina, 29425
About this study
The purpose of this study is to examine the efficacy of an intensive, supervised, lifestyle modification program on symptoms and signs of heart failure as well as laboratory and echocardiographic measures of cardiac structure and function. This will be a 6 month trial in 50 patients with a clinical diagnosis of heart failure with preserved ejection fraction (HFpEF). Patients will be enrolled in the Medical University of South Carolina weight management 15 week lifestyle change program which will involve weekly visits that rotate among the clinical specialities (dietary, exercise and behavioral) and scheduled visits with the research Registered Nurse. Each patients baseline data will be used as the control and compared with the same measurements at the 6 month end point.
- Conditions
- Heart Failure, Diastolic, Weight Loss
- Being tested
- lifestyle modification
- Medical subject headings
- Heart Failure, Diastolic, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lifestyle modificationDietary supplement
Subjects will be given meal replacements (shakes and bars) to be consumed twice per day for 8 weeks, and then once per day for an additional 3 weeks, and then transitioned to a structured diet.
| Study group | Role | What they receive |
|---|---|---|
| Lifestyle modification | Experimental | Lifestyle modification Receives: Dietary Supplement: lifestyle modification |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in 6 minute hall walk test from baseline
Exercise capacity
Measured: 6 months
Change in symptoms measured with the Minnesota Living With Heart Failure(MLWHF) scores
Quality of life assessment specific for congestive heart failure
Measured: 6 months
Secondary outcomes (2)
Left Ventricular mass
Changes in left ventricular mass will be measured by transthoracic echocardiography
Measured: 6 months
Brain Natriuretic Peptide
Brain natriuretic peptide will be measured in serum using standard commercial assay
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2016 (estimated)
- Study startAug 2015
- Primary completion28 Dec 2018
- Study completion28 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart Failure, DiastolicStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02911337
- Sponsor's protocol ID
- WTLSSCHF
- Acronym
- WTLSSCHF
- Status last verified
- Jul 2025
- First submitted
- 23 Jul 2015
- Last updated
- 10 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
El Hajj EC, El Hajj MC, Sykes B, Lamicq M, Zile MR, Malcolm R, O'Neil PM, Litwin SE. Pragmatic Weight Management Program for Patients With Obesity and Heart Failure With Preserved Ejection Fraction. J Am Heart Assoc. 2021 Nov 2;10(21):e022930. doi: 10.1161/JAHA.121.022930. Epub 2021 Oct 29.
PubMed 34713711
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Weight Loss as Therapy for Heart Failure With Preserved Ejection Fraction
- ClinicalTrials.gov ID
- NCT02911337
- Acronym / sponsor ID
- WTLSSCHF / WTLSSCHF
- Conditions
- Heart Failure, Diastolic, Weight Loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- 28 Dec 2018 (actual)
- Study completion
- 28 Dec 2018 (actual)
- First posted
- 22 Sep 2016 (estimated)
- 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.
The purpose of this study is to examine the efficacy of an intensive, supervised, lifestyle modification program on symptoms and signs of heart failure as well as laboratory and echocardiographic measures of cardiac structure and function. This will be a 6 month trial in 50 patients with a clinical diagnosis of heart failure with preserved ejection fraction (HFpEF). Patients will be enrolled in the Medical University of South Carolina weight management 15 week lifestyle change program which will involve weekly visits that rotate among the clinical specialities (dietary, exercise and behavioral) and scheduled visits with the research Registered Nurse. Each patients baseline data will be used as the control and compared with the same measurements at the 6 month end point.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lifestyle modification | Experimental | Dietary Supplement: lifestyle modificationLifestyle modification |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- BMI > 30
- Able to perform 6 minute hall walk test
- Left Ventricular ejection fraction >45%
- Diagnosis of heart failure with preserved ejection fraction (HFpEF) ; confirmation of HFpEF based on 1 major or 3 minor criteria listed below.
- Elevated BNP >200
Key exclusion criteria (23 listed)
- uncontrolled blood pressure
- severe chronic obstructive pulmonary disease (oxygen or steroid dependent)
- recurrent major depression. presence or history of suicide behavior, and current substantial depressive symptoms. Antidepressant drugs are allowed if the dose has been stable for 3 months
- other major psychiatric illness (schizophrenia, bipolar, dementia)
- significant hepatic dysfunction
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 |
|---|---|---|
| lifestyle modificationSubjects will be given meal replacements (shakes and bars) to be consumed twice per day for 8 weeks, and then once per day for an additional 3 weeks, and then transitioned to a structured diet. | Dietary supplement | Lifestyle modification |
Primary outcome
Change in 6 minute hall walk test from baseline
Time frame: 6 months
Exercise capacity
Change in symptoms measured with the Minnesota Living With Heart Failure(MLWHF) scores
Time frame: 6 months
Quality of life assessment specific for congestive heart failure
2 secondary outcomes
Left Ventricular mass
Time frame: 6 months
Brain Natriuretic Peptide
Time frame: 6 months
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 10 Jul 2025.
- Derived from this study: PubMed 34713711El Hajj EC, El Hajj MC, Sykes B, Lamicq M, Zile MR, Malcolm R, O'Neil PM, Litwin SE. Pragmatic Weight Management Program for Patients With Obesity and Heart Failure With Preserved Ejection Fraction. J Am Heart Assoc. 2021 Nov 2;10(21):e022930. doi: 10.1161/JAHA.121.022930. Epub 2021 Oct 29.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing lifestyle modification in people with Heart Failure, Diastolic and Weight Loss, run by Medical University of South Carolina 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 13 inclusion and 23 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 10 Jul 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.
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?
Change in 6 minute hall walk test from baseline (time frame: 6 months). 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?
On the ClinicalTrials.gov record for NCT02911337, which also lists 1 linked publication.
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 10 Jul 2025.