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Heart Failure and Preserved Ejection FractionOBESE-HFpEFNCT07539766

OBESE-HFpEF: Towards Preventing Obesity Related HFpEF

An observational study of Heart Failure and Preserved Ejection Fraction and Obesity (Disorder), run by Zuyderland Medisch Centrum at 1 site in Netherlands.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Obesity, severe overweight, is a growing problem worldwide and increases the risk of heart failure, especially a type called heart failure with preserved ejection fraction (HFpEF). In HFpEF, the heart becomes stiffer. Read more about this study

Who is it for?
Ages 35 years and olderHealthy volunteers can take part
How many people
250 participants
Where
1 siteNetherlands
Study dates
1 Jan 2025to 1 Jan 2029
How long will I take part?
2 Years
Phase
Observational
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 35 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Our study population consists of patients presenting at the DOC South requesting metabolic bariatric surgery. Our predetermined sample size was set at 250 participants.

Who may be able to join

  • Age ≥ 35 years
  • Eligible for surgical treatment for obesity, according to the Dutch guideline, i.e. a BMI ≥ 40 kg/m2 or a BMI ≥ 35 kg/m2 with one or more comorbidities associated with obesity. (23)

Who cannot join

  • Inability to provide informed consent.
  • A BMI >60 kg/m2
  • Inability of undergoing metabolic bariatric surgery safely.
  • Inability to undergo the study measurement/tests.
  • Not proficient in the Dutch language
  • A medical history of a reduced LVEF at any time, history of severe cardiac valve defects or severe congenital cardiac defects.
  • A medical history of previous metabolic bariatric surgery.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Lukas Peeters, Master of Science in Medicine contact

+32479092470

luka.peeters@zuyderland.nl

Netherlands1 site, 1 recruiting

  • Zuyderland Medisch Centrum Heerlen

    Heerlen, Limburg, 6419PC

    Lukas Peeters, Master of Science in Medicine, +32479092470, luka.peeters@zuyderland.nl

    Lukas Peeters, Master of Science in Medicine

    Recruiting

Other trials in Netherlands

About this study

Official title: OBESE-HFpEF: Prevalence and Mediators of Heart Failure (Preserved Ejection Fraction) in the Dutch Obesity Clinic South - Towards Preventing Obesity Related HFpEF''

Obesity, severe overweight, is a growing problem worldwide and increases the risk of heart failure, especially a type called heart failure with preserved ejection fraction (HFpEF).

In HFpEF, the heart becomes stiffer. This makes it harder for the heart to fill with blood, which can lead to shortness of breath during physical activity.

Read more

In the Netherlands, 15% of the population has obesity. In South Limburg, this is even higher at 19%. Among people with HFpEF, obesity is much more common: about 50% of these patients have obesity.

Life expectancy in people with HFpEF is poor, and current treatment mainly focuses on reducing symptoms. Early recognition and treatment of risk factors, such as obesity, are therefore very important.

This study includes about 250 people with obesity. Using a heart ultrasound and tests of blood and fat tissue, we will look for early signs of HFpEF and study the effects of weight loss. The measurements will be repeated after 1 and 2 years.

The goal of this study is to better understand how obesity contributes to HFpEF and how weight loss affects the heart. This research may help improve future treatments for patients with HFpEF.

Read the detailed description

The study is an observational, longitudinal cohort study, with extensive phenotyping at baseline and at 1- and 2 years follow-up after Metabolic bariatric surgery. The baseline assessment corresponds to the intake phase at the obesity clinic. All patients will undergo Metabolic Bariatric Surgery and multi-disciplinary treatment focused on life style change. All patients will then be followed longitudinally with repeated assessments after 1- and 2 years follow-up.

The primary objective of this study is:

  1. To determine the prevalence of HFpEF and (pre)-HFpEF in patients with obesity requesting MBS.

Secondary objective(s):

  1. Evaluate the differences between the three study groups (HFpEF vs preHFpEF vs patients without HF) concerning pathophysiologic mediators, functional status, QoL and medical history/demographics at baseline.

II) Evaluate the prevalence of (pre-)HFpEF at 1- and 2 years after MBS, i.e. evaluating the reclassification (transition) in disease groups from baseline.

III) Evaluate changes in cardiac function and pathophysiologic mediators from baseline to 1- and 2 years after MBS.

IV) Evaluate changes in quality of life (QoL) and functional capacity measured as change in 6-minute walking test distance from baseline to 1- and 2 years after MBS.

Keywords
Obesity, Heart Failure with preserved ejection fraction, Metabolic Bariatric Surgery, Prospective
Medical subject headings
Heart Failure, Diastolic, Obesity, Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07539766
Study groupRoleWhat they receive
Patients with obesity grade 2 or higher presenting at the Dutch obesity clinic requesting MBS.Our study population consists of patients presenting at the DOC South requesting Metabolic bariatric surgery (MBS). 10-15 new patients present themselves weekly at the DOC South, from which study participants can be recruited. Our population is 35 years or older and has no previous history of a reduced ejection fraction, severe cardiac valve defects of severe congenital cardiac defects. Our population does not have a previous history of metabolic bariatric surgery.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Prevalence of HFpEF and (pre)-HFpEF in patients with obesity at baseline.

    The primary endpoint of this study is the total percentage of individuals with obesity who have (pre-)HFpEF within our study population. This will be measured by performing echocardiography, physical examination, and measuring natriuretic peptides. For the definition of HFpEF, we use the diagnostic criteria from the European HF guidelines. (12)

    1. HFpEF is defined as follows :
    • symptoms and signs of HF (table II, at least 1 typical/more specific or 2 less typical/less specific)
    • evidence of structural and/or functional cardiac abnormalities demonstrated by echocardiography (table III) and/or raised natriuretic peptides (NPs)
    • LVEF ≥50%
    1. Pre-HFpEF:
    • No symptoms or signs of HF (table II).
    • Evidence of structural and/or functional cardiac abnormalities demonstrated by echocardiography (table III) and/or raised natriuretic peptides (NPs)
    • LVEF ≥50%,
    1. Individuals with obesity who do not meet the criteria above are consequently the patients that are not as having (pre-)HFpEF.

    Measured: Baseline

Secondary outcomes (14)

  1. Delta in total percentage of (pre-)HFpEF cases after metabolic bariatric surgery at 1-and 2 years follow-up.

    Measured: 2 years

  2. Mean difference between HFpEF, pre-HFpEF and patients without HF concerning low grade inflammation (High sensitivity C-reactive protein).

    Difference in High sensitivity C-reactive protein (mg/L) at baseline

    Measured: Baseline

  3. Mean difference between HFpEF, pre-HFpEF and patients without HF concerning low grade inflammation (IL6).

    Difference in interleukin-6 (pg/ml) at baseline

    Measured: Baseline

  4. Mean difference between HFpEF, pre-HFpEF and patients without HF concerning NT-proBNP

    Difference in NT-proBNP (ng/L) at baseline.

    Measured: Baseline

  5. Mean difference between HFpEF, pre-HFpEF and patients without HF concerning antropomorphic measurements (BMI).

    Difference in BMI (Kg2/m) at baseline.

    Measured: Baseline

  6. Mean difference between HFpEF, pre-HFpEF and patients without HF concerning antropomorphic measurements (Waist-to-Height ratio).

    Difference in Waist-to-Height ratio (Waist circumference (cm) divided by height (cm)) at baseline.

    Measured: Baseline

  7. Mean difference between HFpEF, pre-HFpEF and patients without HF concerning adipocyte cell size.

    Difference in adipocyte cell size in diameter (micrometers) and cross sectional area (square micrometers) at baseline.

    Measured: Baseline

  8. Mean difference between HFpEF, pre-HFpEF and patients without HF concerning adipose tissue hyperplasia

    Difference in adipose tissue hyperplasia in total cell number and adipcyte cell density (cells/mm2) at baseline.

    Measured: Baseline

  9. Delta in low grade inflammation (High sensitivity C-reactive protein) from baseline to 1- and 2 year follow-up.

    Changes in High sensitivity C-reactive protein (mg/L), from baseline to 1- and 2 years after metabolic bariatric surgery.

    Measured: 2 years

  10. Delta in low grade inflammation (IL-6) from baseline to 1- and 2 year follow-up

    Changes in IL-6 from baseline (pg/ml), from baseline to 1- and 2 years after metabolic bariatric surgery.

    Measured: 2 years

  11. Delta in NTproBNP from baseline to 1- and 2 year follow-up.

    Changes in N-terminal brain natriuretic peptide (ng/L), from baseline to 1- and 2 years after metabolic bariatric surgery.

    Measured: 2 years

  12. Delta in functional capacity from baseline to 1- and 2 years folllow-up

    Change in the six-minute walking test distance from baseline to 1- and 2 years follow-u after metabolic bariatric surgery.

    Measured: 2 Years

  13. Change in antropomorphic measures (BMI) from baseline to 1- and 2 year follow-up

    Changes in BMI (Kg2/m), from baselin to 1- and 2 years after metabolic bariatric surgery.

    Measured: 2 years

  14. Change in antropomorphic measures (Waist-to-height ratio) from baseline to 1- and 2 year follow-up

    Changes in Waist-to-height ratio (Waist circumference (cm) divided by height (cm)), from baseline to 1-and 2 years after metabolic surgery.

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Apr 2026
  2. Study start1 Jan 2025
  3. Primary completion1 May 2028 (estimated)
  4. Study completion1 Jan 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
250 participants (estimated)
Target duration
2 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT07539766
Sponsor's protocol ID
NL-009536
Acronym
OBESE-HFpEF
Status last verified
Jan 2026
First submitted
30 Jan 2026
Last updated
20 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Vahanian A, Beyersdorf F, Praz F, Milojevic M, Baldus S, Bauersachs J, Capodanno D, Conradi L, De Bonis M, De Paulis R, Delgado V, Freemantle N, Gilard M, Haugaa KH, Jeppsson A, Juni P, Pierard L, Prendergast BD, Sadaba JR, Tribouilloy C, Wojakowski W; ESC/EACTS Scientific Document Group. 2021 ESC/EACTS Guidelines for the management of valvular heart disease. Eur Heart J. 2022 Feb 12;43(7):561-632. doi: 10.1093/eurheartj/ehab395. No abstract available.

    PubMed 34453165

  • Zain S, Shamshad T, Kabir A, Khan AA. Epicardial Adipose Tissue and Development of Atrial Fibrillation (AFIB) and Heart Failure With Preserved Ejection Fraction (HFpEF). Cureus. 2023 Sep 28;15(9):e46153. doi: 10.7759/cureus.46153. eCollection 2023 Sep.

    PubMed 37900360

  • Li C, Qin D, Hu J, Yang Y, Hu D, Yu B. Inflamed adipose tissue: A culprit underlying obesity and heart failure with preserved ejection fraction. Front Immunol. 2022 Nov 22;13:947147. doi: 10.3389/fimmu.2022.947147. eCollection 2022.

    PubMed 36483560

  • Kawai T, Autieri MV, Scalia R. Adipose tissue inflammation and metabolic dysfunction in obesity. Am J Physiol Cell Physiol. 2021 Mar 1;320(3):C375-C391. doi: 10.1152/ajpcell.00379.2020. Epub 2020 Dec 23.

    PubMed 33356944

  • Borlaug BA, Jensen MD, Kitzman DW, Lam CSP, Obokata M, Rider OJ. Obesity and heart failure with preserved ejection fraction: new insights and pathophysiological targets. Cardiovasc Res. 2023 Feb 3;118(18):3434-3450. doi: 10.1093/cvr/cvac120.

    PubMed 35880317

  • Wilding JPH, Batterham RL, Davies M, Van Gaal LF, Kandler K, Konakli K, Lingvay I, McGowan BM, Oral TK, Rosenstock J, Wadden TA, Wharton S, Yokote K, Kushner RF; STEP 1 Study Group. Weight regain and cardiometabolic effects after withdrawal of semaglutide: The STEP 1 trial extension. Diabetes Obes Metab. 2022 Aug;24(8):1553-1564. doi: 10.1111/dom.14725. Epub 2022 May 19.

    PubMed 35441470

  • Shimada YJ, Tsugawa Y, Brown DFM, Hasegawa K. Bariatric Surgery and Emergency Department Visits and Hospitalizations for Heart Failure Exacerbation: Population-Based, Self-Controlled Series. J Am Coll Cardiol. 2016 Mar 1;67(8):895-903. doi: 10.1016/j.jacc.2015.12.016.

    PubMed 26916477

  • Berger S, Meyre P, Blum S, Aeschbacher S, Ruegg M, Briel M, Conen D. Bariatric surgery among patients with heart failure: a systematic review and meta-analysis. Open Heart. 2018 Dec 9;5(2):e000910. doi: 10.1136/openhrt-2018-000910. eCollection 2018.

    PubMed 30613414

  • Courcoulas AP, Belle SH, Neiberg RH, Pierson SK, Eagleton JK, Kalarchian MA, DeLany JP, Lang W, Jakicic JM. Three-Year Outcomes of Bariatric Surgery vs Lifestyle Intervention for Type 2 Diabetes Mellitus Treatment: A Randomized Clinical Trial. JAMA Surg. 2015 Oct;150(10):931-40. doi: 10.1001/jamasurg.2015.1534.

    PubMed 26132586

  • Carroll RW, Stubbs RS, Krebs JD. Weight and Metabolic Outcomes 12 Years after Gastric Bypass. N Engl J Med. 2018 Jan 4;378(1):93. doi: 10.1056/NEJMc1714001. No abstract available.

    PubMed 29298158

  • Sepehrvand N, Alemayehu W, Dyck GJB, Dyck JRB, Anderson T, Howlett J, Paterson I, McAlister FA, Ezekowitz JA. External Validation of the H2F-PEF Model in Diagnosing Patients With Heart Failure and Preserved Ejection Fraction. Circulation. 2019 May 14;139(20):2377-2379. doi: 10.1161/CIRCULATIONAHA.118.038594. No abstract available.

    PubMed 31082301

  • McDonagh TA, Metra M, Adamo M, Gardner RS, Baumbach A, Bohm M, Burri H, Butler J, Celutkiene J, Chioncel O, Cleland JGF, Crespo-Leiro MG, Farmakis D, Gilard M, Heymans S, Hoes AW, Jaarsma T, Jankowska EA, Lainscak M, Lam CSP, Lyon AR, McMurray JJV, Mebazaa A, Mindham R, Muneretto C, Francesco Piepoli M, Price S, Rosano GMC, Ruschitzka F, Skibelund AK; ESC Scientific Document Group. 2023 Focused Update of the 2021 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure. Eur Heart J. 2023 Oct 1;44(37):3627-3639. doi: 10.1093/eurheartj/ehad195. No abstract available.

    PubMed 37622666

  • Chockalingam A. "Obesity-Years" Burden May Predict Reversibility in Heart Failure With Preserved Ejection Fraction. Front Cardiovasc Med. 2022 Feb 7;9:821829. doi: 10.3389/fcvm.2022.821829. eCollection 2022. No abstract available.

    PubMed 35198616

  • Obokata M, Reddy YNV, Pislaru SV, Melenovsky V, Borlaug BA. Evidence Supporting the Existence of a Distinct Obese Phenotype of Heart Failure With Preserved Ejection Fraction. Circulation. 2017 Jul 4;136(1):6-19. doi: 10.1161/CIRCULATIONAHA.116.026807. Epub 2017 Apr 5.

    PubMed 28381470

  • Ho JE, Lyass A, Lee DS, Vasan RS, Kannel WB, Larson MG, Levy D. Predictors of new-onset heart failure: differences in preserved versus reduced ejection fraction. Circ Heart Fail. 2013 Mar;6(2):279-86. doi: 10.1161/CIRCHEARTFAILURE.112.972828. Epub 2012 Dec 27.

    PubMed 23271790

Questions about this trial

What is this clinical trial studying?

An observational study of Heart Failure and Preserved Ejection Fraction and Obesity (Disorder), run by Zuyderland Medisch Centrum at 1 site in Netherlands.

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 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 20 Apr 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 Netherlands. 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 Lukas Peeters, Master of Science in Medicine (+32479092470, luka.peeters@zuyderland.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Prevalence of HFpEF and (pre)-HFpEF in patients with obesity at baseline. (time frame: Baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07539766, which also lists 21 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2026; AzTrials last refreshed its copy on 6 Nov 2026.

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