OBESE-HFpEF: Towards Preventing Obesity Related HFpEF (OBESE-HFpEF)

April 13, 2026 updated by: Zuyderland Medisch Centrum

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.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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:

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

Secondary objective(s):

I) 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
250

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Netherlands
    • Limburg
      • Heerlen, Limburg, Netherlands, 6419PC
        • Recruiting
        • Zuyderland Medisch Centrum Heerlen
        • Contact:
        • Sub-Investigator:
          • Lukas Peeters, Master of Science in Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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 the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Prevalence of HFpEF and (pre)-HFpEF in patients with obesity at baseline.
Time Frame: 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%

  2. 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%,
  3. Individuals with obesity who do not meet the criteria above are consequently the patients that are not as having (pre-)HFpEF.
Baseline

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Delta in total percentage of (pre-)HFpEF cases after metabolic bariatric surgery at 1-and 2 years follow-up.
Time Frame: 2 years
2 years
Mean difference between HFpEF, pre-HFpEF and patients without HF concerning low grade inflammation (High sensitivity C-reactive protein).
Time Frame: Baseline
Difference in High sensitivity C-reactive protein (mg/L) at baseline
Baseline
Mean difference between HFpEF, pre-HFpEF and patients without HF concerning low grade inflammation (IL6).
Time Frame: Baseline
Difference in interleukin-6 (pg/ml) at baseline
Baseline
Mean difference between HFpEF, pre-HFpEF and patients without HF concerning NT-proBNP
Time Frame: Baseline
Difference in NT-proBNP (ng/L) at baseline.
Baseline
Mean difference between HFpEF, pre-HFpEF and patients without HF concerning antropomorphic measurements (BMI).
Time Frame: Baseline
Difference in BMI (Kg2/m) at baseline.
Baseline
Mean difference between HFpEF, pre-HFpEF and patients without HF concerning antropomorphic measurements (Waist-to-Height ratio).
Time Frame: Baseline
Difference in Waist-to-Height ratio (Waist circumference (cm) divided by height (cm)) at baseline.
Baseline
Mean difference between HFpEF, pre-HFpEF and patients without HF concerning adipocyte cell size.
Time Frame: Baseline
Difference in adipocyte cell size in diameter (micrometers) and cross sectional area (square micrometers) at baseline.
Baseline
Mean difference between HFpEF, pre-HFpEF and patients without HF concerning adipose tissue hyperplasia
Time Frame: Baseline
Difference in adipose tissue hyperplasia in total cell number and adipcyte cell density (cells/mm2) at baseline.
Baseline
Delta in low grade inflammation (High sensitivity C-reactive protein) from baseline to 1- and 2 year follow-up.
Time Frame: 2 years
Changes in High sensitivity C-reactive protein (mg/L), from baseline to 1- and 2 years after metabolic bariatric surgery.
2 years
Delta in low grade inflammation (IL-6) from baseline to 1- and 2 year follow-up
Time Frame: 2 years
Changes in IL-6 from baseline (pg/ml), from baseline to 1- and 2 years after metabolic bariatric surgery.
2 years
Delta in NTproBNP from baseline to 1- and 2 year follow-up.
Time Frame: 2 years
Changes in N-terminal brain natriuretic peptide (ng/L), from baseline to 1- and 2 years after metabolic bariatric surgery.
2 years
Delta in functional capacity from baseline to 1- and 2 years folllow-up
Time Frame: 2 Years
Change in the six-minute walking test distance from baseline to 1- and 2 years follow-u after metabolic bariatric surgery.
2 Years
Change in antropomorphic measures (BMI) from baseline to 1- and 2 year follow-up
Time Frame: 2 years
Changes in BMI (Kg2/m), from baselin to 1- and 2 years after metabolic bariatric surgery.
2 years
Change in antropomorphic measures (Waist-to-height ratio) from baseline to 1- and 2 year follow-up
Time Frame: 2 years
Changes in Waist-to-height ratio (Waist circumference (cm) divided by height (cm)), from baseline to 1-and 2 years after metabolic surgery.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Zuyderland Medisch Centrum

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Sandra van Wijk, Dr., Zuyderland Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • Vahanian A, Beyersdorf F, Praz F, Milojevic M, Baldus S, Bauersachs J, et al. 2021 ESC/EACTS Guidelines for the management of valvular heart disease. Eur Heart J 2022 -02-12;43(7):561-632.
  • 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 -09;15(9):e46153.
  • 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 -11-22;13.
  • Kawai T, Autieri MV, Scalia R. Adipose tissue inflammation and metabolic dysfunction in obesity. American Journal of Physiology-Cell Physiology 2021 -03-01;320(3):C375.
  • 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 -02-03;118(18):3434-3450.
  • Wilding JPH, Batterham RL, Davies M, Van Gaal LF, Kandler K, Konakli K, et al. Weight regain and cardiometabolic effects after withdrawal of semaglutide: The STEP 1 trial extension. Diabetes Obes Metab 2022 -08;24(8):1553-1564.
  • 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 -03-01;67(8):895-903.
  • Berger S, Meyre P, Blum S, Aeschbacher S, Ruegg M, Briel M, et al. Bariatric surgery among patients with heart failure: a systematic review and meta-analysis. Open Heart 2018;5(2):e000910.
  • Courcoulas AP, Belle SH, Neiberg RH, Pierson SK, Eagleton JK, Kalarchian MA, et al. Three-Year Outcomes of Bariatric Surgery vs Lifestyle Intervention for Type 2 Diabetes Mellitus Treatment: A Randomized Clinical Trial. JAMA Surg 2015 -10;150(10):931-940.
  • Carroll RW, Stubbs RS, Krebs JD. Weight and Metabolic Outcomes 12 Years after Gastric Bypass. N Engl J Med 2018 -01-04;378(1):93.
  • Sepehrvand N, Alemayehu W, Dyck GJB, Dyck JRB, Anderson T, Howlett J, et al. External Validation of the H2F-PEF Model in Diagnosing Patients With Heart Failure and Preserved Ejection Fraction. Circulation 2019 -05-14;139(20):2377-2379.
  • McDonagh TA, Metra M, Adamo M, Gardner RS, Baumbach A, Böhm M, et al. 2023 Focused Update of the 2021 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure. Eur Heart J 2023 -10-01;44(37):3627-3639.
  • Chockalingam A. "Obesity-Years" Burden May Predict Reversibility in Heart Failure With Preserved Ejection Fraction. Front Cardiovasc Med 2022;9:821829.
  • 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 -07-04;136(1):6-19.
  • Ho JE, Lyass A, Lee DS, Vasan RS, Kannel WB, Larson MG, et al. Predictors of new-onset heart failure: differences in preserved versus reduced ejection fraction. Circ Heart Fail 2013 -03;6(2):279-286.
  • Tromp J, Claggett BL, Liu J, Jackson AM, Jhund PS, Køber L, et al. Global Differences in Heart Failure With Preserved Ejection Fraction: The PARAGON-HF Trial. Circ Heart Fail 2021 -04;14(4):e007901.
  • 5.Kenchaiah S, Evans JC, Levy D, Wilson PWF, Benjamin EJ, Larson MG, et al. Obesity and the Risk of Heart Failure. New England Journal of Medicine 2002 August 1;347(5):305-313.
  • 4.Kosiborod MN, Abildstrøm SZ, Borlaug BA, Butler J, Rasmussen S, Davies M, et al. Semaglutide in Patients with Heart Failure with Preserved Ejection Fraction and Obesity. New England Journal of Medicine 2023 September 20;389(12):1069-1084.
  • 3.van Dalen BM, Chin JF, Motiram PA, Hendrix A, Emans ME, Brugts JJ, et al. Challenges in the diagnosis of heart failure with preserved ejection fraction in individuals with obesity. Cardiovasc Diabetol 2025 -02-07;24(1):71.
  • 2.Snelder SM, de Groot-de Laat LE, Biter LU, Castro Cabezas M, Pouw N, Birnie E, et al. Subclinical cardiac dysfunction in obesity patients is linked to autonomic dysfunction: findings from the CARDIOBESE study. ESC Heart Fail 2020 -12;7(6):3726-3737.
  • 1.Kosyakovsky LB, Liu EE, Wang JK, Myers L, Parekh JK, Knauss H, et al. Uncovering Unrecognized Heart Failure With Preserved Ejection Fraction Among Individuals With Obesity and Dyspnea. Circ Heart Fail 2024 -05;17(5):e011366.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 30, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 13, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 20, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 20, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 13, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NL-009536

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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