NCT07539766

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
33mo left

Started Jan 2025

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress34%
Jan 2025Jan 2029

Study Start

First participant enrolled

January 1, 2025

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

January 30, 2026

Completed
3 months until next milestone

First Posted

Study publicly available on registry

April 20, 2026

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2028

Expected
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2029

Last Updated

April 20, 2026

Status Verified

January 1, 2026

Enrollment Period

3.3 years

First QC Date

January 30, 2026

Last Update Submit

April 13, 2026

Conditions

Heart Failure and Preserved Ejection FractionObesity (Disorder)Heart Failure

Keywords

ObesityHeart Failure with preserved ejection fractionMetabolic Bariatric SurgeryProspective

Outcome Measures

Primary Outcomes (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% 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 Outcomes (14)

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

    2 years

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

    Baseline

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

    Baseline

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

    Baseline

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

    Baseline

  • +9 more secondary outcomes

Study Arms (1)

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.

Eligibility Criteria

Age35 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zuyderland Medisch Centrum Heerlen

Heerlen, Limburg, 6419PC, Netherlands

RECRUITING

Related Publications (21)

  • 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.

    BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    BACKGROUND

  • Chockalingam A. "Obesity-Years" Burden May Predict Reversibility in Heart Failure With Preserved Ejection Fraction. Front Cardiovasc Med 2022;9:821829.

    BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Visceral and subcutaneous adipose tissue biopsies

MeSH Terms

Conditions

Heart Failure, DiastolicObesityHeart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Sandra van Wijk, Dr.

    Zuyderland Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lukas Peeters, Master of Science in Medicine

CONTACT

+32479092470luka.peeters@zuyderland.nl

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
2 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 30, 2026

First Posted

April 20, 2026

Study Start

January 1, 2025

Primary Completion (Estimated)

May 1, 2028

Study Completion (Estimated)

January 1, 2029

Last Updated

April 20, 2026

Record last verified: 2026-01

Locations

NL(1)