HIDRAdenitis Suppurativa and HEART Disease

NCT05989945 | Active Not Recruiting DMC

• 1 other identifier: HIDRA-HEART
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

In a prospective observational cohort study (n = 250) the investigators aim to assess the correlation between cardiac biomarkers, advanced echocardiography and HS severity and determine whether these are prognostic markers of heart disease in patients suffering from hidradenitis suppurativa (HS).

Conditions

Hidradenitis; Hidradenitis Suppurativa; Hidradenitis Suppurativa, Familial; Left Ventricular Dysfunction; Myocardial Infarction; Myocardial Ischemia; Heart Failure; Stroke; Heart Diseases; Heart Failure, Systolic; Heart Failure, Diastolic

Keywords

Hidradenitis suppurativa; Echocardiography; Advanced echocardiography; Biomarkers; Cardiovascular disease; Cardiovascular mortality; Mortality

Outcome Measures

Primary Outcomes (4)

• Cardiovascular mortality

  2, 5 and 10 year follow-up

• Myocardial infarction

  2, 5 and 10 year follow-up

• Coronary revascularization (percutaneous coronary intervention/coronary artery bypass graft)

  2, 5 and 10 year follow-up

• Heart failure

  2, 5 and 10 year follow-up

Secondary Outcomes (4)

• All-cause mortality

  2, 5 and 10 year follow-up

• Stroke

  2, 5 and 10 year follow-up

• Admission with cardiac heart failure

  2, 5 and 10 year follow-up

• Admission with stroke

  2, 5 and 10 year follow-up

Study Arms (2)

Hidradenitis suppurativa patients

HS patients will be recruited prospectively from the Outpatient Clinic, Department of Dermato-Allergology, Herlev and Gentofte University Hospital, Denmark and the Outpatient Clinic, Department of Dermato-Allergology, Bispebjerg and Frederiksberg Hospital, Denmark. In order to approximate a random sample as accurate as possible including patients with mild HS, the project group will issue a general invitation to participate in the study through appropriate channels such as the Patientforeningen HS Danmark's newsletter and collaborating private dermatologists.

Control group

The control group will consist of a retrospective random sample of around 1.000 patients from the general population examined in the 4th and 5th Copenhagen City Heart Study, 2001-2003 and 2011-2014 (ClinicalTrials.gov identifier NCT02993172, I-Suite no. 03741, National Committee on Health Research Ethics approval HEH-2015-045). Existing data from the Copenhagen City Heart Study will be transferred to the current study and will include personal identification number from the Central Office of Civil Registration, echocardiographic assessments, electrocardiograms as well as health related data (health conditions including symptoms, risk factors for cardiovascular disease, medication, prior clinical and/or paraclinical assessments including blood test results and procedures relevant to psoriasis and potential heart disease).

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

HS patients will be recruited prospectively from the Outpatient Clinic, Department of Dermato-Allergology, Herlev and Gentofte University Hospital, Denmark and the Outpatient Clinic, Department of Dermato-Allergology, Bispebjerg and Frederiksberg Hospital, Denmark. In order to approximate a random sample as accurate as possible including patients with mild HS, the project group will issue a general invitation to participate in the study through appropriate channels such as the Patientforeningen HS Danmark's newsletter and collaborating private dermatologists.

You may qualify if:

• Age ≥ 18 years
• Diagnosis of HS

You may not qualify if:

• Patients unable to cooperate to the study and/or study examinations
• Patients unable to understand and sign informed consent

Sponsors & Collaborators

• Herlev and Gentofte Hospital: lead

Study Sites (1)

Department of Cardiology, Herlev and Gentofte University Hospital, University of Copenhagen

Hellerup, Copenhagen, 2900, Denmark

Location

Related Publications (13)

• Gimbrone MA Jr, Garcia-Cardena G. Endothelial Cell Dysfunction and the Pathobiology of Atherosclerosis. Circ Res. 2016 Feb 19;118(4):620-36. doi: 10.1161/CIRCRESAHA.115.306301.

  PMID: 26892962 BACKGROUND

• Hojman L, Karsulovic C. Cardiovascular Disease-Associated Skin Conditions. Vasc Health Risk Manag. 2022 Feb 16;18:43-53. doi: 10.2147/VHRM.S343319. eCollection 2022.

  PMID: 35210782 BACKGROUND

• Sabat R, Jemec GBE, Matusiak L, Kimball AB, Prens E, Wolk K. Hidradenitis suppurativa. Nat Rev Dis Primers. 2020 Mar 12;6(1):18. doi: 10.1038/s41572-020-0149-1.

  PMID: 32165620 BACKGROUND

• Vinkel C, Thomsen SF. Risk factors for cardiovascular disease in patients with hidradenitis suppurativa. J Eur Acad Dermatol Venereol. 2017 Sep;31(9):e411-e413. doi: 10.1111/jdv.14225. Epub 2017 Apr 10. No abstract available.

  PMID: 28300335 BACKGROUND

• Egeberg A, Gislason GH, Hansen PR. Risk of Major Adverse Cardiovascular Events and All-Cause Mortality in Patients With Hidradenitis Suppurativa. JAMA Dermatol. 2016 Apr;152(4):429-34. doi: 10.1001/jamadermatol.2015.6264.

  PMID: 26885728 BACKGROUND

• Gonzalez I, Pascual JC, Corona D, Hispan P, Betlloch I. European Heart Systemic Coronary Risk Evaluation may underestimate cardiovascular risk after assessing cardiovascular disease with carotid ultrasound in hidradenitis suppurativa. Br J Dermatol. 2018 Jan;178(1):e22-e23. doi: 10.1111/bjd.15776. Epub 2017 Nov 30. No abstract available.

  PMID: 28667744 BACKGROUND

• Biering-Sorensen T, Mogelvang R, Pedersen S, Schnohr P, Sogaard P, Jensen JS. Usefulness of the myocardial performance index determined by tissue Doppler imaging m-mode for predicting mortality in the general population. Am J Cardiol. 2011 Feb 1;107(3):478-83. doi: 10.1016/j.amjcard.2010.09.044.

  PMID: 21257018 BACKGROUND

• Mogelvang R, Sogaard P, Pedersen SA, Olsen NT, Marott JL, Schnohr P, Goetze JP, Jensen JS. Cardiac dysfunction assessed by echocardiographic tissue Doppler imaging is an independent predictor of mortality in the general population. Circulation. 2009 May 26;119(20):2679-85. doi: 10.1161/CIRCULATIONAHA.108.793471. Epub 2009 May 11.

  PMID: 19433761 BACKGROUND

• Mogelvang R, Sogaard P, Pedersen SA, Olsen NT, Schnohr P, Jensen JS. Tissue Doppler echocardiography in persons with hypertension, diabetes, or ischaemic heart disease: the Copenhagen City Heart Study. Eur Heart J. 2009 Mar;30(6):731-9. doi: 10.1093/eurheartj/ehn596. Epub 2009 Jan 27.

  PMID: 19176536 BACKGROUND

• Garg A, Kirby JS, Lavian J, Lin G, Strunk A. Sex- and Age-Adjusted Population Analysis of Prevalence Estimates for Hidradenitis Suppurativa in the United States. JAMA Dermatol. 2017 Aug 1;153(8):760-764. doi: 10.1001/jamadermatol.2017.0201.

  PMID: 28492923 BACKGROUND

• Ingram JR, Hadjieconomou S, Piguet V. Development of core outcome sets in hidradenitis suppurativa: systematic review of outcome measure instruments to inform the process. Br J Dermatol. 2016 Aug;175(2):263-72. doi: 10.1111/bjd.14475. Epub 2016 May 2.

  PMID: 26873867 BACKGROUND

• Alotaibi HM. Incidence, Risk Factors, and Prognosis of Hidradenitis Suppurativa Across the Globe: Insights from the Literature. Clin Cosmet Investig Dermatol. 2023 Mar 2;16:545-552. doi: 10.2147/CCID.S402453. eCollection 2023.

  PMID: 36891064 BACKGROUND

• Joseph Bailey AM, Oi-Yee Li H, Tan MG, Kirchhof MG. Hidradenitis suppurativa and major adverse cardiac events: A systematic review and meta-analysis. J Am Acad Dermatol. 2021 Mar;84(3):844-848. doi: 10.1016/j.jaad.2020.10.005. Epub 2020 Oct 8. No abstract available.

  PMID: 33038472 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Hemoglobin A1c (HbA1c), hemoglobin level, fasting plasma glucose, ALAT, cholesterol, triglyceride levels, creatinine, potassium, sodium, thyroid-stimulating hormone, high-sensitivity C-reactive protein, high-sensitivity TNT and NT-pro-brain natriuretic peptide

MeSH Terms

Conditions

Hidradenitis; Hidradenitis Suppurativa; Hidradenitis suppurativa, familial; Ventricular Dysfunction, Left; Myocardial Infarction; Myocardial Ischemia; Heart Failure; Stroke; Heart Diseases; Heart Failure, Systolic; Heart Failure, Diastolic; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Sweat Gland Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Bacterial; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Suppuration; Ventricular Dysfunction; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Tor Biering-Sørensen, MD PhD MPH

  Department of Cardiology, Herlev and Gentofte University Hospital, University of Copenhagen

  STUDY DIRECTOR

• Claus Zachariae, MD DMSc

  Department of Dermato-Allergology, Herlev and Gentofte University Hospital, University of Copenhagen

  STUDY DIRECTOR

• Lone Skov, MD PhD DMSc

  Department of Dermato-Allergology, Herlev and Gentofte University Hospital, University of Copenhagen

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, fellow

Study Record Dates

• First Submitted: August 4, 2023
• First Posted: August 14, 2023
• Study Start: August 1, 2023
• Primary Completion: January 6, 2025
• Study Completion (Estimated): August 1, 2033
• Last Updated: August 1, 2025

Record last verified: 2025-07

Locations

DK (1)