Cardiovascular Status in Adrenal Insufficiency

NCT03426319 | Completed

• 1 other identifier: CV-CORT-AI
• Study Type: observational
• Target: 68
• Locations: 1 country
• Sites: 1

Brief Summary

Within this trial, the cardiovascular status and metabolic profile of patients with chronic primary adrenal insufficiency is evaluated.

Conditions

Adrenal Insufficiency

Keywords

Primary adrenal insufficiency; Cardiovascular status; Metabolic profile

Outcome Measures

Primary Outcomes (13)

• Cardiovascular status - anamnesis

  Evaluation of the cardiovascular status of patients with chronic adrenal insufficiency by anamnesis/documentation of cardiovascular risk factors. Prevalence of cardiovascular risk factors (diabetes, hypertension, hyperlipidemia, obesity) in participating patients.

  12 months

• Cardiovascular status - mean systolic blood pressure

  Measurement of the systolic resting blood pressure (in mmHg). Analysis of the mean systolic blood pressure (of all participating patients) and the number of patients with increased systolic blood pressure (\>140 mmHg).

  12 months

• Cardiovascular status - mean diastolic blood pressure

  Measurement of the diastolic resting blood pressure (in mmHg). Analysis of the mean diastolic blood pressure (of all participating patients).

  12 months

• Cardiovascular status - mean BMI

  Measurement of weight (in kg) and height (qm); weight and height will be combined to report the Body Mass Index/BMI (kg/qm). Analysis of the mean BMI (of all participating patients) and the number of patients with increased BMI (\>25 kg/qm).

  12 months

• Cardiovascular status - mean HbA1c

  Measurement of HbA1c-values (in %). Analysis of the mean HbA1c-value and the number of patients with increased HbA1c (\>6.5%).

  12 months

• Cardiovascular status - mean cholesterol-level

  Measurement of cholesterol-levels (in mg/dl). Analysis of the mean cholesterol-level and the number of patients with increased cholesterol-levels (\>200mg/dl).

  12 months

• Cardiovascular status - mean triglyceride-level

  Measurement of triglyceride-levels (in mg/dl). Analysis of the mean triglyceride-level and the number of patients with increased triglyceride-levels (\>200mg/dl).

  12 months

• Cardiovascular status - reactive hyperaemia index

  Evaluation of the reactive hyperaemia index (endothelial function). Analysis of the number of patients with a pathological reactive hyperaemia index (pathological results ≤ 1.67).

  12 months

• Cardiovascular status - mean systolic blood pressure (24h blood pressure measurement)

  Measurement of the mean systolic blood pressure (in mmHg) by 24h blood pressure profiles. Analysis of the mean systolic blood pressure (of all participating patients) and the number of patients with an increased mean systolic blood pressure (\>140 mmHg).

  12 months

• Cardiovascular status - non-dipper-profiles

  Documentation of the number of patients with a non-dipper-profile during a 24h blood pressure measurement.

  12 months

• Cardiovascular status - mean ejection fraction

  Analysis of the mean ejection fraction (in %) (by echocardiography of all participating patients) and the number of patients with a pathologic ejection fraction (\<55%).

  12 months

• Cardiovascular status - diastolic function

  Measurement of the diastolic function by echocardiography. Analysis of the number of patients with a pathological diastolic function (E/A ratio; values \<1 were rated as pathological).

  12 months

• Cardiovascular status - pathological cardiac MRI

  Number of patients with pathological results (ejection fraction (\<55%), pericardial effusion, thrombus, adipose tissue, perfusion defects, late enhancement, valvular or wall motion abnormalities).

  12 months

Study Arms (1)

Primary adrenal insufficiency

Patients with primary adrenal insufficiency on hormone replacement therapy with hydrocortisone.

Diagnostic Test: Cardiovascular evaluation

Interventions

Cardiovascular evaluation DIAGNOSTIC_TEST

Cardiovascular evaluation includes anamnesis, physical examination, laboratory tests, analysis of endothelial function, 24h blood pressure profile, Holter ECG, echocardiography and cardiac MRI.

Primary adrenal insufficiency

Eligibility Criteria

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

Study Population

Patients with chronic primary adrenal insufficiency

You may qualify if:

• Chronic primary adrenal insufficiency
• Adequate hormone replacement therapy (\>3 years)
• Age \>18 years
• Patient's informed consent

You may not qualify if:

• Hormone replacement therapy with an other glucocorticoid than hydrocortisone
• Pharmacotherapy with glucocorticoids
• Congenital adrenal hyperplasia
• Coronary heart disease
• Heart failure
• Systemic disease with (potential) cardiac involvement (e.g. amyloidosis, lung fibrosis)
• Pregnancy
• Chronic alcohol abuse
• Malignant disease
• Arterial hypertension
• Chronic renal failure (MDRD \<60)

Sponsors & Collaborators

• Wuerzburg University Hospital: lead

Study Sites (1)

University Hospital Wuerzburg

Würzburg, 97080, Germany

Location

Related Publications (6)

• Bergthorsdottir R, Leonsson-Zachrisson M, Oden A, Johannsson G. Premature mortality in patients with Addison's disease: a population-based study. J Clin Endocrinol Metab. 2006 Dec;91(12):4849-53. doi: 10.1210/jc.2006-0076. Epub 2006 Sep 12.

  PMID: 16968806 BACKGROUND

• Erichsen MM, Lovas K, Skinningsrud B, Wolff AB, Undlien DE, Svartberg J, Fougner KJ, Berg TJ, Bollerslev J, Mella B, Carlson JA, Erlich H, Husebye ES. Clinical, immunological, and genetic features of autoimmune primary adrenal insufficiency: observations from a Norwegian registry. J Clin Endocrinol Metab. 2009 Dec;94(12):4882-90. doi: 10.1210/jc.2009-1368. Epub 2009 Oct 26.

  PMID: 19858318 BACKGROUND

• Filipsson H, Johannsson G. GH replacement in adults: interactions with other pituitary hormone deficiencies and replacement therapies. Eur J Endocrinol. 2009 Nov;161 Suppl 1:S85-95. doi: 10.1530/EJE-09-0319. Epub 2009 Aug 14.

  PMID: 19684055 BACKGROUND

• Johannsson G, Nilsson AG, Bergthorsdottir R, Burman P, Dahlqvist P, Ekman B, Engstrom BE, Olsson T, Ragnarsson O, Ryberg M, Wahlberg J, Biller BM, Monson JP, Stewart PM, Lennernas H, Skrtic S. Improved cortisol exposure-time profile and outcome in patients with adrenal insufficiency: a prospective randomized trial of a novel hydrocortisone dual-release formulation. J Clin Endocrinol Metab. 2012 Feb;97(2):473-81. doi: 10.1210/jc.2011-1926. Epub 2011 Nov 23.

  PMID: 22112807 BACKGROUND

• Burger-Stritt S, Pulzer A, Hahner S. Quality of Life and Life Expectancy in Patients with Adrenal Insufficiency: What Is True and What Is Urban Myth? Front Horm Res. 2016;46:171-83. doi: 10.1159/000443918. Epub 2016 May 17.

  PMID: 27211797 BACKGROUND

• Stewart PM, Biller BM, Marelli C, Gunnarsson C, Ryan MP, Johannsson G. Exploring Inpatient Hospitalizations and Morbidity in Patients With Adrenal Insufficiency. J Clin Endocrinol Metab. 2016 Dec;101(12):4843-4850. doi: 10.1210/jc.2016-2221. Epub 2016 Sep 13.

  PMID: 27623069 BACKGROUND

MeSH Terms

Conditions

Adrenal Insufficiency; Addison Disease

Condition Hierarchy (Ancestors)

Adrenal Gland Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2018
• First Posted: February 8, 2018
• Study Start: August 1, 2013
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: February 8, 2018

Record last verified: 2018-01

Locations

DE (1)