Cardiovascular Status in Adrenal Insufficiency

Adrenal Insufficiency Clinical Trial

— CVCORT-AI  

Official title:

Cardiovascular Status in Patients With Chronic Cortisol Deficiency (Adrenal Insufficiency)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03426319
• Other study ID #: CV-CORT-AI
• Status: Completed
• Phase: N/A
• First received: January 8, 2018
• Last updated: February 1, 2018
• Start date: August 2013
• Est. completion date: June 2014

Study information

• Verified date: January 2018
• Source: Wuerzburg University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Description:

An unfavorable metabolic profile in patients with adrenal insufficiency (AI) under hormone replacement therapy with hydrocortisone (HC) has been revealed in one recent analysis. Furthermore an increased cardiovascular (CV) morbidity in AI is assumed. The aim of the study is to evaluate the metabolic profile and cardiovascular status in patients with primary AI. Patients with primary AI under standard replacement therapy with HC undergo detailed CV evaluation (including e.g. laboratory test, analysis of endothelial function, 24h blood pressure profile, Holter ECG, echocardiography and cardiac MRI).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Chronic primary adrenal insufficiency

• Adequate hormone replacement therapy (>3 years)

• Age >18 years

• Patient's informed consent

Exclusion Criteria:

• 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)

Related Conditions & MeSH terms

• Adrenal Insufficiency

Intervention

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

Locations

Country	Name	City	State
Germany	University Hospital Wuerzburg	Wuerzburg

Sponsors (1)

Lead Sponsor	Collaborator
Wuerzburg University Hospital

Country where clinical trial is conducted

Germany, 

References & Publications (6)

Bergthorsdottir R, Leonsson-Zachrisson M, Odén 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. Epub 2006 Sep 12. — View Citation

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. Review. — View Citation

Erichsen MM, Løvås 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. — View Citation

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. Review. — View Citation

Johannsson G, Nilsson AG, Bergthorsdottir R, Burman P, Dahlqvist P, Ekman B, Engström BE, Olsson T, Ragnarsson O, Ryberg M, Wahlberg J, Biller BM, Monson JP, Stewart PM, Lennernäs 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. — View Citation

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. Epub 2016 Sep 13. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Cardiovascular status - non-dipper-profiles	Documentation of the number of patients with a non-dipper-profile during a 24h blood pressure measurement.	12 months
Primary	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
Primary	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
Primary	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