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Adrenal InsufficiencyCVCORT-AINCT03426319

Cardiovascular Status in Adrenal Insufficiency

An observational study of Adrenal Insufficiency, run by Wuerzburg University Hospital at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 18 years and older
Conditions the study is for
Adrenal Insufficiency
What is being tested?
Cardiovascular evaluation
How many people
68 participants
Where
1 siteGermany
Study dates
Aug 2013to Jun 2014
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients with chronic primary adrenal insufficiency

Who may be able to join

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

Who cannot join

  • 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)
Show all 11Show fewer
  • Pregnancy
  • Chronic alcohol abuse
  • Malignant disease
  • Arterial hypertension
  • Chronic renal failure (MDRD <60)

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • University Hospital Wuerzburg

    Würzburg, 97080

Other trials in Germany

About this study

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

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

Read the detailed 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).

Being tested
Cardiovascular evaluation
Keywords
Primary adrenal insufficiency, Cardiovascular status, Metabolic profile
Medical subject headings
Adrenal Insufficiency, Addison Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cardiovascular evaluationDiagnostic test

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

Study groups in NCT03426319
Study groupRoleWhat they receive
Primary adrenal insufficiencyPatients with primary adrenal insufficiency on hormone replacement therapy with hydrocortisone.
Receives: Diagnostic Test: Cardiovascular evaluation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 12 months

  2. 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).

    Measured: 12 months

  3. 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).

    Measured: 12 months

  4. 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).

    Measured: 12 months

  5. 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%).

    Measured: 12 months

  6. 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).

    Measured: 12 months

  7. 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).

    Measured: 12 months

  8. 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).

    Measured: 12 months

  9. 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).

    Measured: 12 months

  10. Cardiovascular status - non-dipper-profiles

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

    Measured: 12 months

  11. 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%).

    Measured: 12 months

  12. 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).

    Measured: 12 months

  13. 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).

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Feb 2018
  2. Study startAug 2013
  3. Primary completionJun 2014
  4. Study completionJun 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Cross-sectional
Enrolment
68 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03426319
Sponsor's protocol ID
CV-CORT-AI
Acronym
CVCORT-AI
Status last verified
Jan 2018
First submitted
8 Jan 2018
Last updated
8 Feb 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 16968806

  • 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.

    PubMed 19858318

  • 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.

    PubMed 19684055

  • 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.

    PubMed 22112807

  • 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.

    PubMed 27211797

  • 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.

    PubMed 27623069

Questions about this trial

What is this clinical trial studying?

An observational study of Adrenal Insufficiency, run by Wuerzburg University Hospital at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cardiovascular status - anamnesis (time frame: 12 months). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03426319, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2018.

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