Myocardial sodium content in Cardiac disease study-a clinical study to determine the sodium content in the myocardium and skeletal muscle

• Conditions: Healthy volunteers; E26.0; I10; Primary hyperaldosteronism; Essential (primary) hypertension

• Registration Number: DRKS00010946
• Lead Sponsor: Deutsches Zentrum für Herzinsuffizienz Würzburg/ Comprehensive Heart Failure Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-03-20
• Study Completion: 2018-02-01
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

PHA patients have to present an aldosterone-renin-ratio of at least 25 or higher, as well as a positive saline infusion test.
Patients with essential hypertension had a mean systolic blood pressure of 136 mmHg or higher.
HC subjects had to be antihypertensive drug naïve with a mean systolic blood pressure of 135 mmHg or lower, measured by 24h ambulatory blood pressure registration.

Exclusion Criteria

- ineligible for MR imaging
- known previous cardiac illness
- chronic renal failure or a GFR < 30
- chronic liver diseases
- systemic diseases affecting the heart or the lungs
- treatment with aldosterone receptor antagonists or systemic glucocorticoids
- pregnancy/nursing period

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1) Detection and Quantification of the sodium content in the heart via sodium MRI in all three groups<br>2) Detection and Quantification of the myocardial sodium content in the PHA group prior and after a treatment (either surgery or medical treatment with a mineralocorticoid receptor antagonist)

Secondary Outcome Measures

Name	Time	Method
1) Detection and Quantification of the sodium content in the calf muscle via sodium MRI in all three groups<br>2) Detection and Quantification of the skeletal sodium content in the PHA group prior and after a treatment (either surgery or medication with an mineralocorticoid receptor antagonist)<br>3) Comparison of various cardiovascular parameters regarding cardiac dimension, function (echocardiography), mass and fibrosis (MRI; late gadolinium enhancement)