Clinical Trial: Primary Aldosteronism in Western Norway

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title: Primary Aldosteronism: a Study of Diagnostic Approach and Treatment Outcome in Western Norway

Brief Summary: In this study the investigators aim to identify and include all patients with Primary Aldosteronism (PA) diagnosed in the Western and Mid-parts of Norway, to describe the characteristics of these patients, to explore the cardiac effects of PA, and to identify the long-term patient outcome after treatment. A subgroup of the included PA-patients perform Cardiac MRI to assess myocardial function in rest and during stress, myocardial mass and myocardial fibrosis, compared to a group of healthy controls.

Detailed Summary:

From June 2013, all newly diagnosed patients with Primary Aldosteronism (PA) either diagnosed at Haukeland University Hospital (HUS) or admitted to HUS for subtype testing with adrenal vein sampling, have been asked for inclusion in the study. All included patients have a base-line study visit where baseline blood samples ar collected, and a 24h blood-pressure-monitoring and echocardiography is performed. After start of definite medical or surgical treatment the patients are followed up with regularly new study visits.

A subgroup of the included PA-study patients also perform a Cardiac MRI. Cine-MRI, velocity-encoded MRI, MRI images during continuous adenosine infusion and MRI images at after gadolinium contrast injection are performed, and compared to a group of age- and sex-matched healthy controls.


Sponsor: Haukeland University Hospital

Current Primary Outcome: Long-term blood-pressure outcome after surgical and medical treatment of PA [ Time Frame: 5 years ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Myocardial mass in PA-patients before and after treatment [ Time Frame: 2 years ]
    Left ventricular mass is measured before and after treatment
  • Myocardial function in PA-patients before and after treatment [ Time Frame: 2 years ]
    Ejection fraction is measured in rest and during stress before and after treatment
  • Quality of life in PA-patients before and after treatment [ Time Frame: 5 years ]
    Quality of life is measured in PA-patients before, 1 year and 5 years after treatment by Medical Outcomes Study Short Form 36 (SF-36) quality of life form.


Original Secondary Outcome: Same as current

Information By: Haukeland University Hospital

Dates:
Date Received: January 25, 2016
Date Started: June 2013
Date Completion: December 2030
Last Updated: July 11, 2016
Last Verified: July 2016