Primary HyperaldosteronismNCT04251780
Tissue K+ in Primary Hyperaldosteronism
An observational study of Primary Hyperaldosteronism and Electrolyte Disturbance, run by University of Erlangen-Nürnberg Medical School at 2 sites in Germany.
Trial summary
Recent human studies found tissue sodium storage in patients with hyperaldosteronism that could be detected non-invasively by 23Na-MRI. Tissue sodium accumulation could be mobilized upon treatment of hyperaldosteronism. Read more about this study
- Who is it for?
- Ages 18 to 95 yearsHealthy volunteers can take part
- Conditions the study is for
- Primary Hyperaldosteronism, Electrolyte Disturbance
- What is being tested?
- Surgical Treatment of Primary Aldosteronism and Drug treatment of Primary Aldosteronism
- Type of treatment
- Surgery or procedure
- How many people
- 21 participants
- Where
- 2 sitesGermany
- Study dates
- 1 Jan 2018to 24 Apr 2024
- How long will I take part?
- 4 Months
- 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 to 95 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients diagnosed with Primary Aldosteronism Healthy participants
Who may be able to join
- Primary Aldosteronism diagnosed according to the endocrinological guideline (J Clin Endocrinology \& Metabolism, May 2016) without specific medication
- Age > 18 years
- Age > 18 years
Who cannot join
- Chronic kidney disease ≤ 3b (estimated GFR <45 ml/min according to CKD-EPI)
- Active malignancy
- Severe congestive heart failure (NYHA III and IV)
- Liver cirrhosis (Child B and C)
- Acute infection
- Recent major surgical procedures (<3 months)
Show all 13Show fewer
- Pregnancy
- Contraindications for MRI measurements: cardiac pacemaker, claustrophobia, etc.
- Medical history of chronic disease (such as diabetes, hypertension, chronic kidney disease etc.)
- regular medication
- blood pressure ≥ 140/90 mmHg
- Pregnancy
- Contraindications for MRI measurements: cardiac Pacemaker, claustrophobia, etc.
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
Nephrology Department, University Hospital Erlangen
Erlangen, Bavaria, 91054
Radiology Department, University Hospital Erlangen
Erlangen, Bavaria, 91054
About this study
Official title: Changes in Tissue Potassium Amount Before and After Treatment of Primary Hyperaldosteronism Assessed by 39K-MRI
Recent human studies found tissue sodium storage in patients with hyperaldosteronism that could be detected non-invasively by 23Na-MRI. Tissue sodium accumulation could be mobilized upon treatment of hyperaldosteronism. Besides, former animal studies applying chemical electrolyte analysis indicate that this aldosterone induced sodium storage might be accompanied by intracellular potassium loss. Wether such an intracellular tissue potassium loss occurs in vivo in patients with hyperaldosteronism and if this deficiency can be corrected by treatment is unclear. The investigators will employ 39K-MR Imaging at 7Tesla to further assess this hypothesis.
Read the detailed description
Patients diagnosed with primary hyperaldosteronism (PA) will be prospetively investigated using 23Na-MRI and 39K-MRI at 7 Tesla to assess tissue sodium and potassium content (prospective observational study). Measurements will be conducted before treatment of hyperaldosteronism and three to four months after adrenal surgery or medical treatment (Spironolactone or Eplerenone). Furthermore, blood pressure, body water distribution (by bioimpedance spectroscopy), pulse wave velocity and serum electrolytes will be assessed.
Additionally, we will conduct a case-control study and compare PA patients before treatment with age- and gender matched healthy control participants. In this study group 23Na-MRI and 39K-MRI at 7 Tesla will be conducted to assess tissue sodium and potassium content using the same MRI protocols as in PA patients. Blood pressure, body water distribution (by bioimpedance spectroscopy), pulse wave velocity and serum electrolytes will be also examined.
- Being tested
- Surgical Treatment of Primary Aldosteronism, Drug treatment of Primary Aldosteronism
- Keywords
- Hyperaldosteronism, Potassium, Magnetic Resonance Imaging
- Medical subject headings
- Hyperaldosteronism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical Treatment of Primary AldosteronismProcedure or surgery
Also called Adrenalectomy
Surgery of an unilateral adrenal disease
Drug treatment of Primary AldosteronismDrug
Also called Medication
Treatment of Primary Aldosteronism with Spironolactone or Eplerenone.
| Study group | Role | What they receive |
|---|---|---|
| Patients with Primary Aldosteronism | Patients with primary Aldosteronism will either be treated by adrenalectomy (in case of unilateral adrenal disease) or receive medical treatment (Spironolactone/Eplerenone; bilateral hyperplasia) as specified in the endocrinological guideline (J Clin Endocrinology \& Metabolism, May 2016). Before and after intervention tissue sodium and tissue potassium amount will be assessed by MRI. Receives: Procedure: Surgical Treatment of Primary Aldosteronism; Drug: Drug treatment of Primary Aldosteronism | |
| Control group | Healthy participants, age- and gender-matched with the Primary Aldosteronism patients. Tissue sodium and tissue potassium amount of the healthy control group will be assessed by MRI and compared to the tissue sodium and potassium amount of the patients with Primary Aldosteronism before treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tissue potassium content
- Change in tissue potassium content measured by MRI before and after treatment of Primary Aldosteronism
- Difference in tissue potassium content between patients with Primary Aldosteronism before treatment and healthy control subjects
Measured: 3-6 months after intervention
Secondary outcomes (4)
Tissue sodium content
- Change in tissue sodium content measured by MRI before and after treatment of Primary Aldosteronism
- Difference in tissue sodium content between patients with Primary Aldosteronism before treatment and healthy control subjects
Measured: 3-6 months after intervention
Blood pressure
Change in blood pressure (systolic/diastolic/mean) before and after treatment of Primary Aldosteronism
Measured: 3-6 months after intervention
Water balance
- Change in water distribution (intra-/extracellular water, total water, overhydration) assessed by bioimpedance spectroscopy before and after treatment of Primary Aldosteronism
- Difference in water distribution (intra-/extracellular water, total water, overhydration) assessed by bioimpedance spectroscopy between patients with Primary Aldosteronism before treatment and healthy control subjects
Measured: 3 - 6 months after intervention
Pulse wave velocity
- Change in pulse wave velocity measured by SphygmoCor before and after treatment of Primary Aldosteronism
- Difference in pulse wave velocity between patients with Primary Aldosteronism before treatment and healthy control subjects
Measured: 3 - 6 months after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start1 Jan 2018
- Primary completion24 Apr 2024
- Study completion24 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Primary HyperaldosteronismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Other
- Time perspective
- Prospective
- Enrolment
- 21 participants (actual)
- Target duration
- 4 Months
Sponsor and investigators
- Lead sponsor
- University of Erlangen-Nürnberg Medical School
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christoph Kopp, MD, Principal investigator, Nephrology Department, University Erlangen-Nurnberg, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04251780
- Sponsor's protocol ID
- ConnK+
- Status last verified
- Sep 2025
- First submitted
- 30 Jan 2020
- Last updated
- 25 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Kopp C, Linz P, Wachsmuth L, Dahlmann A, Horbach T, Schofl C, Renz W, Santoro D, Niendorf T, Muller DN, Neininger M, Cavallaro A, Eckardt KU, Schmieder RE, Luft FC, Uder M, Titze J. (23)Na magnetic resonance imaging of tissue sodium. Hypertension. 2012 Jan;59(1):167-72. doi: 10.1161/HYPERTENSIONAHA.111.183517. Epub 2011 Dec 5.
PubMed 22146510Funder JW, Carey RM, Mantero F, Murad MH, Reincke M, Shibata H, Stowasser M, Young WF Jr. The Management of Primary Aldosteronism: Case Detection, Diagnosis, and Treatment: An Endocrine Society Clinical Practice Guideline. J Clin Endocrinol Metab. 2016 May;101(5):1889-916. doi: 10.1210/jc.2015-4061. Epub 2016 Mar 2.
PubMed 26934393Kopp C, Dahlmann A, Gast L, Linz P, Frielinghaus J, Breunig P, Strobel A, Bauerle T, Kurzinger L, Luft FC, Schiffer M, Uder M, Nagel AM. 7-T Potassium (39K) MRI to Assess Muscle K+ Depletion in Primary Aldosteronism. Radiology. 2026 Mar;318(3):e252004. doi: 10.1148/radiol.252004.
PubMed 41773968
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Tissue Potassium Amount Before and After Treatment of Primary Hyperaldosteronism Assessed by 39K-MRI
- ClinicalTrials.gov ID
- NCT04251780
- Acronym / sponsor ID
- ConnK+
- Keywords
- Hyperaldosteronism, Potassium, Magnetic Resonance Imaging
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University of Erlangen-Nürnberg Medical SchoolUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 24 Apr 2024 (actual)
- Study completion
- 24 Apr 2024 (actual)
- First posted
- 5 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Recent human studies found tissue sodium storage in patients with hyperaldosteronism that could be detected non-invasively by 23Na-MRI. Tissue sodium accumulation could be mobilized upon treatment of hyperaldosteronism. Besides, former animal studies applying chemical electrolyte analysis indicate that this aldosterone induced sodium storage might be accompanied by intracellular potassium loss. Wether such an intracellular tissue potassium loss occurs in vivo in patients with hyperaldosteronism and if this deficiency can be corrected by treatment is unclear. The investigators will employ 39K-MR Imaging at 7Tesla to further assess this hypothesis.
Detailed description
Patients diagnosed with primary hyperaldosteronism (PA) will be prospetively investigated using 23Na-MRI and 39K-MRI at 7 Tesla to assess tissue sodium and potassium content (prospective observational study). Measurements will be conducted before treatment of hyperaldosteronism and three to four months after adrenal surgery or medical treatment (Spironolactone or Eplerenone). Furthermore, blood pressure, body water distribution (by bioimpedance spectroscopy), pulse wave velocity and serum electrolytes will be assessed.
Additionally, we will conduct a case-control study and compare PA patients before treatment with age- and gender matched healthy control participants. In this study group 23Na-MRI and 39K-MRI at 7 Tesla will be conducted to assess tissue sodium and potassium content using the same MRI protocols as in PA patients. Blood pressure, body water distribution (by bioimpedance spectroscopy), pulse wave velocity and serum electrolytes will be also examined.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 4 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with Primary Aldosteronism | – | Procedure: Surgical Treatment of Primary Aldosteronism, Drug: Drug treatment of Primary AldosteronismPatients with primary Aldosteronism will either be treated by adrenalectomy (in case of unilateral adrenal disease) or receive medical treatment (Spironolactone/Eplerenone; bilateral hyperplasia) as specified in the endocrinological guideline (J Clin Endocrinology \& Metabolism, May 2016). Before and after intervention tissue sodium and tissue potassium amount will be assessed by MRI. |
| Control group | – | –Healthy participants, age- and gender-matched with the Primary Aldosteronism patients. Tissue sodium and tissue potassium amount of the healthy control group will be assessed by MRI and compared to the tissue sodium and potassium amount of the patients with Primary Aldosteronism before treatment. |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with Primary Aldosteronism Healthy participants
Key inclusion criteria (3 listed)
- Primary Aldosteronism diagnosed according to the endocrinological guideline (J Clin Endocrinology \& Metabolism, May 2016) without specific medication
- Age > 18 years
- Age > 18 years
Key exclusion criteria (13 listed)
- Chronic kidney disease ≤ 3b (estimated GFR <45 ml/min according to CKD-EPI)
- Active malignancy
- Severe congestive heart failure (NYHA III and IV)
- Liver cirrhosis (Child B and C)
- Acute infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Surgical Treatment of Primary AldosteronismAlso: AdrenalectomySurgery of an unilateral adrenal disease | Procedure or surgery | Patients with Primary Aldosteronism |
| Drug treatment of Primary AldosteronismAlso: MedicationTreatment of Primary Aldosteronism with Spironolactone or Eplerenone. | Drug | Patients with Primary Aldosteronism |
Primary outcome
Tissue potassium content
Time frame: 3-6 months after intervention
1. Change in tissue potassium content measured by MRI before and after treatment of Primary Aldosteronism 2. Difference in tissue potassium content between patients with Primary Aldosteronism before treatment and healthy control subjects
4 secondary outcomes
Tissue sodium content
Time frame: 3-6 months after intervention
Blood pressure
Time frame: 3-6 months after intervention
Water balance
Time frame: 3 - 6 months after intervention
Pulse wave velocity
Time frame: 3 - 6 months after intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2025.
- Results publication: PubMed 22146510Kopp C, Linz P, Wachsmuth L, Dahlmann A, Horbach T, Schofl C, Renz W, Santoro D, Niendorf T, Muller DN, Neininger M, Cavallaro A, Eckardt KU, Schmieder RE, Luft FC, Uder M, Titze J. (23)Na magnetic resonance imaging of tissue sodium. Hypertension. 2012 Jan;59(1):167-72. doi: 10.1161/HYPERTENSIONAHA.111.183517. Epub 2011 Dec 5.
- Results publication: PubMed 26934393Funder JW, Carey RM, Mantero F, Murad MH, Reincke M, Shibata H, Stowasser M, Young WF Jr. The Management of Primary Aldosteronism: Case Detection, Diagnosis, and Treatment: An Endocrine Society Clinical Practice Guideline. J Clin Endocrinol Metab. 2016 May;101(5):1889-916. doi: 10.1210/jc.2015-4061. Epub 2016 Mar 2.
- Derived from this study: PubMed 41773968Kopp C, Dahlmann A, Gast L, Linz P, Frielinghaus J, Breunig P, Strobel A, Bauerle T, Kurzinger L, Luft FC, Schiffer M, Uder M, Nagel AM. 7-T Potassium (39K) MRI to Assess Muscle K+ Depletion in Primary Aldosteronism. Radiology. 2026 Mar;318(3):e252004. doi: 10.1148/radiol.252004.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christoph Kopp, MD principal investigator
Nephrology Department, University Erlangen-Nurnberg, Germany
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Primary Hyperaldosteronism and Electrolyte Disturbance, run by University of Erlangen-Nürnberg Medical School at 2 sites 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 3 inclusion and 13 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 25 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Tissue potassium content (time frame: 3-6 months after intervention). 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 NCT04251780, which also lists 3 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 25 Nov 2025.