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Trial record 6 of 9 for:    9099655 [PUBMED-IDS]

Blood Pressure Regulation - Role of Potassium

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ClinicalTrials.gov Identifier: NCT02380157
Recruitment Status : Completed
First Posted : March 5, 2015
Last Update Posted : January 6, 2017
Sponsor:
Collaborator:
Danish Heart Foundation
Information provided by (Responsible Party):
Rasmus Dreier, Glostrup University Hospital, Copenhagen

Brief Summary:

Project titel: Oral potassium supplementation in healthy men - interactions with the renin-angiotensin-aldosterone system and the sympathetic nervous system Protocol number: KARAASS-1 EudraCT number: 2013-004460-66

Introduction The global burden of hypertension is huge. This project focuses on the role of potassium in human blood pressure regulation. A potassium rich diet lowers blood pressure and some studies have shown an increase in blood pressure during potassium depletion. Thus an inverse correlation between potassium intake and blood pressure exists. In this trial the objective is to test how an oral potassium supplementation, administered in form of the drug Kaleorid®, interacts with the renin-angiotensin-aldosterone system and the sympathetic nervous system.

Methods This is a randomized clinical placebo-controlled double-blinded crossover trial. A group of healthy men will be randomized to either 4 weeks treatment with the drug Kaleorid®, 750mg, 3 tablets 3 times daily or to 4 weeks treatment with placebo.

On day 26 in the first treatment period the participants meet at the hospital to start a 24-hours ambulatory blood pressure and collect a 48-hours urine sample. The same day a blood sample, an electrocardiogram (ECG) and a fat biopsy from the gluteal region will be done. The fat biopsy is expected to contain resistance vessels, which are to be investigated further in the laboratory.

On day 28 in the first treatment period the participants meet at the hospital again and are tested with an intravenous Angiotensin II infusion followed by continuous measurement of blood pressure and the following aldosterone response (using blood samples). Blood pressure will be measured with Finger Plethysmography and vascular tonus will be evaluated with the use of Impedance Cardiography, Finger Plethysmography and Doppler Ultrasound measurements of blood flow before, during and after the Angiotensin II infusion.

After this first period of treatment and testing a "washout" period of two weeks is inserted. After "washout", the participants crossover and starts the second treatment period.

Feasibility All necessary authorities have approved the trial and all cooperation is established.


Condition or disease Intervention/treatment Phase
Blood Pressure Hypertension Drug: Kaleorid, 750mg (trade name), Potassium chloride (active substance) Drug: Placebo Phase 4

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Oral Potassium Supplementation in Healthy Men - Interactions With the Renin-angiotensin-aldosterone System and the Sympathetic Nervous System
Study Start Date : March 2015
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Potassium
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Kaleorid
4 weeks treatment with Kaleorid, 750mg, 3 tablets 3 times daily.
Drug: Kaleorid, 750mg (trade name), Potassium chloride (active substance)
4 weeks treatment with Kaleorid, 750mg, 3 tablets 3 times daily.
Placebo Comparator: Placebo
4 weeks treatment with Placebo tablets, 3 tablets 3 times daily.
Drug: Placebo
4 weeks treatment with Placebo tablets, 3 tablets 3 times daily.



Primary Outcome Measures :
  1. Change in Angiotensin II stimulated S-aldosterone [ Time Frame: Day 28 in each treatment period up to 70 days from start in the study ]

Secondary Outcome Measures :
  1. Change in Angiotensin II stimulated blood pressure [ Time Frame: Day 28 in each treatment period up to 70 days from start in the study ]
  2. Change in Angiotensin II stimulated total peripheral resistance (TPR) [ Time Frame: Day 28 in each treatment period up to 70 days from start in the study ]
  3. Change in Angiotensin II stimulated resistance index (RI) in central vessels of the abdomen [ Time Frame: Day 28 in each treatment period up to 70 days from start in the study ]
  4. Level of receptor expression in resistance vessels from fat biopsies [ Time Frame: Day 26 in each treatment period up to 70 days from start in the study ]
  5. Level of receptor function in resistance vessels from fat biopsies [ Time Frame: Day 26 in each treatment period up to 70 days from start in the study ]
  6. P-epinephrine [ Time Frame: Day 26 in each treatment period up to 70 days from start in the study ]
  7. P-norepinephrine [ Time Frame: Day 26 in each treatment period up to 70 days from start in the study ]
  8. Urinary content of epinephrine [ Time Frame: Day 26 in each treatment period up to 70 days from start in the study ]
  9. Urinary content of norepinephrine [ Time Frame: Day 26 in each treatment period up to 70 days from start in the study ]
  10. Change in Angiotensin II stimulated P-epinephrine [ Time Frame: Day 28 in each treatment period up to 70 days from start in the study ]
  11. Change in Angiotensin II stimulated P-norepinephrine [ Time Frame: Day 28 in each treatment period up to 70 days from start in the study ]


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Ages Eligible for Study:   20 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male
  • Age: 20-55
  • Office Blood Pressure: < 140/90 mmHg
  • BMI: 18,5-30,0 kg/m2
  • Signed consent form

Exclusion Criteria:

  • Diabetes mellitus
  • Cerebrovascular disease, ischemic heart disease, peripheral artery disease
  • Kidney disease
  • Adrenal disease
  • Ulcers
  • Medical treatment
  • Drug or alcohol abuse
  • Pathological ECG
  • Mental not suitable
  • Hyperkalemia

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02380157


Locations
Denmark
Department of Clinical Physiology and Nuclear Medicine, Glostrup Hospital, University of Copenhagen
Glostrup, Copenhagen, Glostrup, Denmark, DK-2600
Sponsors and Collaborators
Glostrup University Hospital, Copenhagen
Danish Heart Foundation
Investigators
Principal Investigator: Rasmus Dreier, M.D. Department of Clinical Physiology and Nuclear Medicine, Glostrup Hospital, University of Copenhagen

Publications:
15. Egfjord M, Dreier R, Ravn L, Hofman-Bang J. Extracellular potassium modulated aldosterone secretion in relation to hypertensive states. 2013. Submitted.

Responsible Party: Rasmus Dreier, Medical Doctor, Glostrup University Hospital, Copenhagen
ClinicalTrials.gov Identifier: NCT02380157     History of Changes
Other Study ID Numbers: KARAASS-1
First Posted: March 5, 2015    Key Record Dates
Last Update Posted: January 6, 2017
Last Verified: January 2017

Keywords provided by Rasmus Dreier, Glostrup University Hospital, Copenhagen:
Blood pressure
Potassium, Dietary
Renin-angiotensin-aldosterone system
Sympathetic nervous system